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The council said it was investigating the problem, as some states had reported large variations, ranging from 6% to 71%, in the results of rapid antibody kit tests, which it said were unacceptable and may require be replaced, which will be a setback for the government’s plan to use rapid tests for monitoring and tracking trends, although not for diagnosis.
On Tuesday morning, Rajasthan, the first state in the country to conduct rapid tests for Covid-19, decided to discontinue using the kit any longer, as the results were found to be inaccurate and not correlated with the results of the polymerase chain reaction. (PCR) test. This also triggered a nationwide reaction with many other states that suspended testing.
In a tweet on Tuesday night, Rajasthan Prime Minister Ashok Gehlot said: “He had previously suggested to the Government of India (GOI) that a centralized mechanism with adequate quality control guidelines for procurement of equipment could be developed. Unfortunately, this was not the case. Accepted. Had this suggestion been accepted, failure of the rapid test kits could have been avoided. We have written to ICMR for the same. ”
However, well-placed sources said the tests may not be to blame and may not have been used correctly. “The kits are not defective,” said an official familiar with the test strategy. “The use of these kits for diagnosis is guilty. The appropriate test for Covid is the RT-PCR test. States may have used a shortcut to view them as diagnostic tests,” he added.
Thanks to this, India’s testing rate dropped from 35,000 odd on Monday to 27,500 on Tuesday as states are using the testing infrastructure for antibody testing. ICMR is expected to issue detailed clarification soon. There have also been reports that the temperatures required for rapid tests have not been observed.
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The kits arrived last week after several delays and have been sourced from three China-based companies. In the first batch, some 3,000,000 kits arrived about two weeks after their expiration. In total, 6,50,000 with more in process will be delivered through domestic operations in collaboration with foreign companies and other orders that have been placed. Kits are shipped to states based on your requirements.
There were complaints from states with kits intended to be used in hot spots and red zones as a supplement to polymerase testing which are much more reliable but take longer as it is a four stage procedure to be carried out in the laboratories.
“On Monday, we received a state complaint about less detection through rapid antibody test kits. So we asked around three states on Tuesday and found that among positive RT-PCR samples, there is too much variation in testing antibody tests. ” said the ICMR chief of epidemiology and communicable diseases, Dr. RR Gangakhedkar. “In some places, 6% to 71% of the RT-PCR positive samples were positive,” he added.
ICMR has decided to send eight different teams to test and validate the kits in the field over the next two days, after which it will issue a new notice regarding the use of rapid antibody test kits. “If problems are found in the batches, we will tell the company and we can ask them to replace the batches,” said Dr. Gangakhedkar, while asking states to suspend testing via the rapid antibody kit until then. .
While concerns about the level of accuracy of rapid antibody tests were also previously raised, ICMR and the Ministry of Health argued that the tests would only be used for surveillance and trend monitoring. ICMR has recommended only RT-PCR tests to evaluate individuals who are suspected of Covid-19, which it said was the gold standard.
“This is not a good thing because when such a large variation is observed, we need to investigate further, even if it is the first generation of the test,” said Dr. Gangakhedkar. However, he said the rapid antibody test was a new, first-generation test and that it would take time to develop further and perform better in new diseases like Covid-19.
Highly located government sources told TOI that ICMR had clarified (at government meetings) that rapid test kits show positive reports only after seven days, the period it takes for a body to generate antibodies that can be detected. They also said that the purchases of these kits were made directly by ICMR.
“ICMR was directly involved in acquiring rapid test kits from China and South Korea. The suppliers were approved by the local government,” said a source.
In Rajasthan, a committee submitted its report after a study conducted on rapid tests. “SMS Medical College presented their report to us and found that those who tested positive for the PCR test were negative for Covid-19 on the rapid test. When we correlated the PCR results and the rapid tests, we found that only 5.4% agreed Ideally, the match should be at least 90%, “said Rajasthan Health Minister Raghu Sharma.
Maharashtra stopped using the quick test kits at the last minute. The state had received 75,000 kits and planned to carry out tests among health workers and, later, at critical points such as the Dharavi in Mumbai. The BMC had plans to start evaluating medical workers using the quick kits starting Wednesday. Dr. Anup Kumar Yadav, commissioner of the National Health Mission, said they have decided to wait 48 hours to receive the new ICMR notice.
West Bengal decided to put the rapid tests on hold until it obtained an authorization from the ICMR, Kolkata Mayor Firhad Hakim said Tuesday night. Bengal had examined 78 people on Monday and another 220 on Tuesday.
Punjab, which was one of the first states to point out the problem of low precision, decided not to use kits provided by the central government. To verify the accuracy of the kits, on April 19, Punjab’s chief health secretary Anurag Agarwal conducted a survey in Mohali and Jalandhar, the most affected districts in the state, using positive case tests. A random sampling was also carried out among the general public. In both categories, most of the samples collected showed false negative and positive results.
In Uttar Pradesh, Covid-19 state surveillance officer Vikasendu Agarwal said: “UP will put the use of quick kits on hold after ICMR observation.” UP had recently used the kits to evaluate more than 10,500 children who returned from Kota. The kits were also used for surveillance at Gautam Buddh Nagar hot spots.
Gujarat has also put its use on hold. “There are two confirmatory strips – IgM and IgG – in these kits. Both must be positive to confirm a case. But in certain cases, only one of the two strips shows results while the other strip fails, and therefore the case it’s not conclusive, “said chief secretary (health) Jayanthi Ravi.
Tamil Nadu, who ordered four lakh antibody rapid test kits, suspended their orders from Saturday. The managing director of the Tamil Nadu Medical Services Corporation, P Umanath, said his team was renegotiating the price and reevaluating the required stock after the ICMR said the tests cannot be used for diagnostic purposes.
While Assam and Haryana have also discontinued use of these kits, states like Madhya Pradesh, Kerala, Andhra Pradesh, and Telangana have yet to start using them.
