Perspective: Covid-19 tests in India can cost low and will help widen the net to get realistic picture

India, despite being number two in population (1380 million), was considered fortunate in Covid-19 as it had advantage of learning from the successes and failures of several countries and two months lead time for preparedness. Our bad luck- India's fortune was short-lived, as it climbed the Covid-19 graph from 25th rank on March 25 to 7th on May 31. With stiff rise in daily detection to around 10000 (8%) Covid-19 infections in average 120000 samples tested daily. India is slated to reach 6th today and 4th position next week bypassing UK and Spain, to remain below USA, Brazil and Russia. Despite the widely accepted WHO diktat of March 16 that "We have a simple message to allcountries - test, test, test".  India is low in testing due to policies.

No, doubt, India has come a long way from 35 tests per million as on 24th March and for which the commendable efforts taken by Indian Council for Medical Research (ICMR) and its network of authorized laboratories must be appreciated. At cumulative 4242,718 tests as on June 4, India has done 3077 tests per million population; which is less than 6% tests of those countries above us in numbers, barring Brazil. 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 are governed centrally.

Any infection like Covid-19 needs to be tackled with four Ts in a full cycle: Test-Trace- Track-Test. Mass-testing requires simpler tests. The only tests available in India are highly technical and costly tests- Reverse Transcriptase Polymerase Chain reaction (RT-PCR). Globally, available tests for Covid-19 are: molecular- PCR done on swab drawn from naso-pharynx or throat and serology tests - Enzyme Linked Immuno-sorbent Assay (ELISA). ELISA are Rapid Antibody Test done on whole blood or conventional ELISA that requires equipment and done on blood/serum samples, but none available for wider use.

Prohibitive cost of Rs. 4500/-, stringent condition of personal examination by doctor and other government restrictions are impediments, people face for doing tests. At public facilities they face inconvenience and often denial of services. In fact as per Government of India order of March 21, cost per test of Rs.4500/- at large private laboratories, was based on preliminary PCR Rs.1500/- for suspect cases and confirmatory PCR Rs.3000/-. Generally people as well as healthcare professionals are unaware of this technical glitch in wording. The Ministries of Health and Health Research are well aware of this but preferred to ignore. That direction is reproduced from the link:

The designated private laboratories are doing only a single PCR, but they never revised the cost and thus kept minting money in this daily market size of Rs. 20 crore business and profit margin of 300% in times of unprecedented humanitarian crisis. Those labs have no time for processing other tests. Whereas 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. They are physically and economically inconvenienced in addition to being harassed with treatments getting deferred. 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 headlines for being first Indian test and that too below Rs.100 per test. ICMR fixed the threshold cost of Rs.700-1100 per test for purchase of RT-PCR kits. Usually, the commercial costs in such high-end tests are double the reagent cost, so the indicative cost should have been Rs.1400-2200.

While recommending target cost of Rs.4500/- per test to be charged by private laboratories, the Ministry also stated "However, ICMR encourages free or subsidized testing in this hour of National Public Health Emergency". Telangana and Tamil Nadu states had fixed Rs.2500/- per test, but Maharashtra and Brihan-Mumbai Municipal Corporation (BMC) pay Rs.3500/- and private hospitals and individuals left to pay Rs.4500/-. There is neither any discount nor it is part of any package of tests. There is no marketing cost involved, so pure cost of Rs.4500/- per test is way too high. On May 25, ICMR issued a soft letter to states to renegotiate the cost, but refused to give lower threshold.

There has been increase in importance and demand of Rapid tests. If IgG is positive, that confirms immunity to Covid-19. Total 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. ICMR fixed the target price of Rs. 600/- per test. The initial lot of Raid Test kits, have been imported from two Chinese companies; which were blacklisted on April 27 by ICMR due to inferior quality. That was also mired in controversy as well as corrupt practices in buying Rs.225 worth Chinese kit at Rs.600/- and is subject matter of larger investigation. We have not heard if any action was indeed taken against anyone on this large scale bungling. States of Jharkhand and Telangana have widely used Korean rapid tests bought at Rs.337/-. Covid-19 is probably the only infection where the target price is at high threshold and both target costs raises suspicion, as they were halved by ardent negotiators. On May 30, ICMR released statement appealing states on using its IgG ELISA tests widely as an epidemiological tool. Ideally combined IgM-IgG ELISA tests with (early=IgM and delayed=IgG antibodies) should have been recommended. More so this ELISA kit gives qualitative result (positive or negative), but does not give quantitative results to show the level of antibodies. For convalescent Plasma Therapy we need higher level of antibodies in titre of 1:1000 or more.

What should be done?

1) The Union Health Ministry should publish list of approved tests weather they are PCR based or ELISA and allow state governments and private sector to negotiate cost, procure and use it.

2) Health Ministry should immediately withdraw their ambiguously worded circular dt. March 21; which lead to large-scale squandering and reissue fresh circular with clarity and ICMR should modify May 25 circular with directions on recovery of excess amount charged by private labs.

3) Public and private hospitals should withheld 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.

4) Allow Rapid and ELISA tests to be used in private and public settings with the understanding that the results may not be part of statistics. All negative tests can be reported negative and positive tests can be referred to the approved centres for confirmation. 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.

Escalate testing, including pool-testing and be ready for challenges than suppressing the test demands and facts. Make the private-public partnership a reality to fight Covid-19.

References:

1. https://www.who.int/dg/speeches/detail/who-director-general-s-opening-remarks-at-the-media-briefing-on-covid-19---16-march-2020 

2. https://www.icmr.gov.in/pdf/press_realease_files/Testing%20Capacity_22%20May%202020_v3.pdf 

3. https://www.mohfw.gov.in/pdf/NotificationofICMguidelinesforCOVID19testinginprivatelaboratoriesiIndia.pdf

4. https://www.icmr.gov.in/pdf/press_realease_files/ICMR_PR%20_IgG_Elisa_30052020.pdf

5. https://www.icmr.gov.in/pdf/covid/kits/Antibody_based_tests_16042020.pdf

Dr. Ishwar Gilada is consultant in HIV and Infectious Diseases in Mumbai, is President AIDS Society of India and Governing Council Member, International AIDS Society. Email: gilada@usa.net

Disclaimer: The views expressed in the above article are solely those of the author/agency in his/her private capacity and DO NOT represent the views of Medical Dialogues.