Allow all pathologists, microbiologists to conduct Rapid Antigen Testing: MAPPM tell Govt

Mumbai: Seeking permission for all qualified pathologists and microbiologists to conduct rapid antigen tests to help detect Covid-19 cases, the Maharashtra Association of Practicing Pathologists and Microbiologists has recently moved the Indian Council of Medical Research (ICMR) and the state government.

This comes in light of the fact that on June 22, State Health Secretary, Dr Pradeep Vyas had allowed rapid antigen tests for Covid-19 patients with severe symptoms, comorbidities, and pregnant women. However, ICMR later restricted the tests to government hospitals and private laboratories that are accredited by the National Accreditation Board for Testing and Calibration Laboratories (NABL).

"The reason for rejection being " requirement of NABL accreditation for private labs are as per ICMR advisory and we are bound to abide by them."

In this regard, the Association has now submitted to the apex medical research body and furnished suggestions regarding the present criteria prescribed by ICMR for Rapid Antigen testing and has sought to withdraw the clause of NABL accreditation for the Rapid Antigen test and permit the said test to Laboratories willing to do the test, where full-time Pathologists or Microbiologists are working and abiding by guidelines of ICMR and State Government.

Justifying its demand, the Association, in its letter has highlighted ICMR's content from a letter dated 01.07.2010 to all the states as;

" Since "test-track-treat" is the key strategy for early detection and containment of the pandemic, it is important to augment testing for SARS-CoV-2 in all parts of the country. This is the only way to detect the Infection early and prevent its spread. To ramp up testing in the Country."

The Association claimed that ICMR has so far approved a total of 1,049 public and private laboratories for COVID¬19 testing. Of this, 761 labs are in the public sector and 288 are in the private sector. Further, ICMR has also recommended the use of a rapid point-of-care antigen test kit for diagnosis and more such kits are being validated to increase the available options to the citizens.

However, it has been observed that in some States/ Union Territories(UT), the capacity utilization of the testing labs, particularly the ones In the private sector, is grossly sub-optimal. It is strongly advised that you should take all possible steps to ensure full capacity utilization of all COVID-19 testing laboratories in the State/UT.

They further claimed that it has also been observed that some states/UTs have mandated the need for a prescription from a Government doctor for making an individual eligible to undergo the COVID-19 test. In view of the increased load on government healthcare facilities, this mandatory requirement may at times pose an Impediment for an individual to get tested and lead to unnecessary delays. At this juncture, it is absolutely necessary to facilitate testing at the earliest by enabling all qualified medical practitioners including private practitioners to prescribe COVID test any Individual fulfilling the criteria for testing as per ICMR guidelines. In fact, ICMR strongly recommends that laboratories should be free to test any Individual in accordance with the ICMR guidelines and State authorities must not restrict an Individual from getting tested, as early testing will help in containing the virus and saving lives.

Explaining the intent of the letter and the insistence on NABL accreditation criteria for Antigen testing that are contradictory to each other, Dr Yadav wrote;

"The need of extensive testing, tracking, and treatment is rightly stressed. It has also suggested setting up camps and mobile vans to collect samples of all symptomatic individuals and their contacts and use of Rapid Antigen test. It is not possible to set NABL accredited laboratories in all nooks and corners of the country where there are Hot Spots."

Elaborating on the factual details, the doctors' body stated that in Maharashtra, the increase in COVID cases in rural areas is due to travellers only. The doctors can think of starting rapid antigen tests at inter-district Check posts. The test can further help in preventing the chance of transmission of the Coronavirus if the donor happens to be an asymptomatic carrier. Besides, many of the clinicians want Rapid antigen tests to be done but they don't have access to NABL accredited laboratories nearby.

Rapid Antigen Test is quick, simple, safe, and can be used as a point-of-care test in containment zones as well as hospitals and in preoperative settings. But the rider of NABL accreditation being mandatory is a major hurdle to ramp up testing and contain the SARS cov2 virus and treatment of Non-COVID ailments.The test is also known as Standard Q Covid-19 Ag detection, provides results in only 30 minutes, which helps decide further course of treatment for serious patients at the earliest.

The body further added that many non accredited pathologists laboratories are providing laboratory services required for the treatment of COVID positive patients admitted in the COVID center. Moreover, the majority of Corona Care hospitals are not NABH accredited.

It also claimed that in Mahasrhtra there are only 48 NABL accredited laboratories, the majority of them are located in metro cities like Pune, Bombay, Nagpur, Aurangabad. Many of the districts in the country don't have a single NABL accredited lab. This is because Many Pathologists and Microbiologists' don't want to go for accreditation just because NABL does not obey Hon. Supreme Court order dated 12.12.2017 and other laws of the land.

While there are almost 5000 Pathology Laboratories in Maharashtra in which MMC registered Pathologists / Microbiologists are supervising the process of testing, preparing, and certifying reports. These laboratories are distributed across the state including metro cities to municipal council areas at taluka places. All quality norms are taken care of. They are diagnosing diseases and on the basis of their reports which patients are being treated with favorable clinical outcomes.

Furthermore, it stated a thorough comparison between the NABL Accreditation and laboratory run under the supervision of MCI/ State Medical Council registered Pathologists/ Microbiologists as;

• In India, NABL Accreditation is a voluntary process. Going through 112 of NABL documents, which are the norms for the personnel in the laboratory/ signatory authority, keeps on changing and many times it was contradictory to Hon. Supreme Court order dated 12.12.2017 regarding certifying Pathology reports. So NABL itself is biased and does not obey the law of the land. Many laboratories initially accredited didn't apply for renewal.
• NABL accreditation is the only norm for quality and accurate reports: There are 761 ICMR approved COVID testing labs in the public sector, the majority of whom are not accredited by NABL. These non-accredited labs are also giving standard and quality reports. So NABL accreditation cannot be said to be the only criterion for quality and accurate reports. Otherwise, these laboratories in the public sector need to be stopped from functioning.

• Also Read: Pathologists Up Against MCI Decision Allowing Medical Msc To Sign Technical Lab Reports
  

The letter also drew attention towards the available modalities for testing. "While RT PCR Is the gold standard for diagnosis of COVID-19, ICMR has recently approved the use of a point-of: care rapid antigen test for early detection of COVID-19. The test is quick, simple, safe, and can be used as a point-ale-care test in containment zones as well as hospitals, as per criteria specified by ICMR for testing," it quoted.

In view of the above, the body requested that impediments, which restrict testing may be removed forthwith.

Further, to facilitate testing, the Association suggested that efforts should be made in 'campaign mode' by vetting up camps/using mobiles vans in high incidence areas to collect samples glall, symptomatic Individuals. as well as their contacts, and get those samples tested by using rapid antigen tests, "The positive Individuals should be treated according to the treatment protocol and the negative ones, should be tested, for RT-PGR"

Subsequently, considering the need of the hour in containing Pandemic, Dr Sandeep Yadav, President of the Association concluded by mentioning that refraining non-NABL accredited, Pathologists or Microbiologists run laboratories from conducting Rapid Antigen tests will be contradictory to the intentions of the govt. to contain SARS- CoV-2 and will be refraining common man from medical treatment and violation of the basic human right of health.

https://medicaldialogues.in/pdf_upload/pdf_upload-131441.pdf

Read Also: ICMR defends timeline for coronavirus vaccine trials