Indian companies are going on war-footing to developing kits that can test patients for coronavirus. One such company is Chennai-based Trivitron Healthcare, which is internally validating its home-grown COVID-19 PCR test kit.
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PCR or Polymerase Chain Reaction is the method where the sample of an infected people is collected by lab technicians from the throat or nose. Trivitron plans to submit the test kit with the National Institute of Virology (NIV) in Pune for approval next week. Following which the company will make the kit available in the market.
The USP of the test kit is its pricing. Trivitron has claimed that it will become 50 percent to 70 percent cheaper for labs to test samples when compared to other kits. Experts suggest that one of the key reasons for the reduction in cost is the material used to manufacture the kits. They are all indigenous, hence the overall cost of the product is reduced.
Another advantage is mass production of the kits. Trivitron has the ability to manufacture up to 500 to 1,000 test kits per day. The company said that once the approval is received from NIV-Pune, they will manufacture the kits as per the government’s requirement.
Additionally, Trivitron is developing a kit for point of care testing. With 85 percent accuracy, the point of care kit will test antibodies in minute quantities of blood.
Another company that has received a nod from regulators for its COVID-19 test kit is CoSara. The molecular diagnostic company is based in Gujarat with a manufacturing plant in the state. The company is a joint venture between Ambalal Sarabhai Enterprises (India) and Co-Diagnostics (US). The company's COVID-19 test kit reportedly delivers results within three hours.
Even as Indian companies are making headway on developing coronavirus test kits, Swiss-based Roche Diagnostic recently received USFDA's emergency authorisation approval.
The company has received the go ahead for the diagnostic test kit from the Central Drugs Standard Control Organisation earlier this week. The advantage of this kit is that it allows the testing of up to 1400 samples per day. Moreover, it is automated with no manual intervention. Roche will import select quantities of the kit for product performance evaluation.
While the progress made in the developments of the kits is commendable, experts have pointed out a potential bottleneck at NIV, Pune. Industry sources say the number of approvals for COVID-19 tests are piling up which could lead to a delay in approvals.