Following incidents of complaints from several states including West Bengal and Rajasthan citing 'objectionable' accuracy by the rapid testing kits provided by the Indian Council of Medical Research, two Chinese manufacturers have come under the primary medical body's scanner. These two manufacturers are - Guangzhou Wondfo Biotech CO. Ltd and Zhuhai Livzon Diagnostics. According to an ICMR official, Guanzhou Wondfo Biotech provided about 5 lakh rapid antibody test kits while Zhuhai Livzon provided 2 lakh kits to four suppliers across the country.
The variations in the results and inaccuracy by the testing kits led to ICMR instructing states to pause the usage of the kits for 2 days until it conducts an investigation. The supplies were brought to India through multiple sorties conducted by Air India and other commercial Indian jetliners amid the Coronavirus lockdown. So far, there are 15,474 active cases in the country while 3,869 patients have recovered from the disease. The country has also witnessed 640 deaths due to COVID-19.
The ICMR on Tuesday directed the state governments to not use the rapid testing kits for the next two days. The development came after various states complained about the accuracy of the aforesaid kits. Addressing a press briefing on Tuesday, Dr.Raman Gangakhedkar- the head of Epidemiology and Communicable Diseases at ICMR conceded that there was a significant variation in the positive RT-PCR samples.
At the same time, he observed that tests might be in a crude form as only three and a half months had passed since the outbreak of the novel coronavirus pandemic. Additionally, Dr.Gangakhedkar announced that the ICMR would try to validate the kits in the field instead of laboratories in the coming two days and issue a detailed advisory subsequently.
The rapid antibody test kits entail the testing of blood samples and are aimed at speeding up the screening and detection of suspect COVID-19 patients. This is because it takes more time for the results of swab-based tests in labs. It is pertinent to note that the RT-PCR is the only confirmatory test for COVID-19. Approved by the US FDA, the rapid test kits are meant only for surveillance and trend checking.