NEW DELHI: In a move to increase the current testing capacity for COVID-19 in India, orders have been placed for close to 6.3 million (63 lakh) RT-PCR testing kits.
A senior Health Ministry official, while speaking to ANI, said that the target is to test 5.3 million (53 lakh) Indians in the coming months. Therefore, an order slightly in excess of the figure was placed to provide for backups in the event test kits malfunctioned.
Companies in South Korea, Germany, the USA and China will be supplying these RT-PCR kits to India. The health officials estimated that the first batch of kits should arrive in India after May 10 and the rest will be supplied in a phased manner.
Orders have been placed by India with 'Seegene' and 'SD Biosensor' in South Korea, 'Altona Diagnostic' in Germany, 'Life Technologies' in the USA and 'Shanghai Forum' in China. Out of these companies, South Korea's SD Biosensor has received a repeat order after successfully fulfilling India's initial requirement of RT-PCR test kits.
As per the Indian Council of Medical Research (ICMR), the standard protocol for diagnosis of COVID-19 infection is an RT-PCR test of the throat and/or nasal swab, which detects virus at an early stage. This is also considered the most reliable method for diagnosis with a high accuracy rate.
There are three steps involved in testing a coronavirus sample. (i) Sample collection -- a VTM (Viral Transport Medium) kit is required to collect the sample and to store the throat swab and nasal swab in VTM tube (ii) RNA kit is used for RNA extraction or purification of COVID sample (iii) RT-PCR kit -- is finally used to detect the virus in the sample.
A senior official Health Ministry told ANI: "At present, we have at least 10,63,500 complete testing kits available including VTM, RNA extraction kits and RT-PCR kits."
"To ramp up our testing speed, we have given immediate orders for about 63 Lakh RT-PCR kits as per our requirement. We are hoping to receive it within this month," the senior Health Ministry official told ANI.
All real-time RT-PCR kits are approved by USFDA and European CE. In addition, real-time RT-PCR kits have also been validated by ICMR-NIV, Pune. Dr Balram Bhargava, Director General of ICMR had stressed that to contain coronavirus infection, RT-PCR tests must be continued vigorously as the principal diagnostic test.
The Central government has taken on the responsibility of assisting State governments with testing kits. However, they are also free to procure on their own to expedite and scale-up testing in their respective States. Some states have initiated such steps.
The Department of Health Research (DHR) has assessed the requirement of manual RT-PCR kits as 35 lakhs for which probe, primer and master mix have been ordered. Probes, primers and a master mix are reagents needed to conduct successful RT-PCR tests.
Recently, separate from the current order of 6.3 million test kets to be sourced from abroad, material for about 16.4 lakh tests have been received. A further order of two lakh kits was placed with domestic manufacturers as well, which are still awaited.
Further, the DHR has ordered 2 lakh Roche's COBAS test kits, of which 60,000 kits have been received. These are high-speed testing kits.
On Saturday, ANI reported that the apex medical research body had crossed over one million RT-PCR tests for COVID19. Till date, the ICMR has done 10,46,450 tests.