ICMR issues revised guidance document on rapid antibody test kits for Covid-19

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Published: May 14, 2020 9:23:21 PM

Covid testing: The revised document also mentions the two Chinese firms, but states that "the marketing licenses to the distributors of these two companies have been cancelled by the Central Drugs Standard Control Organization (CDSCO)".

The health research body, however, underlined that such rapid antibody test are not recommended for diagnosis of coronavirus infection.

The ICMR on Thursday issued revised guidance document on rapid antibody test kits for COVID-19 and listed the firms whose kits have been validated and found satisfactory. The apex health research body had issued on Wednesday night a guidance document in which two Chinese firms — Guangzhou Wondfo Biotech and Zhuhai Livzon Diagnostics — whose importer’s licenses were cancelled by the Central Drugs Standard Control Organisation last month, found a mention among the list of companies, test kits of whose, have been validated at the National Institute of Virology (NIV), Pune so far.

The document, however, was taken down from the website in the morning and a revised one was uploaded later.
The revised document also mentions the two Chinese firms, but states that “the marketing licenses to the distributors of these two companies have been cancelled by the Central Drugs Standard Control Organization (CDSCO).”

The health research body, however, underlined that such rapid antibody test are not recommended for diagnosis of coronavirus infection. It had earlier said that such test kits are to be used only for surveillance purpose. “Till date, 42 antibody-based rapid tests have been validated, and the following were found to be satisfactory. Ten of these kits are manufactured in India,” the ICMR said in the revised guidance document.

“These rapid antibody test kits have been validated in the laboratory. However, the performance of the kits may be subject to variation under field conditions,” the ICMR underlined. According to the guidance document, the rapid tests can be done on blood/serum/plasma samples and the result is available within 30 minutes. “The test may remain positive for several weeks after infection. A positive test indicates exposure to SARS-CoV-2 while a negative test does not rule out COVID-19 infection,” the ICMR said.

The list of kits includes COVID-19 IgM IgG Rapid Test: BioMedomics (CE-IVD); New Coronavirus (COVID-19) IgG/IgM Rapid Test: Voxtur Bio Ltd, India; Makesure COVID-19 Rapid test: HLL Lifecare Limited, Indi; Abchek COVID-19 IgM/IgG Antibody Rapid Test: NuLifecare and; One Step COVID-19 IgM/IgG Antibody: SIDAK Life Care Pvt. Ltd. The list also mentions the batch numbers of the kits.

The Centre on April 27 had said that it has “not lost a single rupee” with respect to the supplies of the COVID-19 rapid antibody test kits while cancelling the shipment of the equipment from two Chinese companies after those were found to be “under-performing”.

In an advisory sent to chief secretaries of all states and Union Territories, the ICMR had said that it “evaluated the kits of Guangzhou Wondfo Biotech and Zhuhai Livson Diagnostics in field conditions. The results have shown wide variation in their sensitivity, despite an early promise of good performance for surveillance purpose”. The testing technique is used to detect antibodies in the blood of people who may have had novel coronavirus infection.

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