How Covid-19 testing is mismanaged
India climbed the world Covid-19 graph of number of infections from rank 25 on March 25 to rank 7 on May 31. We see a stiff rise in daily detection of Covid-19 positives to over 8,000, or around 7% of the average 1,10,000 samples tested daily. India is slated to reach the fifth position next week, overtaking Italy and Spain, to remain below USA, Brazil, Russia and UK. Despite the WHO direction of March 16, spelt out in these words, "we have a simple message to all countries - test, test, test", India is low in testing due to its policies. Further, testing is mired in a huge policy hole that is working against interest of patients.
At cumulative 39,66,075 tests as on June 2, India has done 2,876 tests per million population. This is less than 6% tests of those countries above as also just below us in numbers, barring Brazil. No, doubt, India has come a long way from 35 tests per million as on 24 March. The fear that the moment we escalate testing, we will be number one globally, may be keeping us back and that may be the reason tests and numbers are governed centrally.
Any infection like Covid-19 needs to be tackled with four Ts in a full cycle: Test-Trace-Track-Test.
Any infection like Covid-19 needs to be tackled with four Ts in a full cycle: Test-Trace-Track-Test. Mass-testing also requires simpler tests in its armamentarium. The mainstay of Covid-19 tests available in India so far has been the highly technical and costly tests called - Reverse Transcriptase Polymerase Chain reaction (RT-PCR).
In India, the cost of a PCR test is Rs. 4,500 in the private sector along with stringent conditions like the need for a personal examination by doctor and other government restrictions. These work as impediments people face for tests in the private sector. At public facilities, they face inconvenience and often denial of services. Further, as per the Government of India order of March 21, cost per test was of Rs.4,500 at large private laboratories, but this was not supposed to be a flat fee at all. The exact words and direction of the Indian Council for Medical Research (ICMR) guidelines in this regard read as follows: “…maximum cost for testing sample should not exceed Rs. 4,500. This may include Rs.1,500 as screening test for suspect cases, and an additional Rs.3,000 for confirmation test. However, ICMR encourages free or subsidised testing in this hour of national public health emergency.”
Our knowledge is that although the designated private laboratories are doing only a single PCR, which should cost only Rs.1,500, they have always charged Rs. 4,500 as standard fixed fee. This is unconscionable; it is minting money in a market which has daily “business” of Rs. 20 crore and an obscene profit margin of 300%. These labs have no time for processing other tests. A majority of Covid-19 tests done in private labs are from private hospitals, besides some from mandatory tests on pregnant, dialysis, chemotherapy and pre-surgery patients who are defenseless. Worse, patients are physically and economically inconvenienced in addition to being harassed with treatments getting deferred on the demand for these tests before hospitals admit them.
Although the designated private laboratories are doing only a single PCR, which should cost only Rs.1,500, they have always charged Rs. 4,500 as standard fixed fee.
As on May 25, ICMR evaluated 83 RT-PCR kits and found 35 to be satisfactory. Of these, 20 are from Indian companies, including Pune’s My Labs that shot into the headlines for being the first Indian test at ultra-low cost. ICMR fixed the threshold cost of Rs.700-1,100 per test for purchase of RT-PCR kits by publicly-run laboratories. Usually, the commercial costs in such high-end tests are double the purchase cost of reagent, so the indicative cost should have been Rs.1,400-2,200. But the recommended maximum of Rs. 4,500 per test has become the norm in the private sector, adding to the burden faced by people in times of a pandemic.
Telangana and Tamil Nadu states had fixed up Rs.2,500 per test, but Maharashtra state and Brihan-Mumbai Municipal Corporation pay Rs.3,500 and private hospitals and individuals are left to pay Rs.4,500. On May 25, ICMR issued a soft letter to States to renegotiate the cost, but refused to give a lower threshold cost. We don’t know why ICMR could not drive the price down when others are able to do so.
There has now been an increase in importance and demand of rapid tests, or Enzyme Linked Immuno-Sorbent Assay (ELISA), which tests for antibodies to COVID-19. While a positive PCR test indicate presence of virus, a positive ELISA test indicates that the person tested is fighting the virus (IgM positive) or was infected in the past and has acquired immunity (IgG positive).
There has now been an increase in importance and demand of rapid tests, or Enzyme Linked Immuno-Sorbent Assay (ELISA), which tests for antibodies to COVID-19.
Till date, a total of 23 antibody based rapid tests have been validated at National Institute of Virology (NIV), Pune, and the ICMR has approved 14. Nine of these kits are manufactured in India. The target price per test was fixed at Rs. 600 by the ICMR. The initial lot of Raid Test kits have been imported from two Chinese companies, which ICMR blacklisted on April 27 due to inferior quality. That was also mired in controversy as well as corrupt practices in buying Rs.225 worth of Chinese kit at Rs.600 and is subject matter of larger investigation. We have not heard of action, if any, against anyone involved in this large-scale bungling.
The States of Jharkhand and Telangana have widely used Korean rapid tests bought at Rs.337 per test. Covid-19 is probably the only infection where the target price is fixed at high threshold and both target costs raises suspicion, as they were quickly halved by ardent negotiators. On May 30, ICMR released a statement appealing to the States to using its IgG (longer term antibodies present) ELISA tests widely as an epidemiological tool. Ideally, combined IgM-IgG ELISA tests with should have been recommended. This ICMR recommended ELISA kit gives qualitative result (positive or negative), but does not give quantitative results to show the level of antibodies. But numbers are required if the recovered patient is to donate plasma for convalescent Plasma Therapy, which will need higher level of antibodies in titre of 1:1000 or more.
All public and private hospitals should withhold payments to private labs till they rationalise cost of PCR and refund excess amount charged, as this is not a time for huge profiteering.
At this stage, the least that the ministry can do is (1) publish a list of approved tests, weather they are PCR based or ELISA and allow state governments and private sector to negotiate costs, procure and use, (2) withdraw its ambiguously worded circular of March 21 which led to large-scale squandering of money and reissue fresh circular with clarity, (3) ICMR should similarly issue directions on recovery of excess amount charged by private labs. All public and private hospitals should withhold payments to private labs till they rationalise cost of PCR and refund excess amount charged, as this is not a time for huge profiteering. Refund should be also given to all clients, as private labs have their full details including Aadhar cards.
Similarly, we must allow Rapid and ELISA tests to be used in private and public settings even though these results are not included in government statistics, which count only PCR tests. All negative tests can be reported negative and positive tests can be referred to the approved centres for confirmation if that data is to be used in official statistics. This will ensure that the private sector medical profession getting involved as an asset to the government. If emergency service provider tests IgG positive, s/he can be redeployed in services, as they have developed immunity. We can also escalate testing, including pool-testing that reduces cost by 60-70% and be ready for challenges rather than suppressing the test demands and facts.
(Dr. Ishwar Gilada is a Consultant in HIV and Infectious Diseases, President AIDS Society of India and Governing Council Member, International AIDS Society)