Coronavirus: India To Deploy Rapid Test Kits To Speed Up Covid-19 Screening
ICMR has released detailed guidelines for conducting serological antibody blood tests, which deliver results in 15 minutes.
India is looking to deploy rapid test kits to speed up Covid-19 screening, amid a spike in cases and growing coronavirus hotspots in the country.
The serological antibody blood test, which deliver results in 15 minutes, work on blood samples instead of nasal swabs and will tell whether a patient has ever been exposed to the novel virus. If put to use, this would be the first time India will use serology for detection of disease. Similar tests have been widely conducted to check for influenza, human immunodeficiency virus and Zika.
And scores of companies, domestic and international, have now queued up to provide rapid testing kits to India, the Indian Council for Medical Research said in a circular. The council had last month issued tenders for the procurement of 5 lakh antibody test kits. On Sunday, ICMR’s Chief Epidemiologist RR Gangakhedkar said that the kits may arrive by Wednesday.
“Population in hotspot areas may be tested using rapid antibody tests,” the ICMR had said in an interim advisory, adding that all the antibody positives would be confirmed by RT-PCR (polymerase chain reaction) using throat/nasal swab, and antibody negatives would be quarantined at home.
ICMR had also released detailed guidelines late yesterday for these tests. These are:
- Rapid antibody tests approved by U.S. FDA/CE-IVD or non-CE-IVD validated by ICMR-NIV with marketing approval by Drug Controller General can be used.
- All such organisations must register themselves on the ICMR portal and upload data in real time.
- Individuals who tested negative must be confirmed by real-time PCR test, if warranted or home quarantined, and repeat the antibody test after 10 days.
Until now, RT-PCR was the only way to identify Sars-CoV-2 virus. While highly accurate, the testing methodology has drawbacks, including taking up to five hours to deliver results.
That’s led to some countries lining up the rapid test kits. The U.K. has stocked up on more than 40 lakh finger-prick antibody blood tests, Bloomberg reported, saying that it’s also used in China, Singapore and other countries. The U.S., too, recently allowed rapid testing for detecting Covid-19.
The rapid test kits could speed up the screening process in a nation of 1.3 billion people where just about 70 percent of testing capacity has been utilised, according to the Union Ministry of Health. As on April 4, only 70,000 people were tested for Covid-19 at 132 state-run labs and 52 private labs. The number of tests conducted per day has been increased to 10,000, the ministry said.
What Companies Are Saying
Kit manufacturers that BloombergQuint spoke to said they have the capacity to meet the demand in the country.
Khushroo Pastakia, managing director of Voxtur Bio Ltd., one of the firms to have secured approval from National Institute of Virology in Pune, said they can make 1 crore test kits a month. The firm, which is in the process of getting approval from the Drug Controller General of India, has set up its manufacturing base Maharashtra. “We’re hoping to start providing kits from next week if all approvals come in.”
“Mass screening is critical at this stage,” Pastakia said. “These rapid tests will provide a very fast backup plan for the government to take action where real tests are required.”
Bengaluru-based Bione, which said its kit has been validated by the ICMR, said they can run tests in about 10 minutes. Dr Surendra K Chikara, the company’s chief executive officer, said they can make up to 20-30,000 kits a week, which are priced between Rs 2,000 and Rs 3,000 apiece. The company, Chikara said, would soon get approval from U.S. FDA, adding that they could even supply kits for at-home screening if permitted.
Tarshant Jain, head of Ozo Life, a company that’s said to have been approved by CE-IVD and was listed by ICMR in a circular dated March 28, however, said they may not be able to provide the kits in time.
“At a time of urgency when the players are ready to provide the kits, the government isn’t expediting the process of getting the qualification and approval from DCGI to start supplying to India,” he said over the phone. Jain said their firm, which has already sold 6 crore kits around the world, can produce around 2 crore rapid testing kits at Rs 1,500 apiece.
With many companies looking to provide rapid test kits to India, concerns over their quality have been raised.
That comes as European countries, including Spain, the Czech Republic and Turkey returned faulty batches and consignments from Chinese kit makers, some of whom even had EU certification.
Shanghai Fosun Pharmaceutical Group, a Chinese drug and diagnostics firm, had cautioned that the new test kits that promise to detect the coronavirus in a few minutes may not be as accurate as conventional kits, Bloomberg reported.
The kits, an ICMR official told BloombergQuint on the condition of anonymity, will be used after due checks, adding they’d be used to narrow down search results when dealing with clusters where the number of people infected by the virus may be higher. Negative samples would be tested again after 10 days, the person said.
More than 150 firms are willing to offer test kits to India, the official said. Besides, National Institute of Virology in Pune has given approval to seven companies that don’t have certification from the U.S. FDA or CE-IVD, according to ICMR.