Antigen Test Introduction: DGHS keeps on dragging its feet

The introduction of antigen tests for suspected Covid-19 patients still remains uncertain, as health officials are yet to start the process of procuring the kits, despite getting the nod from the government over a week ago.

The Directorate General of Health Services (DGHS) is supposed to invite prospective antigen kit producers or suppliers capable of meeting the desired standard. But as of yesterday, there was no notable progress in this regard.

"Two kits [supplied by two developers] are being tested at IEDCR. We have tested another one previously and are getting another one soon. Once the process ends, we will introduce the [antigen] tests [at public hospital settings]. No specific time can be given right now," Prof Meerjady Sabrina Flora, additional director general of the DGHS, told The Daily Star yesterday.

The delay left some healthcare experts sceptical about the government's intent to launch the rapid testing kit. They said it has been delayed from fears that it might bruise the government's pride in handling the contagion with limited testing through RT-PCR.

The health services division of the health ministry on September 17 approved the antigen rapid testing at public healthcare centres after months of bureaucratic exercises.

The decision came soon after Prime Minister Sheikh Hasina's recent public statement that the coronavirus pandemic might accelerate during the upcoming winter.

Bangladesh has so far relied on the RT-PCR tests -- considered the gold standard for Covid-19 detection -- ever since the pandemic hit the country in March. The country is ranked at the bottom in the world in terms of conducting Covid-19 tests considering its population of over 160 million.

Only one suspected case is being tested for approximately 100,499 people, shows a recent Institute of Epidemiology, Disease Control, and Research (IEDCR) data.

The decision to launch antigen testing was taken primarily to increase the testing capacity at district hospitals where RT-PCR facilities are not available and also at specialised hospitals to treat critical patients.

An antigen test reveals if a person is currently infected with a pathogen, and it involves taking a saliva sample. It can usually determine whether a patient is acutely infected and contagious within 15 minutes.

Although an antigen test is less accurate than a complete PCR analysis, the major advantages are quick results and the possibility to use it directly on site, according to experts.

Globally, only a few companies out of around a hundred have been able to develop rapid testing kits with proper efficacy and sensitivity and a few countries are using it. India is using antigen kits for massive testing.

On Monday, the World Health Organization (WHO) authorised antigen-based rapid diagnostic tests and announced it will make some 120 million tests available for low- and middle-income countries at a maximum of $5 per unit.

Initially, the government decided to use 3,000 antigen kits daily at a limited number of public hospitals. That will be increased to 10,000 in 10 specialised and 39 district hospitals where RT-PCR testing machines are not available, according to the "Proposal on Rapid Antigen Test" prepared by the health ministry that laid out the testing protocol.

"We have sent the proposal back. It includes the testing protocol -- who will be tested and when etc.," Prof Tahmina Shirin, director of the IEDCR, told The Daily Star on Sunday.

The DGDA has set 90 percent sensitivity and 95 percent specificity as the standard for the approval of any antigen kit, the proposal mentioned.

The Daily Star has obtained a copy of the proposal that also viewed that "not more than two or three" organisations in the world have the ability to fulfil the DGDA standard, which is similar to the USA's FDA.

URGENT NEED

Experts, however, stressed on the immediate launching of antigen-based rapid testing kits.

"[Using] rapid antigen kit is urgent to separate the suspected carriers of the virus easily. It will also greatly help non-covid-19 patients get treatment timely," Prof Ridwanur Rahman, an infectious disease specialist told The Daily Star on Sunday.

"If any kit shows 50 percent sensitivity, it means the kit will detect at least 50 percent of patients correctly and that will be great help in suppressing the virus' transmission."

He believes that the government should have permitted the use of Gonoshasthaya Kendra's rapid testing kits instead of ruling it out for not meeting their desired standard.

"When we have few options, we have to use what we have. Many African countries like Nigeria and Ivory Coast are using their own rapid testing technologies. If the [Gonoshasthaya] kits were okayed, at least 50 percent of the undetected cases could have been detected," he observed.

Prof Nazrul Islam, member of the National Technical Advisory Committee on Covid-19, told The Daily Star on Sunday that the Directorate General of Drug Administration (DGDA) -- who will give the no-objection certificate based on certain criteria -- may revisit the set of standards considering the reality of the situation and limited options.

"But there must be a testing protocol to take the best advantage of the rapid test kits," Prof Nazrul added.

DAILY COUNTS

Yesterday, 12,869 samples were tested across the country and 1,488 new infections were recorded. With the new infections, the total number of people infected is 3,62,043, according to a press release issued by the DGHS.

Twenty-six people died from Covid-19 in the country during the 24 hours till 8:00am yesterday, taking the death toll to 5,219.

The death rate stands at 1.44 percent while the total positivity rate stands at 18.72 percent, said the press release.