In an effort to get ahead of a potential tripledemic this winter of COVID-19, flu, and RSV that could overwhelm hospitals, health officials have re-booted an important program: making COVID test kits free again. Those kits will be available by mail to households starting September 25.

Next comes the hard part: convincing enough people to get the kits and then persuading them to follow quarantine guidelines if they or their family members get sick.

This is not the time to roll out stale messaging delivered by a carousel of health officials trying to convince the public to get the test kits. Americans are weary of being told to keep their guard up against a disease that many view as more of an inconvenience than a threat. If the sales pitch to get the kits is off, health officials may find that the test kits no longer serve as an effective public health tool. Instead, they could become another partisan symbol of perceived government overreach, further impeding people’s freedom to live as they want.

In short, we have a messaging challenge ahead of us, and if we haven’t taken to heart the lessons learned during the worst early days of the pandemic, we’re doomed to repeat mistakes that cost lives.

How can we be more thoughtful about containing COVID and other dangerous diseases? To generate greater public compliance for fighting an endemic disease, communicators must provide a credible and compelling case of the risk of inaction and convince people that ignorance – of not knowing your infection status – is greater than the cost of knowing. These can be very high bars to clear since people have different thresholds for risk and for being informed.

It’s likely we won’t clear those hurdles with the roll-out of the free test kits. Because the perceived risk of COVID-19 infection and severity is low, many people have adopted a “no test, no stress” attitude, especially in light of the potential personal disruption that COVID infection causes. It’s a dangerous direction and one of the reasons why we will continue to see cases spike.

For communicators to overcome the twin challenges of infection risk perception and status aversion, they must use convert communicators – people who are credible to specific audiences and have changed their views to support disease intervention. There is mounting data showing that people who identified as Republicans were far likelier to get infected by COVID and die from the disease than those from left-leaning political parties. Messaging that taps into this research could point to breaking through to these audiences.

Successful public health interventions rely on a strong majority of the population participating in disease mitigation efforts, which means spotlighting conservative voters who see the value of COVID testing and can serve as credible messengers to similarly ideologically inclined individuals. This is where digital storytelling, data visualization and engagement of champions outside of the health sector can be potent measures to build the case for supporting new public health tools.   

It is also important to truly understand the pain points that different audience segments cite as reasons for not wanting to know their infection status and to provide targeted counterpoints. Most people can’t afford to miss work, even with a mild case, and families can be heavily impacted when a parent must choose between going to work or keeping their kids home. In these and other scenarios, the test result becomes the thing people may begin to dread more than the disease itself.

To ensure that people do not feel like they must choose between a host of the least bad options when COVID comes to their home, the government must consider new incentives for reporting positive test results and adhering to public health guidelines. These can range from reinstituting protected sick leave that was available as part of the Families First Coronavirus Response Act (FFCRA) during the pandemic to encouraging more employers to use the tax credits available through the American Recovery Plan Act (ARPA) to reimburse for employee sick leave. Without putting these and other options on the table, people will feel penalized even when they do the right thing.

The post It’s Time to Up Our Messaging Game Ahead of Another Winter with COVID appeared first on Medika Life.

It is hard now to worry when Texas Covid cases look like this:

I know I am not alone. Every day at least one friend sends me a text message asking how to get a Covid test. Home testing is an easy solution to help people decide if they can go to work or take the kids to school. Home Covid tests also give us the peace of mind to know we are not carrying the virus.  

The BinaxNOW Covid-19 Antigen Card offered by Abbott labs is an at-home test available for purchase at most pharmacies. My fully-vaxxed family keeps one box at home at all times to help us make responsible decisions. We want to stay safe, but we want to ensure we do not infect anyone else if we contract the virus. 

The most important action we can take to stay safe and to protect others is to get a vaccine against Covid-19. But as Covid cases surge across the US, breakthrough cases will occur. A breakthrough case is when someone who has already been vaccinated tests positive for Covid-19. 

To slow the spread of Covid-19, protect others, and prevent the emergence of new variants, we must use all the tools in our toolbelt. Accurate, rapid home tests provide reliable results as fast as possible to help us keep our businesses open, reopen schools and help fight the pandemic spread.

BinaxNow is a step in the right direction.

In scientific terms, the BinaxNow test is a lateral flow immunoassay that detects the nucleocapsid protein antigen from SARS-CoV-2. In simples terms, it works like a home pregnancy test. 

This test is approved for symptomatic and asymptomatic people under an FDA Emergency Use Authorization. Anyone can use this test at home and get reliable results within 15 minutes. 

Prices vary depending on the store. I found them for $19 at Walmart and $23 at CVS and Walgreens.

Here are the valuable BinaxNow features:

1. Fast results. Abbott’s rapid antigen test provides results within 15 minutes.
2. Accurate results. The test is highly accurate when testing symptomatic patients within seven days of the onset of symptoms. The data reported to the FDA shows a sensitivity of 97.1% and a specificity of 98.5% among people who have symptoms of Covid-19. 
3. Pain-free nasal swab. This technology does not require the tickle-your-brain deep nasopharyngeal swab like the PCR tests. A simple, painless nose swab is used to collect the testing specimen about 1/2 inch into the nostril.
4. Users may choose to upload the results to the Navica app to meet international travel requirements. 

BinaxNow can detect multiple variants of Covid-19, including the delta variant. The company website reports, “ Abbot conducted a computational analysis of the detection of multiple SARS-COV-2 strains, including the Delta variant, and predicts no impact to the performance of our BinaxNOW™ COVID-19 Antigen Self Test.”

The test results will show as positive or negative. BinaxNow will not determine which variant is causing the positive result.

What Covid-19 tests are available now?

There are three categories of Covid-19 tests. Each works in different ways to detect evidence of SARS-CoV-2 infection.

1. Antibody testing detects a past infection and potential immunity. People developed antibodies after natural Covid infection or after immunization. 
2. Molecular testing(PCR) detects genetic material from the virus to determine if someone has the virus right now. PCR testing is the gold standard of testing. 
3. Antigen testing detects the fragmented pieces of the virus that trigger an immune response. Like PCR testing, antigen testing is used to detect an active infection but can be done much faster. 

BinaxNow uses antigen detection. Antigen testing is less accurate than PCR testing. Antigen tests look for pieces of the virus. They are less accurate than traditional molecular PCR testing, which looks for the virus’s genetic material.

The test offers tremendous value because it can be done at home without having to go to a doctor, hospital, or lab. With results available in 15 minutes, families can make real-time decisions regarding their behavior.

The recommendation is to repeat the BinaxNow test after 36 hours. This dual testing strategy helps overcome the slightly lower detection rate of antigen testing over PCR testing. Each testing kit comes with two tests to make the process easy. 

How do you perform a BinaxNow home Covid test?

Instructions for use:

1. Wash and dry your hands. 
2. Take one test, one bottle, one swab, and the 15-minute timer.
3. Lay the card flat on a table. 
4. Verify there is a blue line in the control line of the results window to verify the test is functional 
5. Open the test card and avoid touching the test strip. 
6. Place six drops from the dropper bottle into the top hole.
7. Collect the samples by inserting the swab 1/2 inch into the nostril, making five circles over 15 seconds. Repeat the process in the other nostril.
8. Insert the swab tip into the second hole and slide up until you see the swab tip in the first hole. Make three clockwise circles and leave the swab in place while the test performs.

9. Close the test card and press down on the right edge to seal it.

10. Wait 15 minutes to check the results. 

A positive result will have two lines and look like this example taken from the company website. 

We all must do our part to help protect ourselves and others. Every person can help slow the spread by taking practical steps to protect themselves and others. 

Getting vaccinated is the most effective way to keep yourself safe. For those who do not believe they need a Covid-19 vaccine for their protection, we ask you to get a vaccine to protect others and prevent the emergence of new dangerous variants. 

A virus that can not spread can not mutate. Children who are too young to get a vaccine and immunocompromised people need your help. Wearing a mask and washing our hands are two other tools we can use to slow the spread.

Home Antigen testing is an excellent option to help us assess our risk. Anytime we have symptoms, we can get accurate results in 15 minutes. These tests help us make real-time decisions about going to work or sending our children to school.

The post How Do You Do a Test at Home for COVID-19 and Is BinaxNow Worth the Money? appeared first on Medika Life.

Dr. Gerardine Gerri Botte, a professor of chemical engineering at Texas Tech University’s Edward E. Whitacre Jr. College of Engineering, announced UFC-19, an ultra-fast Covid-19 detection sensor. This test can detect the presence of the SARS-CoV-2 virus in saliva in 100 milliseconds.

The product developed results from a partnership between Texas Tech faculty research and the university’s entrepreneurial program accessible through Texas Tech’s Innovation Hub at Research Park.

The Innovation Hub is a resource within Texas Tech designed to nurture budding entrepreneurs. Students and faculty can tap the available resources for funding and mentorship. The 40,000 square-foot Innovation Hub helps entrepreneurs form new technology startup companies.

Dr. Gerardine Gerri Botte. Dr. Botte used her expertise in chemical engineering to found a biotech company called EviroTech. She joined the Texas Tech Division of Chemical Engineering in 2019. She has extensive research experience and is an entrepreneur.

Evirotech, in partnership with the Innovation Hub, received working capital from the Department of Defense and other sources such as the Prototype Fund, Presidents’ Innovation Award, and the National Science Foundation’s I-Corps program. The Defense Advanced Research Projects Agency (DARPA) works with the Department of Defense (DoD) “to make pivotal investments in breakthrough technologies for national security.”

Evirontech patented the technology. The company has applied to the US Food and Drug Administration for Emergency Use Authorization (EUA). If approved, people would have the option of rapid home testing that can sync directly to their phones. An accurate, easy-to-use home test will help people make safety decisions for themselves and their families.

EviroTech announced a four-million-dollar investment from German company 1701 Ventures GmbH to help the project get off the ground. This capital will allow EviroTech to begin production and distribution.

Scaling up rapid and frequent testing may be one of the tools the world needs to reopen fully. Covid-19 vaccines and immunity from natural infection have made a significant dent in Covid-19 cases. Texas has confirmed almost 2.5 million cases so far and currently is averaging about 1000 cases per day. At the same time, the rise of Covid-19 variants rages out of control in India and Brazil.

Covid testing has slowed in Texas, but it remains a crucial element in our fight against the pandemic. Testing allows doctors to diagnose and treat those who have Covid-19. Testing enables health workers to do contact tracing and find others who may have been exposed. Testing with genetic sequencing provides information to the public health system to track trends in specific communities.

University researchers across Texas have provided crucial data and cutting-edge innovations to assist public health experts in the fight against Covid-19.

Researchers at Texas A&M University recently identified a new Covid-19 variant called BV-1 by performing genetic sequencing on Covid strains from severe, mild, and asymptomatic infections. UT Southwestern genetic scientists in Dallas identified the first North Texas case of the Brazil P.1 Covid-19.

Texas Tech University’s collaboration to create the UFC-19 Ultra-fast Covid-19 detection sensor could be a way for public health experts to track the prevalence of the disease going forward. The ultra-fast COVID-19 sensor is an antigen-based electrochemical device. Antigen testing detects SARS-CoV-2 spike proteins at an early stage of infection.

Antigen testing is less expensive than PCR tests. It also detects active disease, unlike antibody tests which show evidence of a past Covid-19 infection. The UFC-19 Ultra Fast antigen detection sensor uses saliva instead of a deep sala swab.

A negative antigen test is slightly less accurate than a PCR test, but antigen testing is highly accurate at detecting if someone has an active COVID-19 infection. Antigen testing can also be performed as a point-of-care test. The UFC-19 Ultra Fast test results are available in 100 milliseconds.

The CDC has provided guidance on how to interpret rapid antigen testing.

As the US economy reopens, a scalable, rapid-testing solution could help schools, summer camps, airports, concert venues, and other public gatherings get back to normal. Individuals would have the ability to test themselves at home to detect an early, asymptomatic SARS-CoV-2 infection and prevent spreading the disease.

The UFC-19 Ultra Fast test requires only the detection sensor, a drop of saliva, and a cell phone. An individual would have the test results in seconds.

Take a tour of the Texas Tech Innovation Hub at Research Park here.

The post Texas Tech Professor Invents Game-Changing Ultra Rapid Covid-19 Sensor appeared first on Medika Life.

This article will explain, at length, in both plain English and in more scientific language, how the test works, the different types of tests and it will discuss at length, reliability.

A quick history

Often heralded as one of the most important scientific advances in molecular biology, PCR revolutionized the study of DNA to such an extent that its creator, Kary B. Mullis, was awarded the Nobel Prize for Chemistry in 1993. The link leads to a short, but fantastic biography of his life and offers deep insights into the man, I highly recommend reading it.

Once amplified, the DNA produced by PCR can be used in many different laboratory procedures. For example, most mapping techniques in the Human Genome Project (HGP) relied on PCR.

PCR is also valuable in a number of laboratory and clinical techniques, including DNA fingerprinting, detection of bacteria or viruses (particularly AIDS), and diagnosis of genetic disorders.

The process that underpins PCR was first discovered by Mullis in 1985. Surprised? It’s been around a long time and over the course of the last 36 years, science has had the opportunity to refine and improve on it, over numerous iterations, to the point where we can now quickly and accurately produce millions of copies from a small DNA sample to enable various tests. 

Unsurprisingly, most people were blissfully unaware of the test until the pandemic arrived in 2020. It’s taken a year and no formal training to turn the entire planet into PCR experts. Let’s get to grips first with the terminology used to discuss PCR.

Your Personal PCR Dictionary

This list will provide all the terms you need to enable you to follow the more technical aspects below. Do refer back to it if you get lost further into the article and don’t be put off by the technical bits. The process itself is really simple. Some of the terms below do not apply directly to PCR but have been included to provide a clearer understanding of the differences between PCT and Serum (blood) based tests.

DNA

Deoxyribonucleic acid, more commonly known as DNA, is a complex molecule that contains all of the information necessary to build and maintain an organism. All living things have DNA within their cells. In fact, nearly every cell in a multicellular organism (like us) possesses the full set of DNA required for that organism. DNA contains our hereditary material and our genes — it’s what makes us unique.

cDNA

cDNA, called complementary DNA,is a copy of DNA that can be derived from either prokaryotes or eukaryotes. It is used in genetic engineering to produce clones of other genes. cDNA is synthesized from mRNA using an enzyme called reverse transcriptase. The RT-PCR test uses RNA which it converts into cDNA for testing.

RNA, mRNA, and tRNA

The main function of RNA is to carry information of amino acid sequence from the genes to where proteins are assembled on ribosomes in the cytoplasm. This is done by messenger RNA (mRNA). A single strand of DNA is the blueprint for the mRNA which is transcribed from that DNA strand. More specifically, messenger RNA (mRNA) carries the protein blueprint from a cell’s DNA to its ribosomes, which are the “machines” that drive protein synthesis. Transfer RNA (tRNA) then carries the appropriate amino acids into the ribosome for inclusion in the new protein.

Template

Where you see this term in relation to PCR tests, it refers to the materials you provide via a swab test, in other words, your genetic material and if you’re infected, the virus’s genetic material. This is used as a template (the original from which copies are produced) for the PCR tests.

PCR

Also referred to as “molecular photocopying,” the polymerase chain reaction (PCR) is a fast and inexpensive technique used to “amplify”(copy) small segments of DNA. Because significant amounts of a sample of DNA are necessary for molecular and genetic analyses, studies of isolated pieces of DNA are nearly impossible without PCR amplification¹.

RT-PCR

Reverse transcription PCR, or RT-PCR, allows for the use of RNA as a template. An additional step allows the detection and amplification of RNA. The RNA is reverse transcribed into complementary DNA (cDNA), using reverse transcriptase (RT). The quality and purity of the RNA template is essential for the success of RT-PCR

qPCR and RT-qPCR

A real-time PCR, also known as quantitative Polymerase Chain Reaction, is a laboratory technique of molecular biology based on the polymerase chain reaction. It monitors the amplification of a targeted DNA molecule during the PCR, not at its end, as in conventional PCR. RT-PCR is for amplification, while qPCR is for quantification.

In RT–qPCR, RNA transcripts are quantified by reverse transcribing them into cDNA first, as described above and then qPCR is subsequently carried out. qPCR plays an important role in the detection, quantification, and typing of viral pathogens. This is because detection of important clinical and veterinary viruses using culture methods is time-consuming or impossible, while ELISA tests are not universally available and suffer from comparatively low sensitivity and specificity.

Real Time RT-PCR or Real Time PCR (again, for clarity)

RT–PCR, as we now know, is a variation of PCR. The two techniques use the same process except that RT–PCR has an added step of reverse transcription of RNA to DNA, or RT, to allow for amplification. PCR is used for pathogens, such as viruses and bacteria, that already contain DNA for amplification, whereas RT–PCR is used for those containing RNA that needs to be transcribed to DNA for amplification. 

Both techniques can be performed in ‘real time’, which means results are visible via fluorescent markers almost immediately, Conventional PCR and RT-PCR results are only visible at the end of the reaction.

Taq DNA polymerase

When most organisms go above 130 degrees, the proteins in their cells change structure so that they become non-functional, similarly to how the protein in egg white changes when you cook it. Because proteins do almost everything that gets done in our cells, high temperatures are usually fatal.

Because of the higher temperatures required for denaturation DNA Polymerase is not suitable for Polymerase Chain Reaction (PCR) tests. Taq DNA Polymerase, on the other hand, plays an essential role in PCR. Taq DNA Polymerase is a highly thermostable recombinant DNA polymerase. It is named after Thermus aquaticus, the heat-tolerant bacterium from which it isolates itself. It is able to tolerate the heat required for the denaturation process in PCR.

Thermocycler

The machine that runs the actual PCR test. It works by heating and then cooling the DNA sample to allow the DNA sample to be broken apart (denatured) and then reformed(synthesis). Think of it as a biological actual xerox machine and your DNA is the white sheet of paper being copied.

Denature

In biology, this process describes modifying the molecular structure of a protein. Denaturation involves the breaking of many of the weak linkages, or bonds (e.g., hydrogen bonds), within a protein molecule that are responsible for the highly ordered structure of the protein in its natural (native) state. In the PCR test, heat is used to denature DNA, in other words, to separate the two combined strands of DNA

Serological Tests

Serologic tests are blood tests that look for antibodies in your blood. They can involve a number of laboratory techniques. Different types of serologic tests are used to diagnose various disease conditions. Serologic tests have one thing in common. They all focus on proteins made by your immune system. These tests offer an alternative to PCR tests.

Assay or Bioassay

Wondered about this term? A bioassay or biological assay is a biological testing procedure for estimating the concentration of a pharmaceutically active substance in a formulated product or bulk material. In contrast to common physical or chemical methods, a bioassay results in detailed information on the biological activity of a substance. 

Antibodies

We’ll explain anyway, although we doubt anyone, anywhere on the planet, doesn’t know by now what antibodies are. Antibody, also called immunoglobulin, is a protective protein produced by the immune system in response to the presence of foreign substances, called antigens. Antibodies recognize and latch onto antigens in order to remove them from the body.

They don’t always protect though. Antibodies that recognize the body’s own proteins, instead of proteins from infectious microbes, can cause harm. In autoimmune diseases, such as lupus, multiple sclerosis and rheumatoid arthritis, people produce antibodies that stick to their body’s own proteins and attack healthy cells.

Serum or Plasma Sample

Serum is the liquid portion of the blood obtained after a serum sample tube has been allowed to clot and is centrifuged. You need 12 mL of whole blood for each 5 mL of serum or plasma. Blood s collected in an appropriate collection tube and placed in a centrifuge for at least 15 minutes at 2200–2500 RPM.

Seropositive

The state of either having or not having detectable antibodies against a specific antigen, as measured by a blood test (serologic test). For example, HIV seropositive means that a person has detectable antibodies to HIV; seronegative means that a person does not have detectable HIV antibodies. Interestingly, new HIV antivirals are so effective that an HIV-positive person will have no detectable antibodies if tested. This means that although they remain HIV-positive, they can no longer transmit the disease while they are on the antiviral medication.

ELISA

ELISA (enzyme-linked immunosorbent assay) is a plate-based assay technique designed for detecting and quantifying soluble substances such as peptides, proteins, antibodies, and hormones. Other names, such as enzyme immunoassay (EIA), are also used to describe the same technology. Some examples include diagnosis of HIV infection, pregnancy tests, and measurement of cytokines or soluble receptors in cell supernatant or serum.

How does PCR work?

To amplify a segment of DNA using PCR, the sample is first heated so the DNA denatures, or separates into two pieces of single-stranded DNA. Next, an enzyme called “Taq polymerase” synthesizes (builds ) two new strands of DNA, using the original strands as templates. This process results in the duplication of the original DNA, with each of the new molecules containing one old and one new strand of DNA. 

Then each of these strands can be used to create two new copies, and so on, and so on. The cycle of denaturing and synthesizing new DNA is repeated as many as 30 or 40 times, leading to more than one billion exact copies of the original DNA segment. 

The entire cycling process of PCR is automated and can be completed in just a few hours. It is directed by a machine called a thermocycler, which is programmed to alter the temperature of the reaction every few minutes to allow DNA denaturing and synthesis.

There are many different PCR tests made by different manufacturers and each test is unique in its own way, requiring different cycles and temperatures, depending on the manufacturer’s instruction, to function effectively. It is critical that laboratories follow these instructions to ensure the tests return accurate results.

Understanding how PCR detects the coronavirus

PCR is highly sensitive and requires minimal template (your sample) for detection and amplification of specific sequences. At the moment the majority of the current Covid-19 tests are using PCR². They detect the genetic information of the virus, the RNA. That’s only possible if the virus is there and someone is actively infected.

PCR tests are used to directly detect the presence of an antigen, rather than the presence of the body’s immune response, or antibodies. By detecting viral RNA, which will be present in the body before antibodies form or symptoms of the disease are present, the tests can tell whether or not someone has the virus very early on. The PCR test doesn’t depend on finding an immune response in the form of an antibody.

Blood tests would typically check for the antibody, in other words, the body’s response to being infected. PCR tests are therefore able to pick up infected individuals far earlier than traditional serum-based tests. It takes a few days for your body to start producing antibodies in response to the antigen. 

The presence of the antigen is, however, immediately detectable with PCR, particularly as swabs are taken from the virus’s ingress point into the body, the nasopharyngeal area.

The contribution PCR makes to immediate detection, isolation, and contact tracing in the midst of a pandemic can not be overstressed. Correctly used, PCR in conjunction with policies to identify and isolate early outbreaks, leads to early containment. Asian countries are the perfect example of the efficacy of this strategy in combatting a viral outbreak.

America sadly portrays the effects of ignoring early warning signs and not taking aggressive and offensive action at the outset of the pandemic.

How is Real Time RT–PCR used?

Real time RT–PCR is a nuclear-derived method for detecting the presence of specific genetic material in any pathogen, including a virus. Originally, the method used radioactive isotope markers to detect targeted genetic materials, but subsequent refining has led to the replacement of isotopic labeling with special markers, most frequently fluorescent dyes. This technique allows scientists to see the results almost immediately while the process is still ongoing, whereas conventional RT–PCR only provides results at the end of the process.

Real time RT–PCR is one of the most widely used laboratory methods for detecting the COVID-19 virus. While many countries have used real time RT–PCR for diagnosing other diseases, such as the Ebola virus and Zika virus, many have needed support in adapting this method for the COVID-19 virus, as well as in increasing their national testing capacities. 

Here is an example of the CDC-recommended kit and if you’re wondering about how these are used, you can find the instructions for usage here

The exact process involved in Real-Time RT-PCR³

A sample is collected from the parts of the body where the COVID-19 virus gathers, such as a person’s nose or throat. The sample is treated with several chemical solutions that remove substances such as proteins and fats and that extract only the RNA present in the sample. This extracted RNA is a mix of your genetic material and, if present, the virus’s RNA.

The RNA is reverse transcribed to cDNA using a specific enzyme. Scientists then add additional short fragments of DNA that are complementary to specific parts of the transcribed viral DNA. If the virus is present in a sample, these fragments attach themselves to target sections of the viral DNA. 

Some of the added genetic fragments are used for building DNA strands during amplification, while the others are used for building the DNA and adding marker labels to the strands, which are then used to detect the virus.

The mixture is then placed in an RT–PCR machine. The machine cycles through temperatures that heat and cool the mixture to trigger specific chemical reactions that create new, identical copies of the target sections of viral DNA. The cycle is repeated over and over to continue copying the target sections of viral DNA. 

Each cycle doubles the previous number: two copies become four, four copies become eight, and so on. A standard real time RT–PCR set-up usually goes through 35 cycles, which means that, by the end of the process, around 35 billion new copies of the sections of viral DNA are created from each strand of the virus present in the sample.

As new copies of the viral DNA sections are built, the marker labels attach to the DNA strands and then release a fluorescent dye, which is measured by the machine’s computer and presented in real-time on the screen. The computer tracks the amount of fluorescence in the sample after each cycle. When a certain level of fluorescence is surpassed, this confirms that the virus is present. Scientists also monitor how many cycles it takes to reach this level in order to estimate the severity of the infection: the fewer the cycles, the more severe the viral infection is.

This key difference of enabling an assessment of the severity of the infection is one of the key benefits of using real time RT-PCR testing over conventional PCR.

Is it foolproof?

There is a flaw, however, that exists in these tests, not because of PCR, but rather as a result of human error. 

It is possible for a nasopharyngeal swab sample to be taken from an area that does not contain the antigen (virus), despite the person being infected with the SARS-CoV2 virus. In this instance, the test will return a negative result. The test is not wrong, it is dependent on the quality and integrity of the sample provided.

PCR tests can also be very labor-intensive, with several stages at which errors may occur between sampling and analysis. As a result, false negatives can occur up to 30% of the time with different PCR tests, meaning they’re more useful for confirming the presence of infection than giving a patient the all-clear. 

Again, much of this can be ascribed to human error rather than flaws in the test itself.

So just how reliable are PCR tests?

Aah, the million-dollar question, and we don’t have a fixed number answer for you. It isn’t that simple. The answer to this should be provided by data obtained prior to the pandemic and that is not subject to conjecture relating to any covid agendas. This data exists in reams, despite Google’s insistence on placing 30 pages of pandemic-based data and some very questionable articles in front of you. It requires a deep dive and few are willing to go there. 

If PCR is shown to work with a reasonably high degree of success, prior to the pandemic, you’ll agree there is no reason to assume PCR suddenly stopped working simply because of the coronavirus? That’s a logic bump that not even Covid doubters can cross. 

We’ve tried to paint as honest an image of the technology as possible, and below this, we discuss known factors that do affect current covid testing. The next section is complicated and you can skip over it if you prefer as it is not integral to understanding published results. To understand how the reliability, sensitivity, and accuracy of PCR assays are gauged we need to explore a few concepts to help clarify why a simple 90/100 answer can not be provided.

Analytical Sensitivity (Limit of Detection, LOD and Limit of Quantification, LOQ)

Probit or Logit approaches are preferred for determining the LOD for PCR methods. Briefly, both mathematical functions are regressions used to analyze binomial response variables (positive or negative) and are able to transform the sigmoid dose-response curve, typical of a binomial variable, to a straight line that can then be analyzed by regression either through least squares or maximum likelihood methods. 

The final end-point of the analysis is a concentration (coupled with relative intervals of confidence), associated to a probability (e.g., 95%) to detect the nucleic acid. Moreover, Probit regression is exploitable only for normally distributed data, while Logit function can also be used for data not normally distributed; however, in this context, both functions have the same meaning.

An issue that must be addressed for the determination of the Limit of Quantification(LOQ), as well as LOD, is the efficiency of recovery of target molecules during the nucleic acid extraction phases. Generally, nucleic acids are extracted from different complex matrices, like food, feces, or other samples using different procedures. The efficiency of DNA recovery is usually around 30% and lower and neglecting this parameter leads to underestimation of the true number of target microorganisms in the original sample, which is then reflected by the lower LOD and LOQ values. 

Therefore, the determination of DNA isolation efficiency should be part of the LOD and LOQ. DNA isolation efficiency is a quotient between the number of microorganisms recovered after the entire procedure (nucleic acid extraction + qPCR) and the number of microorganisms used for spiking the negative matrices.

There are various other mechanisms used to determine the specificity of PCR and these are bound to the type of assay and the endpoint. As an example, here are specifics from tests performed on the Intellicube from Douglas Scientific, dating back to 2014.

The IntelliQube is a fully integrated liquid handling and real-time quantitative PCR (qPCR) instrument optimized for use with miniaturized reactions in 768-well Array Tape®. We evaluated the technical performance of the IntelliQube with human genomic DNA, calibrated against the National Institute of Standards and Technology (NIST) standard reference material (SRM), and measured with the ValidPrime human genome specific assay. In this study, we estimated the limit of detection (LoD), limit of quantification (LoQ) and PCR efficiency. The LoD was three molecules, which corresponds to the theoretical sensitivity limited by sampling ambiguity. LoQ, corresponding to a relative standard deviation of 35%, was 32 molecules, and PCR efficiency was 99.7% (95% confidence range: 97.7–101.6%). The sensitivity of the instrument was tested using a digital PCR setup. When loading an average of two molecules per well, we recovered 1.96 (95% confidence range: 1.80–2.15) molecules. A small loss was observed when loading an average of one molecule per well. Taken together, these data are evidence of excellent performance with a technical error negligible relative to the sampling error, virtually perfect PCR under optimum conditions, and a sensitivity to detect one to two template molecules per well.

Real time PCR for identifying Visceral Leishmaniasis (VL)

This simple example illustrates the efficacy of PCR, particularly real time PCR, PCR technology has been significantly refined, and real-time PCR now has advantages over traditional PCR, with shorter run times (because electrophoresis is no longer required) and reduced risk of contamination (because amplification can be detected while the tube is still closed).

PCR for the detection of parasite DNA in peripheral blood is a non-invasive alternative for diagnosis, especially when the disease is suspected in patients with negative parasitological results. in a paper entitled, ‘Sensitivity of PCR and real-time PCR for the diagnosis of human visceral leishmaniasis using peripheral blood’ the authors noted the following.

• real-time PCR using the RV1/RV2 primers exhibited higher discriminative power, a feature that corroborates its advantages over the other techniques investigated
• Real-time PCR was the only technique able to provide positive diagnoses for two of the patients, corroborating the advantages of applying this technique with RV1/RV2 primers for VL diagnosis
• Real-time PCR was sufficiently sensitive to detect as little as 0.001 parasite per reaction using TaqMan probes in human blood samples. A slope of -3.3 corresponds to an efficiency of 100.0%, indicating that the number of amplified molecules doubles with each cycle of PCR. In this study a slope of -3.06 was obtained, demonstrating high efficiency.
• A real-time PCR system with SYBR green was used for the diagnosis of cutaneous leishmaniasis using skin biopsy samples from 100 patients. This technique was found to be more sensitive than microscopy and culture methods.

Medical literature is filled with similar papers pre-pandemic, confirming the efficacy of PCR. Obviously, no medical test is foolproof and depending on the antigen we are testing for, various factors can affect the results we achieve using PCR. To suggest however that the test is hopelessly flawed and not suited to identifying the SARS-CoV2 virus is complete lunacy and not based in reality.

It is clear however that the reliability of the PCR test itself is dependant on various factors.

• Human error in collecting and handling samples. Tardy delivery and lax protocols regarding samples, failure to follow specific PCR instructions on different tests, and other issues can and do affect results.
• Some doubt exists as to the best areas to swab for SARS-CoV2. A study has reported sputum as the most accurate sample for laboratory diagnosis of COVID-19, followed by nasal swabs, while throat swabs were not recommended for the diagnosis.⁴
• False-negative results may occur by mutations in the primer and probe-target regions in the SARS-CoV-2 genome. Variability causing mismatches between the primers and probes and the target sequences can lead to a decrease in assay performance and potential false-negative results. In this regard, multiple target gene amplification could be used to avoid invalid results.⁵
• Different viral load kinetics of SARS-CoV2 in different patients suggest that sampling timing and period of the disease development play an important role in real-time RT-PCR results.

The Centers for Disease Control and Prevention (CDC) has designed a SARS-CoV-2 Real-Time RT-PCR Diagnostic Panel⁶ to minimize the chance of false-positive results. It is the same test referenced earlier in the article. The efficacy of this test is, again, dependent on qualified laboratory staff and following the recommended protocols.

It’s important to note that most literature points predominantly to the risks of false-negatives, rather than false-positives. While false-positives do occur they are outweighed by tests that actually miss the virus. This is completely at odds with the fanciful narrative the conspiracy theorists would have you believe, namely that all the positive cases identified are as a result of the tests being manipulated.

The invention of PCR has greatly boosted research in various areas of biology and this technology has significantly contributed to the current level of human knowledge in many spheres of research.

Why Medika Life wrote this article

PCR testing has become the poster child of Covid conspiracy theorists. It’s their defacto fallback when launching an attack on the very real dangers the coronavirus poses. If they attended rallies, probably next on their twisted to-do lists, PCR slogans would adorn their billboards and T-shirts.

Now while we realize that the anti-vaxxers, conspiracy, and anti-covid clans are for the most part indistinguishable and driven by the same misguided psychology, they nonetheless pose a risk to public health and must be addressed.

Their tactics are simple. Like a circling pack of hyenas, they will identify the weakest member in their targeted group and focus their attack on that individual. In the world of Covid, they seem, for some unfathomable reason to have settled on the PCR test.

I say unfathomable because the PCR test is in fact not the weakest link in the pandemic chain. Not by a long shot. It does however suffer from a critical flaw they’ve exploited. It is complicated. It is also prone to human error, but not in the way they would have you believe. It is more likely to return a false negative than a false positive result

To understand exactly how PCR tests work, you need, if you are a layman, to do a reasonably deep dive into the scientific world to form an understanding of the mechanisms and reliability of the process. Most people don’t and it’s for this reason the test has been earmarked.

It’s easy to discredit PCR with an article composed of a few pages of pseudo-scientific mumbo jumbo and the average reader would be none the wiser. The scientist would see through the lies and the intelligent reader would seek alternate reliable sources to validate the article.

As the pandemic has progressed, the term ‘reliable’ has become vague. Real science, evidence-based, tried and tested data, has become something of a rare beast. Hard to find, amidst the sea of misinformation and conspiracy-driven drivel that floods the digital world.

If we publish an article discrediting conspiracy theorists, the author’s defenders go for the jugular, using their tool of choice. The PCR test. It’s their absolute favorite and they will quote all sorts of nonsense or take existing science and misinterpret it to the point it becomes unrecognizable.

So, rather than waste hours of precious time answering these misguided souls, we chose to write this article to explain, in plain English, why PCR tests are in fact, extremely reliable.

References

1. Polymerase Chain Reaction (PCR) Fact Sheet, NIH, National Human Genome Research Institute
2. What are the differences between PCR, RT-PCR, qPCR, and RT-qPCR? Enzo Life Sciences, 2017 
3. How is the COVID-19 Virus Detected using Real Time RT-PCR? International Atomic Energy Agency, March 2020
4. Yang Y, Yang M, Shen C, et al. Laboratory diagnosis and monitoring the viral shedding of 2019-nCoV infections. medRxiv preprint. DOI:10.1101/2020.02.11.20021493. [CrossRef] [Google Scholar]
5. Kim JY, Ko JH, Kim Y, et al. Viral Load Kinetics of SARS-CoV-2 infection in first two patients in Korea. J Korean Med Sci. 2020. February 24;35(7):e86. . [PMC free article] [PubMed] [Google Scholar]
6. [Cited 2021 Mar 25;]. https://www.cdc.gov/coronavirus/2019-ncov/lab/rt-pcr-detection-instructions.html

The post The Complete Dummies Guide to Covid PCR Testing for Conspiracy Fans appeared first on Medika Life.

• Abbott’s BinaxNOW™ COVID-19 Ag Card is a rapid, reliable, highly portable, and affordable tool for detecting active coronavirus infections at massive scale.
• Test delivers results in just 15 minutes with no instrumentation, using proven lateral flow technology with demonstrated sensitivity of 97.1% and specificity of 98.5% in clinical study.
• Abbott to offer a no-charge complementary phone app, which allows people to display their BinaxNOW test results when asked by organizations where people gather, such as workplaces and schools.
• Company will ship tens of millions of tests in September, ramping to 50 million tests a month at the beginning of October.

DATE OF RELEASE: Aug. 26, 2020 

ABBOTT PARK, Ill/ — Abbott (NYSE: ABT) announced today that the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for its BinaxNOW™ COVID-19 Ag Card rapid test for detection of COVID-19 infection. Abbott will sell this test for $5. It is highly portable (about the size of a credit card), affordable and provides results in 15 minutes. BinaxNOW uses proven Abbott lateral flow technology, making it a reliable and familiar format for frequent mass testing through their healthcare provider. With no equipment required, the device will be an important tool to manage risk by quickly identifying infectious people so they don’t spread the disease to others.

Abbott will also launch a complementary mobile app for iPhone and Android devices named NAVICA™. This first-of-its-kind app, available at no charge, will allow people who test negative to display a temporary digital health pass that is renewed each time a person is tested through their healthcare provider together with the date of the test result. Organizations will be able to view and verify the information on a mobile device to facilitate entry into facilities along with hand-washing, social distancing, enhanced cleaning and mask-wearing.

“We intentionally designed the BinaxNOW test and NAVICA app so we could offer a comprehensive testing solution to help Americans feel more confident about their health and lives,” said Robert B. Ford, president and chief executive officer, Abbott. “BinaxNOW and the NAVICA app give us an affordable, easy-to-use, scalable test, and a complementary digital health tool to help us have a bit more normalcy in our daily lives.”

In data submitted to the FDA from a clinical study conducted by Abbott with several leading U.S. research universities, the BinaxNOW COVID-19 Ag Card demonstrated sensitivity of 97.1% (positive percent agreement) and specificity of 98.5% (negative percent agreement) in patients suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset.

“The massive scale of this test and app will allow tens of millions of people to have access to rapid and reliable testing,” said Joseph Petrosino, Ph.D., professor and chairman, Molecular Virology and Microbiology, Baylor College of Medicine, whose labs have been leading efforts to provide COVID-19 testing for the college and Harris County. “With lab-based tests, you get excellent sensitivity but might have to wait days or longer to get the results. With a rapid antigen test, you get a result right away, getting infectious people off the streets and into quarantine so they don’t spread the virus.”

Under FDA EUA, the BinaxNOW COVID-19 Ag Card is for use by healthcare professionals and can be used in point-of-care settings that are qualified to have the test performed and are operating under a CLIA (Clinical Laboratory Improvement Amendments) Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. Within these settings, the test can be performed by doctors, nurses, school nurses, medical assistants and technicians, pharmacists, employer occupational health specialists, and more with minimal training and a patient prescription.  

“Our nation’s frontline healthcare workers and clinical laboratory personnel have been under siege since the onset of this pandemic,” said Charles Chiu, M.D., Ph.D., professor of Laboratory Medicine at University of California, San Francisco. “The availability of rapid testing for COVID-19 will help support overburdened laboratories, accelerate turnaround times and greatly expand access to people who need it.”

Currently, AdvaMed (The Advanced Medical Technology Association) estimates that test manufacturers are shipping about 1 million tests per day. Abbott will ship tens of millions of tests in September, ramping to 50 million tests a month at the beginning of October. The company has invested hundreds of millions of dollars since April in two new U.S. facilities to manufacture BinaxNOW at massive scale.

The BinaxNOW COVID-19 Ag Card can be used as a first line of defense to identify people who are currently infected and who should isolate themselves to help prevent the spread of the disease. It is intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in nasal swabs from individuals suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset.

As a near-person rapid antigen test, BinaxNOW was engineered for point-of-care settings, near-patient, and not for reference labs. Patient samples should be tested immediately and should not be diluted in viral transport media.

NAVICA mobile app will help facilitate return to daily activities
Abbott is also offering a mobile app at no charge that will allow people to display their results obtained through a healthcare provider when entering facilities requiring proof of testing. The NAVICA app is optional and an easy-to-use tool that allows people to store, access and display their results with organizations that accept the results so people can move about with greater confidence. The app is supported by Apple and Android digital wallets and will be available from public app stores in the U.S.

“While BinaxNOW is the hardware that makes knowing your COVID-19 status possible, the NAVICA app is the digital network that allows people to share that information with those who need to know,” said Ford. “We’re taking our know-how from our digitally-connected medical devices and applying it to our diagnostics at a time when people expect their health information to be digital and readily accessible.”  

If test results are negative, the app will display a digital health pass via a QR code, similar to an airline boarding pass. If test results are positive, people receive a message to quarantine and talk to their doctor. As they’re required to do for all COVID-19 tests, healthcare providers in all settings will be required to report positive results to the CDC and other public health authorities, regardless of whether they use the app. The digital health pass is stored in the app temporarily and expires after the time period specified by organizations that accept the app.

The app’s user interface is supported by a back-end digital infrastructure that is cloud-based, scalable and secure. It’s been designed to support a very large number of users and enable access from anywhere. The app is not for contact tracing and only collects a person’s first and last name, email address, phone number, zip code, date of birth and test results.

About the BinaxNOW COVID-19 Ag Card Test
The BinaxNOW COVID-19 Ag Card is an assay for the qualitative detection of specific antigens to COVID-19 in the human nasal cavity. A simple nasal swab is used to collect specimens from people suspected of having an active infection. No equipment is required to process samples or read test results. In addition, minimal chemical reagents are required, which lessens exposure to biohazardous materials and improves safety for those administering the test.

The BinaxNOW COVID-19 Ag Card is the sixth test that Abbott is launching in the U.S. to help fight the coronavirus pandemic. Abbott’s tests are performed on its high-volume m2000™ and Alinity® m molecular laboratory systems; its ID NOW™ rapid molecular point-of-care platform; antibody tests for its high-throughput ARCHITECT® i1000SR and i2000SR and Alinity™ i laboratory instruments.

Abbott has provided more than 27 million COVID-19 tests in the U.S. to date, including 14 million detection tests and 13 million antibody tests.  

About Abbott
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 107,000 colleagues serve people in more than 160 countries.

Connect with us at www.abbott.com, on LinkedIn at www.linkedin.com/company/abbott-/, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

The BinaxNOW™ COVID-19 Ag Test Card EUA has not been FDA cleared or approved. It has been authorized by the FDA under an emergency use authorization for use by authorized laboratories and patient care settings. The test has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens, and is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

SOURCE Abbott

For further information: Abbott U.S. Media: John Koval, 224-668-5355, Jackie Lustig, 224-668-9857, Darcy Ross, 224-667-3655; For all other countries, see: https://www.abbott.com/corpnewsroom/utilities/media-contacts.html; Abbott Investor Relations: Laura Dauer, 224-667-2299

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DATE OF RELEASE: Jul 24, 2020, 07:30 ET

GLEN ALLEN, Va. /PRNewswire/ — TCA/ GENETWORx Laboratories announced today that it has added substantial testing capacity and is now providing COVID-19 diagnostic test results in 72 hours or less to help battle the surging coronavirus epidemic. TCA/GENETWORx has performed thousands of COVID-19 tests since March and recently experienced some delays, like most other United States laboratories. In order to supply results in 72 hours or less, TCA/GENETWORx invested millions of dollars in real estate and equipment and has recruited hundreds of employees. TCA/GENETWORx is now one of the only companies in America that can confidently deliver COVID-19 test results within 72 hours from receipt of sample.

In partnership with Nucleus, TCA/GENETWORx has also created a test and sample management program called Aura. By having all patients download Aura, TCA/GENETWORx provides patients and customers including healthcare providers, universities, government, assisted living facilities, nursing homes, and other large population organizations a total end to end digital management and medical data system which provides test locations, test scheduling, sample tracking, symptom tracking, contact tracing assistance, dashboard compliance reporting, and government reporting.

Aura expedites turnaround times, reduces laboratory process time, and allows large population customers, including municipalities, state and federal governments, universities, large corporations, and others to manage the COVID-19 compliance and health of their entire workforce, student, and/or patient population.

TCA/GENETWORx has also developed an end to end program to test large inner-city populations in order to greatly reduce testing inequality. According to Brian O’Neill, Chairman of TCI/GENETWORx, this specialized testing for the inner city is desperately needed, “The age-adjusted COVID-19 death rate for African American people is 3.6 times that for whites, and the age-adjusted death rate for Hispanic/Latino people is 2.5 times that for whites. This is unconscionable and we are offering U.S. cities a managed testing solution to address this problem on a large scale.” 

The company is building capability to perform 870,000 tests per day or 26 million per month. In order to meet demand, the company launched a massive recruiting campaign called Re Employ America and is currently extending offers to 50-100 people per day. Moreover, in the company’s Glen Allen, Virginia laboratory, the TCA/GENETWORx “Families Work Here” program employs multiple generations of families. This has instilled an “all hands on deck” culture at the company which has helped it to grow to meet the demand required by the pandemic.

CEO and Co-Founder of GENETWORx William Miller is a member of one of the multi-generational families working together at Genetworx.

“I’m happy to support the U.S. and Virginia economies through our Re Employ America campaign and I’m proud to have members of my family working side by side with me at TCA/GENETWORx to help battle this pandemic,” said Miller.

Another multi-generational family employed by the company includes twenty-year laboratory testing veteran and Chief Laboratory Officer Sarah Jacobs-Helber. “My daughter and my son work here in the medical technology and operations departments. We all feel a tremendous sense of pride that we are contributing in a very real way in our different job roles at Genetworx as we all work together to perform the vital service of testing hundreds of thousands of Americans during this crisis,” she said.

Miller, who cofounded Genetworx in 2013 with two other scientists added “The heart of our lab is full of national pride and that comes from starting out as a smaller lab whose employees really want to make a difference during the country’s infectious disease crisis.”   

Please visit Genetworx.com for further information on hiring or to order testing. To keep up with the latest news about Genetworx, please follow us on Linked In. For media interviews contact: Terri C.Malenfant at tmalenfant@recoverycoa.com.

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We need to talk about what to do if you’ve been in contact with someone with COVID-19 or begin to experience symptoms. Our gut instinct is to run off and get tested. But for the majority of those with viral symptoms, this is the wrong thing to do.

Testing may verify Covid-19, but a positive test for Covid-19 does not change the management. A negative does not change the recommendations either.

When a nonelderly patient without underlying medical conditions or respiratory distress has COVID-19 or has been exposed, the recommendations are home quarantine. Regardless of the test results, the management is two weeks of home isolation and supportive measures such as fluids, rest, and acetaminophen.

Unfortunately, Covid-19 is a new virus for which we don’t have a vaccine, effective medication, or baseline immunity.

What counts as exposure?

You have been exposed after any close contact with anyone who tested positive for COVID-19 or anyone who has symptoms of the disease. According to the CDC close contact means:

• You were within 6 feet of someone who has COVID-19 for at least 15 minutes
• You provided care at home to someone who is sick with COVID-19
• You had direct physical contact with the person (touched, hugged, or kissed them)
• You shared eating or drinking utensils
• They sneezed, coughed, or somehow got respiratory droplets on you

What do you do after an exposure?

Stay home and monitor your health.

• Stay home for 14 days after your last contact with a person who has COVID-19
• You do not need to get tested automatically. You and your doctor should make testing decisions together. After exposure or if you have symptoms, you will be placed on a 14-day quarantine regardless of the test results. Going to get a test exposes you and others to more potential spread. Contact a medical provider to determine if testing is warranted and to make arrangements for testing according to local availability and capacity.
• Watch for fever (100.4◦F), cough, shortness of breath, or other symptoms of COVID-19
• If possible, self-isolate away others, especially people who are at higher risk for getting very sick from COVID-19
• Look for emergency COVID-19 warning signs and seek immediate emergency medical care.
• Communicate with your doctor to evaluate any new onset of symptoms
• Avoid public transportation, ride-sharing, or taxis
• If you become sick, wear a face cover over your nose and mouth if you must be around other people. Masks should not be placed on young children under the age of two.

What are emergency warning signs indicating the need for immediate care?

The CDC provides guidance on when to seek emergency medical attention. If someone shows any of these signs, seek emergency medical care immediately after first calling ahead to let the office or hospital know you are coming.

• Trouble breathing
• Persistent pain or pressure in the chest
• New confusion
• Inability to wake or stay awake
• Bluish lips or face

What do I do if my child has been exposed or has symptoms?

Having a sick child is terrifying for parents. Parents’ first instincts may be to take your child to an Emergency Department to get tested, but management at home is safe in most pediatric cases. The treatment is isolation, fluids, and rest. The concept that testing does not change management is especially challenging when parents are faced with a sick child.

Emergency care is needed if the child shows severe illness symptoms such as high fever or very low body temperature, shortness of breath, fainting, or confusion. If a trip to the emergency department is required, remember to call ahead and let the staff know you are coming.

Otherwise, the child should receive supportive treatment at home. Parents should contact their doctor or pediatrician for advice and continued monitoring of symptoms.

What are the symptoms of COVID-19?

Many patients have no symptoms at all. The safest course of action is for every American to live as though we are asymptomatic carriers. The sad truth is any one of us may be shedding the virus and putting others at risk.

About 80% of COVID-19 cases show mild symptoms or are asymptomatic. Symptoms include typical viral problems such as fever, body aches, dry cough, fatigue, chills, congestion, runny nose, and sore throat.

Many develop gastrointestinal symptoms such as loss of appetite, nausea, vomiting, and diarrhea.

Others develop neurological symptoms such as loss of smell, loss of taste, muscle weakness, numbness, tinglingly in the hands and feet, dizziness, confusion, delirium, seizures, and stroke.

Approximately 20% of COVID-19 patients develop severe symptoms requiring hospitalization. Severe symptoms include high fever, severe cough, shortness of breath, pneumonia, and low blood pressure. Those over age 60 and people with underlying medical conditions such as diabetes, heart disease, respiratory disease, or hypertension are at higher risk of developing severe illness.

The case fatality rate is decreasing, indicating we are getting better at treating those who get sick. But as testing increases around the country, we must remember the positivity rate is also rising. The increase in cases is not due to the increased testing capacity. A higher percentage of people getting tested have the virus.

Recent data from UT Southwestern Medical Center in Dallas shows an increase in admissions of young patients without risk factors. This shift towards the younger and healthier is an important reminder to all of us to continue handwashing, social distancing, and wearing a mask.This Is the Single Easiest Way to Help During the Pandemic.

How do you get tested to know if you have COVID-19 right now?

To detect the virus, a test must be performed to identify viral genetic material. A PCR test, from saliva or a nasal swab, is used to detect the virus’s active presence. There are multiple technologies available in the US, and each has varying degrees of accuracy.

The key thing to know is a positive test is reliable. If a test result comes back positive, it is almost certain that the person has COVID-19. If a test returns a negative result, then you are not off the hook.A negative test does mean you do not have COVID-19.

Regardless of your test results, if you have COVID-like symptoms self-isolate at home, rest, hydrate, and wear a mask when interacting with family members.

If your symptoms do worsen, contact your doctor for further guidance.

How do you get tested to know if you had COVID-19 in the past?

Our bodies develop antibodies after we are exposed to a virus. Antibodies are special proteins our immune system uses to fight infection. We are hopeful that our immense systems will develop neutralizing antibodies to provide long term protection against coronavirus. We have not proven if this is true with COVID-19, but many studies are in progress.

Blood tests can be done to try and detect Coronavirus specific antibodies. Unlike nasal swabs and saliva tests, blood tests are not used to detect active infection. The antibodies do not appear until at least 5–10 days after infection. Antibody testing detects a past infection.

People who have neutralizing antibodies may donate plasma. Antibodies from plasma can be used to treat some patients sick with COVID-19. We are hopeful these antibodies will prove to provide long term immunity.

Each day scientists learn more about this virus. Until we develop a vaccine, effective medication, or a cure, we all must do our part. Social distancing, hand hygiene, and face coverings are our most effective tools to protect ourselves and each other.

These steps may be a small inconvenience, but these minor alterations may potentially save someone else’s life.

We all must do our part.

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