Experts have raised serious concerns and cautioned that these unapproved testing kits may produce faulty or fake results
At a time when the government is facing difficulties in battling and containing the spread of coronavirus, self-initiated import of unauthorized testing kits by some public representatives has created another public health issue in the country, according to the health authorities.
Although these public representatives term their actions as a “humanitarian cause,” health authorities have warned that such actions could be “self-destructive” for the government’s fight against the Covid-19 pandemic.
Experts have raised serious concerns and cautioned that these unapproved testing kits may produce faulty or fake results, which could instead fuel the spread of the virus if used widely, instead of restraining it and saving patients.
Many have also raised questions on how these kits were being brought into the country without approval from the country’s health authority in view of the standards set by the World Health Organization (WHO).
Currently, there are two kinds of testing kits available for identifying Covid-19 virus, Real Time PCR and Rapid Test. Bangladesh has been using only Real Time PCR as Rapid Test kits are yet to receive WHO approval.
“Only the Real-Time Test Kit is allowed for testing coronavirus infection in the country, other such kits are yet to be approved,” Directorate General of Drug Administration (DGDA) Director General Maj Gen Md Mahbubur Rahman told the Dhaka Tribune.
Why unauthorized testing kits can be “self-destructive”
The government imported Real Time PCR kits for Covid-19 virus detection soon after the coronavirus pandemic began. Bangladesh also received Real Time PCR kits through donations from the World Health Organization, Jack Ma Foundation and Alibaba Foundation, and few other organizations.
“The Real Time PCR can detect infection by identifying the RNA (ribonucleic acid) of the virus. Therefore, if the RNA is detected, the presence of the virus is confirmed,” said Prof Dr Saif Ullah Munshi, chairperson of Department of Virology of Bangabandhu Sheikh Mujib Medical University (BSMMU).
On the other hand, Rapid Test does not detect the virus directly. It rather detects antibody (protein produced in the blood to fight diseases by attacking and killing pathogens) and antigen (substance that causes the production of antibodies in the body).
“Basically, we can detect antibodies using the Rapid Test system, not the virus itself,” Dr Saif Ullah Munshi added.
“Therefore, it the Rapid Test kit detects antibody for the virus, it means there is a virus inside the patient’s body as the antibody was produced against that specific virus. It indirectly provides the result.”
But, there are some risks involved with this Rapid Test method, he added.
“The body takes 5 to 7 days to produce the antibody after being infected by a pathogen. So, if a person takes the test before that period, the results can show that the person is not infected. We call this false negative,” he added.
“It could produce 95% to 99% accurate results, if the kit is of very high standard.”
However, using the Rapid Test method can become “self-destructive” in times of a global pandemic.
“If the tests go wrong, it would show positive even if it is negative, and vice-versa. That would be turn out to be misdiagnosis.”
Gazipur mayor leading kit imports
Few public representatives, most of them from ruling Awami League, have imported these Rapid Test kits from China and have begun distributing these across the country.
Gazipur City Corporation Mayor Mohammad Zahangir Alam has probably imported the most of these unauthorized testing kits under self-financing.
He has already imported 50, 000 Rapid Test kits and also provided 15,000 PPEs (personal protective equipment). He also bought 100,000 more testing kits, which are now in China.
He himself carried the kits from China to Bangladesh by two “special flights.”
“I have a friend there who has a hospital. I have collected these from that hospital,” Zahangir told Dhaka Tribune.
However, these kits have already been distributed to different hospitals in Gazipur, Dhaka, and few other districts and municipalities.
Of them, Dhaka Tribune came to know that 25 kits have been distributed to Bera Municipality and 200 for Natore’s Singra upazila, a constituency under Zunaid Ahmed Palak, who is also state minister for the Ministry of Information and Communication Technology (ICT).
“I saw China’s success and that is why I followed them. There are about 190 hospitals and 400,000 citizens in Gazipur, and they have nothing to fight against this coronavirus,” Zahangir said.
Asked on whether he took approval for importing the kits, he said: “I need 90 days to receive the government approval for the kits. But within that time, people will vanish.”
Although Zahangir refused to disclose the name of the producing company of these Chinese kits, he said: “Each of these kits cost some $8 to $10. It is famous in China. If somebody has suspicion on the effectiveness of these kits, they can examine it.”
Asked why he imported the kits when the government does not authorize Rapid Test kits, Zahangir replied: “Which one comes first? Saving lives or following the law? I believe saving lives should come first.”
He also claimed that the kits can produce results with “99% accuracy.”
Meanwhile, Pabna’s Bera upazila Municipality Mayor Abdul Baten has also collected few testing kits from Gazipur City Corporation Mayor Mohammad Zahangir Alam.
“I saw him on television distributing the kits. Later, I contacted him and he asked me to send someone to collect the kits from him,” Abdul Baten told the Dhaka Tribune.
When asked whether he was aware that the kits were unauthorized, he said, “I am no doctor. I just brought these kits and forwarded them to doctors.”
Bera Upazila Health Complex’s Health and Family Planning Officer Dr SM Milon Mahmud received the kits from Abdul Baten.
“I received just 25 kits, and tested on two patients with coronavirus symptoms. Their samples were tested negative at the IEDCR. We also got the same result here.”
He, however, was aware that these kits were unauthorized.
Mentioning that they received no directions regarding the use of these kits, he said: “We are using these as people are now in panic.”
Who will oversee the problem?
Questions remain on how these unauthorized kits were allowed to enter the country and distributed bypassing government authorities and law enforcement agencies.
“The kits they (public representatives) have imported do not have our approval, as we would only approve them after checking the quality. What they are doing is not the right procedure to import,” Directorate General of Drug Administration (DGDA) Director General Maj Gen Md Mahbubur Rahman.
Mentioning that the Directorate General of Health Services (DGHS) was responsible to check whether unauthorized testing kits were being used, the DGDA chief further added: “We just check the quality of the kits, provide them with a NOC (No Objection Certificate) and approval for importing them into the country.”
Contacted, DGHS Additional Director General Prof Saniya Tahmina said: “It is not the DGHS’s responsibility to oversee what someone is binging into the country. We can only check whether the kits are working properly, if we are asked to do so.”
“DGDA should oversee whether the kits being imported have maintained the standards,” she added.
“It’s wrongful if the import has been made without declaration.”
Government evaluating Rapid Test kits
Although health authorities remain doubtful regarding the use of Rapid Test system, the government has been considering approving the method considering the current coronavirus situation in the country.
In this case, quality and accuracy of those kits must be maintained.
“We could not detect it (coronavirus) with Rapid Test in acute level. As we do not have the capacity to test 80 million people out of 170 million, that’s why we are thinking of approving the rapid test kits,” Prof Saniya Tahmina said.
As a part of it, the government has allowed Ganashasthaya Kendra to produce Rapid Test kits in the country, but it would be upon government’s decision if they would be finally approved.
Mohib Ullah Khondoker, managing director at the Gonoshasthaya-RNA Biotech Limited, earlier said that they will hand over their kits to the DGDA after final trials.
"The DGDA will then send the kits to the World Health Organization (WHO). After getting approval from the WHO, we can go for mass production," said Mohib.
GK is eying to keep the production cost of a kit within Tk200 so that a diagnosis can be done at a cost of Tk300-350.
“Once they finish the final trials of the kits, only then we can say whether they can be used or not,” Prof Saniya Tahmina said, adding: “If anyone wants a chance to produce these (Rapid Test kits), we should also give them a chance.”