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Updated: Feb 6, 2021

The new SARS-CoV-2 mutant (VOC 202012/01) has become the dominant variant in the United Kingdom (UK) with the first known case in the United States identified on December 29, 2020. Over sixty percent of COVID-19 infections in the UK are now attributed to the new variant. The new variant is defined by 23 mutations, 13 of which are non-synonymous point mutations. In addition, there are 4 deletions and 6 synonymous point mutations.

Viral mutations are not unexpected, this is an unusually large number of mutations in a single cluster. Mutations that enhance the virus’s capacity to spread among people provide a new variant with an advantage over the ancestral strain and enable the new variant to become dominant is its capacity to spread. Commercially available SARS-CoV-2 molecular assays often target the ORF region, as well as genes encoding for envelope protein (E), S and/or nucleoprotein (N). Therefore, the mutations in the new SARS VOC could theoretically impact the accuracy of assays that target ORF8 and S.

The new SARS-CoV-2 variant is detectable by the tests currently offered at BioLabs International.

  • Our high throughput platform (Roche cobas 6800) targets the ORF1ab region and E gene,

  • Our rapid point-of-care platform similarly targets the ORF1ab region, but also detects the N gene.

The selection of ORF1ab and N targets is due to their highly conserved nature (i.e., less likely to mutate) and their unique sequence specific for SARS-CoV-2. In contrast, the use of the E gene serves as a pan-Sarbecovirus marker. It must be noted that N and E mutations do exist but have not increased in prevalence since these variants appear to be no more infectious than non-mutants. Situations may arise where only one out of two targets are detected. Detection of only one gene does not necessarily indicate the presence of a new variant and may be the result of low viral load.

Updated: Jan 17, 2021

What Does That Mean for Vaccines?

As we enter the second year of living with the new coronavirus SARS-CoV-2, the virus is celebrating its invasion of the world’s population with yet more mutated forms that help it to spread more easily from person to person. One, first detected in the U.K. in December, has already raised alarms about whether the COVID-19 virus is now escaping from the protection that vaccines just being rolled out now might provide. The variant has also been found in the U.S. So far more than 40 countries banned travelers from the region in an effort to keep the new strain from spreading to other parts of the world.

In a worst case scenario, those changes could push the virus to become resistant to the immune cells generated by currently available vaccines.

The fact that SARS-CoV-2 is morphing into potentially more dangerous strains isn’t a surprise. Viruses mutate. They must, in order to make up for a critical omission in their makeup. Unlike other pathogens such as bacteria, fungi and parasites, viruses have none of the machinery needed to make more copies of themselves, so they cannot reproduce on their own. They rely fully on hijacking the reproductive tools of the cells they infect in order to generate their progeny.

The so-called N501Y variant (some health officials are also calling it B.1.1.7.), which was recently detected in the U.K. and the U.S., may be a different story. Based on lab and animal studies, researchers believe this strain can spread more easily between people. That’s not a surprise, says Baric, since to this point, most of the world’s population has not been exposed to SARS-CoV-2. That means that for now, the strains that are better at hopping from one person to another will have the advantage in spreading their genetic code.

Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, and chief medical advisor to President-elect Joe Biden, says that his teams are sequencing and studying the new variants to better understand what effect they might have on disease, how close they might be to causing more severe illness and, more importantly as more people get vaccinated, whether the new variants can escape the protection of the vaccines we know work today.

The good news is that if the mutant strains do become resistant to the current vaccines, the mRNA technology behind the Pfizer-BioNTech and Moderna should enable the companies to develop new shots without the same lengthy developing and testing that the originals required.

Tracking every change the virus makes will be critical to buying the time needed to shift vaccine targets before SARS-CoV-2 leaps too far ahead for scientists to catch up. “We are taking [these variants] seriously and will be following them closely to make sure we don’t miss anything,” says Fauci.

There are thousands of lab tests, and their results can mean different things. But a few general guidelines can help shed some light.

If you’re waiting for lab test results to come back or you’re trying to figure out what they mean, the process and all those medical terms and numbers can be confusing.

There are thousands of lab tests, and their results can mean different things. But a few general guidelines can help shed some light.

What do my results mean?

Here are a few things to look for:

Positive vs. Negative. Some lab tests answer yes-or-no questions like whether you’re pregnant or have certain kinds of infections. These results are usually written as “positive” or “negative.” In this case, positive doesn’t necessarily mean “good” and negative doesn’t necessarily mean “bad.” Instead:

  • Positive: The lab found whatever your doctor was testing for. So if you had a test for strep throat, testing positive means you do have strep throat.

  • Negative: The lab didn’t find whatever you were tested for. A negative result for strep throat means that the lab didn’t find any strep bacteria in the sample, so you probably don’t have it.

Sometimes, the result might be “inconclusive.” That means the lab doesn’t have a clear yes or no answer based on your sample. Your doctor may want you to do the test again or have another kind of test.

Reference Ranges. A lot of lab test results don’t give clear answers. Instead, they’re shown as a number -- like your cholesterol levels.

These numbers don’t mean anything on their own, so you have to see how yours compare to a healthy range called your “reference range” or “reference value.” You’ll see this range on the lab test results.

Are lab test results always right?

While they do have to meet very high standards, they can be wrong sometimes. For example, you might get a false positive (the results say you have the condition you were tested for, but you really don’t) or a false negative (the results say you don’t have a condition, but you really do).

Lots of things can affect certain lab test results, like:

When you get your results, ask your doctor how accurate the test is. If your doctor thinks your results may not be right, she may recommend that you do the test again or take a different test.

What if my lab results aren’t “normal”?

It’s easy to be concerned if you see words like “abnormal” on your results. But that’s not all that unusual. For example, if your results are just outside the reference range, it may not necessarily be a problem.

If you’re worried about any of your results or have any questions, call your doctor’s office. You can talk to a nurse or schedule an appointment with your doctor to talk about them. She can help you understand what your results mean for you.

Lab Test Tips

Always keep a copy of your results. This can be useful in case you switch doctors, need to show them to a specialist, or just want to look at them again later. Remind your doctor if you take medications or have a health condition that can affect your results. That should be in your record, but it’s still a good idea to mention it.

Be honest if you didn’t follow the instructions. With some lab tests, you’re supposed to fast (not eat), or not do certain activities, eat certain foods, or take certain drugs. If you forget and mess up, don’t worry -- just tell your doctor before you do the test. It’s not a big deal to reschedule, and it’s a waste of time to get the test if the results won’t be right.

Make sure your doctor always uses the same lab to do your tests if possible. It can be hard to compare results from different labs because they may approach the test differently. For example, one lab might have different ranges for “normal” and “abnormal” than another.

Ask your doctor questions about your results like:

  • Why did I need this test?

  • What exactly does this test result mean?

  • How accurate is this test?

  • When will I need to do this test again?

  • Based on my results, do I need treatment or other tests?