In India Diagnosing COVID-19 with one more testing method started from Monday. This rapid antigen detection test method is approved by ICMR. Under specific settings, you can use this rapid antigen detection kits.
So, what is this new test all about?
It is one of the point of care tests, which is usually conducted on the spot, to check and deliver results rapidly. Yes, the person to be tested is made to sit on a table and his nasal samples are collected by the lab technician who is completely wearing safety gear. These nasal samples are tested for the presence of any foreign bodies that can potentially stimulate an immune response. These are usually found in the SARS viruses. COVID-19 belongs to SARS family.
INDIAN council for medical research has granted permission for these test kits, which are manufactured by the South Korean based company S D Biosensor, which has its operational outlet in Manesar. Yes, this is quite handy for the lab technicians as it comes with a sterile swab too. It is easy for collection in that way. There is a viral extraction tube also in this Standard Q COVID-19 Ag detection kit. It has a few essentials of the other kind, like the testing device to detect the antigen, and the viral cell disintegration buffer.
RT-PCR test is different from the above new testing kit
The gold standards are awarded to the RT-PCR test already for its versatility and functional value. That is why it is one of the frontline tests that are recommended so far by the ICMR and other governing bodies. Just similar to the RT-PCR test, even in the case of rapid antigen testing, it is easy to identify the virus rather than focusing on the antibodies. Principle of operation is very different for the two kinds of tests, though. However, the time taken by the rapid antigen test to identify the virus is significantly lesser. It is possible to interpret the outcome of the test results as positive or negative just within half an hour. In that way, you are curbing the difficulties to transport the sample to the laboratory, for mass detection, as it is in the case of RT-PCR test. It is time-consuming and the chances of mixing up, are on the higher side, during the transportation of the samples to the lab.
Why SD Biosensor?
Permission has been granted for only brand, from SD Biosensor to make the rapid antigen test kit. There are special reasons for that. Globally only a few of the test kits are accepted and approved to be used for the mass testing process. Earlier, the Quidel’s antigen test kit was approved by the US governing body, FDA. This was the first-ever antigen test that was approved by the food and drug administration – FDA in the USA. This was on 9th of May, this year. In just a week, Japan’s health care governing bodies, also approved another testing kit, which was from the Tokyo based company Fujirebio Inc. This is profoundly known as the Fujirebio Inc’s antigen testing kit.
Following the USA, and Japan, India too conducted the two evaluation tests independently in different places. It was conducted at the ICMR and at the AIIMS. That is when the SD Biosensor product was approved for its phenomenal value. The kit is named as the rapid antigen test kit.
The specialty of the rapid antigen test kit is that it has the capacity to precisely identify the negatives ranging between the 99.3 percent to 100 percent. This was identified to work well at both the sites where the evaluation tests were conducted at a time. Similarly, the testing kit was found to detect the genuine positivity who are ranging from anywhere in between the 50 percent to the 84 percent. Depending upon the victim’s viral load, the test gives you the results precisely.
Now, the interesting attribute to note here about the rapid antigen test is the reliability of the positive reports. It has a better ability to detect genuine negatives quicker. So, the positive reports are highly reliable. So, permission has been granted to the company to market the kit all over the country. At the same time, the Indian council of medical research has also invited other manufacturers to come forward and submit their own antigen detection kits, for evaluation and testing.
Rapid antigen test- where to deploy it?
Hotspots are the target. Containment zones are where you can use the kit to find out the positive cases. It is permitted to use the kit in the health care facilities too. The testing has to be conducted under strict medical supervision. The kit has to be maintained in the optimal temperature range of 2.0 to 30.0 degree Celsius.
It is possible to conduct the tests in the hotspots for identifying the illnesses related to the symptomatic influenza. In case of testing the asymptomatic cases, which come into contact directly with the high-risk patients, with co-morbidities can be tested from the 5th till 10th day of directly coming into contact. This co-morbidities would include the patients, with lung diseases, diabetes, kidney diseases, liver ailments, blood circulation disorders, neurological ailments, and heart diseases.
It is possible to test all the cases in the health care set up, with some symptoms of influenza. Suspects of having an infection of COVID-19 can be tested in the health care set up.
All the patients who are asymptomatic but getting hospitalized for treatment of ailments like chemotherapy, anyone over the age of sixty-five having co-morbidities, post-transplant patients, immune suppressant victims who are suffering already from HIV, can be tested.
The rapid antigen test can be used to check patients who are asymptomatic but still undergoing dialysis, or surgical procedures and surgical interventions, in the field of ENT, dental, and neurosurgery.
Is there a need to double check for confirmation of COVID-19?
There is no need for testing again, if you are testing positive once. Those who are testing negative must be checked again for infection, by undergoing the RT-PCR test.
Limitations
Molecular PCR tests are the sensitive ones for the virus as per the US guidelines. Even though, the antigen tests are very specific to detect the COVID, negative cases cannot be completely ruled out. Positive results are precise. Just because of the fact that one is showing negative, one cannot be completely ruled out from the possibility of a potential infection. So, to avoid the spread of the infection, because of the false negatives, it is advisable to test the patient again with the RT-PCR kit. This is the guidelines from the Food and Drugs Administration, USA.
The sample can be active for testing for only an hour. It is necessary to get the test done on the spot, at the earliest. The ICMR has hence advised to do the tests on the spot for collecting samples in a healthcare set up. The company that has made rapid antigen testing kit has come up with guidelines too.
If the sample specimen taken from a particular spot, is not having an adequate concentration of the antigen, then the poor quality specimen can also lead to show wrong results. Children are generally found to be shedding the virus for long time more than the adults are. So, it is easy to detect the cases in that category with mild specimens too.
Disclaimer: This content including advice provides generic information only. It is in no way a substitute for qualified medical opinion. Always consult a specialist or your own doctor for more information. Anti Vibration Technologies does not claim responsibility for this information.