We hope, here, to explain tests for Covid-19 (the disease) or SARS-CoV2 (the virus causing the disease) clearly, the use and value of such tests, and the superiority of Newgene-US tests vs alternatives, so that you can gain an understanding of such tests and make intelligent test-buying decisions in regard to your own pursuit of combatting the current pandemic &/or post-pandemic policies aimed at preventing a resugence of the disease:
First, to understand the value of tests & testing, in general, it is helpful to understand what the SARS2 coronavirus is and how different test work.
Frankly, in regard to the virus, it doesn’t consist of much…even though it has the capability of killing! Viruses, in general, consist of nothing more than some genetic material (a strand or stands of DNA or RNA) in an outer envelope. In the case of the cornavirus, the genetic material is RNA. The outer envelope of the virus is composed of different proteins and lipids (related to fats) and has spikes of proteins that serve to act as a “key” that latches onto specific “keyhole” receptors on target body cells.
Both the genetic material & the outer (shell or spike) proteins consist of chains of amino acids that are selectively detected by various tests.
Obviously, a virus is a very simple organism. In fact, there is so much missing in viruses, that usually comprises the structures of living cells, there is disagreement about whether one can even consider them to be “alive” in the conventional sense. In fact, viruses do not display the usual activities that define a living cell:
- Respiration (That is, taking in oxygen and giving off carbon dioxide)
- Nutrition & excretion (that is, taking in nourishment and giving off waste products)
- Reproduction (using the cells own mechanisms for division) without the need to usurp the mechanisms of other cells
All viruses do is reproduce, but they do not contain the mechanisms for doing so on their own. They must hijack the mechanisms of other truly living cells in order to reproduce. And, in doing so, they damage or destroy those other cells.
It is either the death of, or damage to, those host cells,,,or the body’s reaction or over-reaction to the presence of the virus,,,that what causes the disease. And, part of the body’s reaction, in addition to trying to prevent damage by the live virus, is to build defenses (immunity) against future infection by the same virus. Initiating that same immunity (w/o causing the disease) is the intent of vaccines.
With that introduction, it should be obvious what testing for the novel coronavirus looks for:
- The slow & expensive, but accurate PCR tests identify the actual, central,viral RNA;
- Fast/Antigen tests identify the presence of specific viral proteins in the viral shell or “spikes”…being the antigens that the body reacts to (& which also can mutate into so-called “variants” as the pandemic persists);
- The presence of antibodies…the body’s reaction to the presence of the viral antigens, as a protection against reinfection.
That having been said, it must also be said that the various tests are far from equivalent to each other, differing from each other in terms of:
Accuracy (“specificity”)…the ability of a test to display a positive result for the coronavirus, but not a “false positive” for other viruses;
Sensitivity…the ability to detect low viral loads in the body (ie: early in the infection);
- Specificity (accuracy)…ability to give accurate results for the coronavirus, with a minimum of false positives;
- Sensitivity…ability to detect minimal levels of infection, with a minimum of false negatives;
- Cost, equipment &/or special personnel required…ability for an untrained person to do the test without specialized training or additional equipment.
- Speed of the test, including whether results are available “on the spot”, as opposed to results being delayed because of requirement for sample to be submitted for lab analysis.
In that regard, the following chart shows that the Newgene-US tests have benefits that exceed those of all competitive fast tests, and very nearly achieve the accuracy and sensitivity of the “gold standard” RT-PCR test:
PCR Test: This is often considered “the gold standard”, which actually looks for a specific part of the virus’ genetic code in its RNA, a segment of RNA that is not likely to be mistaken for that from a different pathogen. This test procedure includes a process that literally multiplies the amount of that genetic material in the sample, which helps ensure that there is enough of it to be detected. Thus, it is the most sensitive and specific of the tests.
But, even this test is not perfect. It is a complicated procedure that requires expensive equipment and trained technicians to obtain the sample and run the test. Because of this, the test takes significant time before results are available and that is a significant hurdle to effective & prompt testing and tracing. While an individual test can be completed in 3 hours or less, with thousands of tests being run, the results of an individual test tend not to be available for 3 to 8 days after the sample is obtained. This delay is counter-productive when the persons being tested need to know whether they should be quarantining or not. It is not much use is an ultimately positive test result is not available until after the tested person has been spreading the virus for days, while awaiting the test results!
In addition, while “false positives” are rare, “false negatives” do occur, in which an infection is not detected. The error can occur because of bad sampling, as well as from errors in the analytical procedure. And, if fact, the virus is not uniformly distributed in the nasal passages. Thus, even a skilled technician may not “grab” an adequate sample of the virus in a sample, because the technician is obviously “working in the dark” in trying to sample deep in the nose or throat. This is the likely reason why multiple PCR tests can show contrasting results.
However, the bigger problem of the PCR test is that is cannot be adapted to be a self/home test. The need for specialized equipment & technicians makes it costly. The price is seldom less than $100, and charges of over $1,000 are not unheard of. Hence, unless the cost is covered by insurance, a large segment of the population cannot afford the test. Also, when there is a lengthy time between sampling and receipt of test results, the value of the test in fighting contagion is diminished.
By its very nature, the PCR test is inherently time-consuming, expensive, and requires trained technicians. But, it is generally accurate and the most sensitive of all tests, capable of detecting coronavirus infections 1-3 days earlier than “fast tests”, because part of its process is to actually multiply the viral load that is present. For this reason, the PCR test remains a valuable tool in the covid defense “tool-kit”. And, for that reason, Newgene-US makes affordable swabs, vials, full sampling kits and the highest quality reagents used for these tests.
Another value of the PCR test is that its standard practice is to test for multiple segments of the genetic material, whereas antigen tests generally seek out a single specific protein. For this reason, a value of the PCR test, vs antigens tests, is that the virus is unlikely to mutate so much that the PCR test can’t detect it, whereas an antigen test that looks for a single proten, can becomes ineffective if that protein mutates. The quest to overcome that weakness of antigen tests is something that distinguishes the most dedicate researcher-manufacturers, like Newgene.
Antibody Test: Seeking out the antibodies that the body produces as a reaction to the virus. But, because it takes at least 5-6 days of infection for detectable antibodies to be produced, it does not detect early infections, when a person may already be contagious. And, it does not differentiate between a current infection of some minimal duration and a prior infection…because the antibodies persist for at least 2-3 months after the live virus is gone from the body. Hence, the antibody test, by itself, does not inform the person being tested whether they are currently contagious.
The bigger problem with the first such tests is that they were nowhere near as specific nor as sensitive as the PCR test. In fact, because these test were fast and inexpensive, millions of them were sold, though many of them had had accuracy as random as a “flip of a coin”…literally 50/50. Newer versions of the test are much more accurate and consistent. These have value, but do not differentiate between an active infection or a recent past infection. However, these tests are valuable as a “double-check” of other tests: By comparing the antibody test with a PCR or antigen test, a good indication can be made as to whether there is a current or past covid infection, and whether it is early in the infection, because the antigens are detectable before the antibodies. The flood of inaccurate antibody tests has been to a great extent “weeded out” at this point, with approval for many of these tests being pulled by the US FDA. But, the Newgene-US antibody test for covid-19 remains approved by the US FDA, meeting its newest minimum standards for sensitivity and accuracy.
In addition, as with a good fast antigen test, the fast antibody tests are so simple that anyone can obtain the single drop of blood needed, and run the test themselves, not much different than the “sugar” tests millions of diabetics run on themselves as often as several times every day. The Newgene antibody test is accurate and specific enough to have received an FDA EUA, and is sold with everything necessary to get a result in 10-15 minutes. Hence, the antibody test has value, though we caution that its value is greatly enhanced when paired with the antigen test.
Antigen Test: This test detects specific proteins in the outer shell or “spikes” of viruses, and can be designed to be very specific for particular viruses. In fact, they are so specific that different tests will have to be created if the variants “popping up” become prevalent. Newgene-US is at the forefront of developing antigen test that detects elements common to all variants, which will prevent the test from having to be modified every time a new variant becomes prevalent. Also, properly designed, the tests closely approach the specificity and sensitivity of the PCR test. In fact, the differences can be close to the margin of error of the PCR test itself.
Though it can sometimes invade the blood, SARS-CoV2 is specifically a respiratory virus. And, even in the respiratory tract, the presence of the virus, during an infection, is not uniform, and is less in the mouth and throat or nose.. Hence, as with the PCR test, the best samples are from the respiratory system, but even deep nasal samples obtained by a technician can be “hit or miss”.. By contrast,, the genius of the Newgene-US tests is that they are designed such that a sputum sample (mucous that can be obtained with a deep cough, or throat clearing), is analyzed. Because the production of sputum is a direct result of the virus, it must contain the virus, and the virus will only fail to be detected by the Newgene-US antigen test at the very earliest stage of infection, before the viral load reaches a level that the test is capable of detecting. Because of this test protocol, the results are very nearly as accurate as PCR analysis of naso-pharyngeal sample obtained by a technician. In fact, it is suspected that that there are cases in which a presumed false positive of the Newgene-US test is actually a case of a false negative of the PCR test! Though the Newgene antigen test is awaiting FDA certification, it is fully certified in the Euro-Union, India, various S. American countries, individual Euro countries and the UK.
Production Capacity: While many test makers are “bragging” that they expect to reach larger production capacity, such as a million tests per week by the end of 2021…Newgene already has production capacity in excess of 1 millions tests per day right now. And, with a lead time of as little as ten days, production can be ramped up to as much as 3 millions tests per day. This is currently unheard-of in the industry.
Cost: Newgene is proud to be able to offer fast antigen tests at bulk or retail costs that are significantly below the cost of competing fast tests. In fact, the individual cost approaches that of the cheap ineffective antibody tests that were previously dumped on the market in the millions. Because the Newgene tests do not require a supplemental app or reader device, there is less waste produced from each test, and the cost can be held down. Those certified fast tests that do utilize a reader device are multiples of the cost of Newgene tests. And even the most recent fast self-antigen test that does not require a reader is retail priced, for this single test, as much are the Newgene triple test (which includes priority postage to a US user).
Packaging Configuration: While Newgene tests innovative design work as self/home tests and are available in individual packaging, the tests are suitable for use in a lab or clinical setting, and are available packaged in boxes of 20 or 25 tests, with long sterile rather than short “Q-tip” type swab.
Dual Tests: In order to best help the public access accurate testing, Newgene offers dual tests that, in one cassette, test for both antibodies and antigens of Covid-19; and antigen tests for both covid & influenza A/B. By combining the latter test with a covid antibody test, our “Lab in a Bag” is a triple tests almost a good as a doctor visit! The only similar test on the market is a much more costly and tedious PCR test, available only by prescription.
Testing for Influenza: A critical problem is that both influenza and covid-19 are both respiratory diseases and simultaneous infection is possible…with a more severe level of illness than when the patient is infected for either disease by itself. Thus, even a mild case of covid-19 in a vaccinated patient, will be worsened if they are simultaneously stricken with the flu.. Hence, Newgene-US offers a dual test that can reveal cases of multiple infection simultaneously.
OEM Tests: OEM packaging is offered for the Covid Antigen, Anibody and Dual Antigen/Antibody tests provided that the packaging meets government requirement in the country where the tests are to be sold. While these tests can be used by labs or for home/self testing, the OEM buyer is responsible for obtaining any approvals required for home/self testing.
