Validation of test technologies for the novel coronavirus at the National Institute of Virology (NIV), Pune ,may take some months. While multiple technologies are being validated, the institute is not sharing positive control samples of the isolated virus with private players.

Positive controls are primarily derived from samples of Covid-19 patients and are non-infectious portions of the virus genome made synthetically. “Positive controls can also be imported, but currently there is a worldwide shortage . Hence, we have to depend on NIV and are working along with them,” a private player said. GSK Velu, Chairman of Trivitron Healthcare, which is validating domestic test kits with NIV, said the government body is not sharing them as they want to control testing.

An executive of Goa-based Molbio Diagnostics said that while private players were preparing to test for Covid-19, the government is yet to provide them an estimate on the number. At present, the government only tests symptomatic patients who have international travel history or are in contact with them. Till date, there are 219 Covid-19 confirmed cases, but the actual number could be higher as cases could be going undetected in the community.

In the testing criteria expansion on Friday, the Health Ministry has said that all pneumonia patients should now be notified so they can be tested for COVID19 in government set-ups.

While the ICMR is looking to scale up the Polymerase Chain Reaction (PCR) lab number to 72, industry sources said that there may be no more than 200 PCR machines in the government setting. Despite many private labs being on stand by, the Ministry of Health and Family Welfare is yet to issue any guidelines on allowing them to test.

Also, to expedite testing of suspect throat swabs for Covid-19, the government is in the process of validating Molbio’s Truenat machine, used for multi-drug resistant tuberculosis (TB) diagnosis. Priya Abraham, Director of NIV, has confirmed this.

Bench-top machine

Truenat is a bench-top machine that uses real time PCR technology, similar to the machines deployed in government labs, including the two high-volume units installed by Roche Diagnostics at the Regional Medical Research Centre, Bhubaneswar, and the National Institute of Biologicals, Ghaziabad.

The difference, the executive said, is that Truenat is smaller, battery operated, requires minimal training and is usable even in smaller settings such as the Primary Health Centre.

Truenat uses a chip-based technology and takes just up to 60 minutes for a test, screening or confirmatory.

“Truenat has got test licences for Covid-19 assay from the Drug Controller General of India, but will receive final licence once the NIV gives the final nod,” the executive stated.

The cost of a test on Truenat will be ₹1,000-₹1,500, the executive said. This is a fifth of what it costs today.

“We cannot run tests completely for free, but a few of us have written to the ICMR saying we can explore that option if the government provides us with the test kits,” Velu said.

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