India pauses antibody testing; US FDA says it hasn’t approved any antibody kits

As countries consider widespread testing and experts debate the merits and ethics of “immunity certificates”, more and more red flags are being raised on the quality and reliability of antibody testing kits even as governments issue warnings about what rapid antibody tests can and cannot do.  

Until a vaccine or a cure for COVID-19 is devised, widespread testing to identify those who have been infected and recovered, and hence developed immunity to the SARS-CoV-2 virus (at least in theory), could allow them to resume normal work and social life. 

However, the evidence is far from conclusive on whether recovering from COVID-19 confers immunity, and for how long. 

More immediately, countries are flagging problems with the thousands of rapid antibody testing kits that they ordered on war footing. Yesterday, April 21, 2020, the Indian government said it was investigating complaints that some antibody kits bought from China had been inaccurate, asking states to hold off on using the tests for two days until government agencies could validate the tests.

The same day, the US Food and Drug Administration (FDA) issued a safety alert for antibody tests and said, “The FDA is not aware of an antibody test that has been validated for diagnosis of SARS-CoV-2 infection.” This means, antibody tests cannot be used to diagnose whether someone has acquired a COVID-19 infection. 

It went further to say that while the FDA is open to receiving applications for approval of rapid testing kits for diagnosis, “based on the underlying scientific principles of antibody tests, the FDA does not expect that an antibody test can be shown to definitively diagnose or exclude SARS-CoV-2 infection”.

Over recent press conferences and government circulars, the Indian government has also reiterated that rapid antibody tests should be used only for surveillance and not for diagnosis. Earlier, on April 8, 2020, the World Health Organization (WHO) specified that: “WHO recommends the use of these new point-of-care immunodiagnostic tests only in research settings. They should not be used in any other setting, including for clinical decision-making, until evidence supporting use for specific indications is available.”

Regarding kits being faulty, India has not specified which antibody kits are being investigated, whether Chinese or other. However, the bulk of the 84 kits approved so far by the Indian government are from Chinese companies.

The Chinese Embassy in India tweeted on April 22, 2020, that they have taken cognisance of reports concerning the quality of rapid testing kits exported by China and that “China attaches great importance to the quality of exported medical products. Will keep close communication with Indian concerned agency and provide necessary assistance.”

Chinese testing kits have come under criticism around the world, particularly in Spain (where the government put the accuracy rate of Chinese kits at 30%), Turkey, and the Netherlands.

As countries consider widespread testing and experts debate the merits and ethics of “immunity certificates”, more and more red flags are being raised on the quality and reliability of antibody testing kits even as governments issue warnings about what rapid antibody tests can and cannot do.  

Until a vaccine or a cure for COVID-19 is devised, widespread testing to identify those who have been infected and recovered, and hence developed immunity to the SARS-CoV-2 virus (at least in theory), could allow them to resume normal work and social life. 

However, the evidence is far from conclusive on whether recovering from COVID-19 confers immunity, and for how long. 

More immediately, countries are flagging problems with the thousands of rapid antibody testing kits that they ordered on war footing. Yesterday, April 21, 2020, the Indian government said it was investigating complaints that some antibody kits bought from China had been inaccurate, asking states to hold off on using the tests for two days until government agencies could validate the tests.

The same day, the US Food and Drug Administration (FDA) issued a safety alert for antibody tests and said, “The FDA is not aware of an antibody test that has been validated for diagnosis of SARS-CoV-2 infection.” This means, antibody tests cannot be used to diagnose whether someone has acquired a COVID-19 infection. 

It went further to say that while the FDA is open to receiving applications for approval of rapid testing kits for diagnosis, “based on the underlying scientific principles of antibody tests, the FDA does not expect that an antibody test can be shown to definitively diagnose or exclude SARS-CoV-2 infection”.

Over recent press conferences and government circulars, the Indian government has also reiterated that rapid antibody tests should be used only for surveillance and not for diagnosis. Earlier, on April 8, 2020, the World Health Organization (WHO) specified that: “WHO recommends the use of these new point-of-care immunodiagnostic tests only in research settings. They should not be used in any other setting, including for clinical decision-making, until evidence supporting use for specific indications is available.”

Regarding kits being faulty, India has not specified which antibody kits are being investigated, whether Chinese or other. However, the bulk of the 84 kits approved so far by the Indian government are from Chinese companies.

The Chinese Embassy in India tweeted on April 22, 2020, that they have taken cognisance of reports concerning the quality of rapid testing kits exported by China and that “China attaches great importance to the quality of exported medical products. Will keep close communication with Indian concerned agency and provide necessary assistance.”

Chinese testing kits have come under criticism around the world, particularly in Spain (where the government put the accuracy rate of Chinese kits at 30%), Turkey, and the Netherlands.


One response to “India pauses antibody testing; US FDA says it hasn’t approved any antibody kits”

  1. Nice news article related to limitations on rapid testing.

    1. We shouldn’t take FDA approval as the gold standard for COVID-19 and in the context of India. It is worth noting that even FDA-approved testing kits may fail under given conditions. For example, the FDA granted emergency-use authorisation for the “fastest available molecular point-of-care test” by Abbott, which has issues as shown by some research labs in the US. CE-approved kits also need to be tested in India (European Council asks nations to test kits as well, since conditions may vary). It would be in our best interest if the ICMR updates its guidelines and calls for its own tests of international test kits.

    2. While in the press briefing Dr R. Gangakhedkar did mention rapid testing kits for antibodies are for surveillance and guidelines by the ICMR or union health ministry do mention this, it is worrying that certain hospitals or healthcare centres may not heed that and use antibody tests for screening of COVID-19.
    (a) See plan of doctors in PGIMS https://twitter.com/das_seed/status/1252304438343225344
    (b) https://www.indiatoday.in/coronavirus-outbreak/story/explainer-is-rapid-test-kit-problem-really-a-setback-for-india-s-fight-against-coronavirus-pandemic-1669697-2020-04-22
    (c) concern by an officer https://timesofindia.indiatimes.com/india/rajasthan-stops-rapid-tests-icmr-asks-other-states-to-pause/articleshow/75283005.cms

    3. There is misleading information about incubation period to see symptoms of COVID-19 and testing positive. Though the WHO says it is 10 days and some doctors in India (as in reference 2(a) above) assume it to be 10 days, the onset of symptoms may be in the third week (https://www.worldometers.info/coronavirus/coronavirus-incubation-period/). It is a big mistake to fail to test infected persons, while it is not that big a mistake to wrongly test non-infected persons. Using rapid testing of antibodies as a preliminary for RT-PCR test is a mistake that we need to avoid.

    4. Has the ICMR and union health ministry ensured that no hospitals will use rapid testing for screening? Or, if hospitals do use rapid testing for screening, then do they need to report it to the ICMR and make it public?

    5. Is the ICMR conducting a survey to estimate the incubation period in India? We have seen that there are lots of variants based on region, from percentage of asymptomatic to percentage of deaths. Would it not be important to have a survey on this to ensure how long an individual should remain under self-quarantine for everyone’s safety?

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