LAHORE: The Punjab government has raised certain objections over the use of Rapid Antigen Testing (RAT), recommended by the federal health ministry, and said the RAT kits are unregistered, unreliable and a wastage of time and resources.

The response came a few days after the federal government directed the provinces to commence RAT for diagnosis of Covid-19. It had also directed the provincial governments to procure the World Health Organisation-approved RAT kits to start the testing from Nov 15.

In response to the recommendations, the Punjab health authorities said the use of RAT kits was first taken up by the two top forums -- Corona Experts Advisory Group (CEAG) and the Technical Working Group (TWG) -- in September when a multinational pharmaceutical company approached the department for their use.

The CEAG observed that there were multiple technical and operational issues with the introduction of RAT on a large scale that needed to be considered before any widespread use. The Punjab health authorities pointed out some faulty results of the RAT kits.

“The RAT kits of a renowned company that is also supplying to the US were tested against 10 confirmed positive samples and it gave six negative and four positive results,” reads an official letter of the health department that it sent to the federal government through the chief secretary.

The health department further said the availability of quality RAT kits was a major problem.

“The availability of quality Ag-RDT kits (WHO prequalified or certified) is a big question since their wide use will lead to more players flooding the market. In that case the regulatory framework for ensuring provision of a quality product needs to be extensive and fully functional,” the letter added.

It further said that the use of the kits was recommended under certain conditions only, one of which was high demand/case load to meet the testing requirements, and Punjab is still performing within its capacity. The documented capacity is over 18,000 tests per day, while Punjab is performing 10,000 on average.

The RAT test is not used to decide about isolation or quarantine of a person, which is a significant limitation. According to the department, an asymptomatic patient testing negative on RAT must be offered a PCR test, thus further burdening the system as well as creating likely denials among the public for RT-PCR.

The additional cost of double testing will increase funding among the already limited resources, it said.

Similarly, non-availability of proper swab sticks for sample collection from nasopharynx added to the limitations to this test. “Most of the available sticks are wooden which are not suitable for nasopharyngeal swabs,” the department claims.

Nasopharyngeal sampling also requires extensive screening across the province which may not be possible to cover in a short time.

The CEAG and TWG have assessed the usability of RAT and not recommended it at this stage, the Punjab government said. The department further pointed out that there was no substantial cost disparity between RT-PCR and RAT to make the latter a viable option.

Multiple tests needed to be conducted for confirmation of cases. Given the lower specificity of RAT as compared to RT-PCR, the cost benefit, if any, will not be sufficient. “The cost of testing will increase since a positive RAT will still need to be confirmed with RT-PCR,” it said.

The Punjab government proposed to the federal health ministry to introduce RAT in selected hospitals where rapid kits and their utilisation could be appropriately managed and compared against PCR testing. “Ideal settings can be in A&E department; before surgical procedures or patients undergoing procedures like dialysis, C section, normal delivery, biopsies etc,” the health department said.

Punjab further suggested starting the pilot use of RAT in large scale in regions like the Islamabad Capital Territory in the first phase, which can provide a true reflection and benefits of the technology and also an idea about the acceptance by the healthcare system and patients.

“The said kits are yet to be registered with the Drug Regulatory Authority of Pakistan and even after registration, the procurement process requires an extended timeline,” reads the document.

Published in Dawn, November 12th, 2020