Jumbangla Desk: The sensitivity of dengue test kit developed by Bangladesh Reference Institute for Chemical Measurements (BRICM) is not as expected and it is not an indigenous innovation either. This has been proven in multiple lab tests.
dengue
But it was selected as the best innovative initiative of the Ministry of Science and Technology in the fiscal year 2023-24 . At the government level, a project worth 145 crores has also been taken for the use of this kit.
However, the project did not go ahead as the government collapsed in the August student-crowd movement. A group of scientists led by BRICM Chief Scientific Officer Mala Khan claimed to develop the kit. On January 21, through the Ministry of Science and Technology, a letter was sent to the Ministry of Health to purchase this kit.
It has been learned that the then Science and Technology Minister Yafes Osman gave the Tk 145 crore project to Mala Khan, Chief Scientific Officer of BRICM, due to personal friendship.
Experts say that the quality of the kit is very important to get accurate results in the antigen test. Then the quality of the sample and what stage of infection is being tested—that is. False negatives are more likely to occur in substandard kits or poor sample quality. This mistake can lead to death of the patient in many cases.
The Directorate of Medicines Administration (DGDA) has granted drug license for BRICM's kit and approval for commercial production of the kit. However, there are doubts about its quality assurance.
Prior to approval, the kit was tested for sensitivity in the labs of the National Institute of Laboratory Medicine and Referral Centre, National Institute of Preventive and Social Medicine (NIPSOM) and International Udramaya Research Centre, Bangladesh-ICDDRB. In the evaluation report of these labs, the sensitivity of the kit was not as expected, but Mala Khan declared that it was 100% proven. Recently the reports have come in the hands of Kal Kantha.
Talking to the lab staff, it is known that a maximum of 10 samples are tested for dengue positive and negative. Among these, the sensitivity of the kit for positive detection was somewhere between zero percent and somewhere around 56 percent. A letter was given in this regard because it was unclear somewhere.
As a rule, the quality of such kits will have three types of samples - high, medium and low. The company provides high positive or high negative quality samples for lab testing, which by no means guarantees a good quality kit. Apart from this, a minimum of 200 samples were supposed to be tested, but only 10 were done.
What was known in the results of the lab
Director of the National Institute of Laboratory Medicine and Referral Center Professor Dr. Mohammad Shahed Ali Jinnah told Kal Kantha, 'We have seen that the sensitivity of this kit in positive detection is zero percent after testing five positive and five negative samples of BRICM. In case of negative detection, this rate is 40 percent. In other words, even a single sample tested with this kit could not be identified as positive. A maximum of 40 percent can be identified in the case of negatives.
Nipsom lab in charge assistant professor Dr. Fahmida Khanom told Kal Kantha that the sensitivity of the Abbott kit in the market is 80 percent, the sensitivity of the dengue check kit is 100 percent. In comparison, BRICM's kit has a very low sensitivity—only 66 percent. 57 percent in positive detection and 33 percent in negative detection.
On condition of anonymity, an ICDDRB official said that the detection of dengue positive was unclear. This increases the risk of technicians giving wrong results. Negative sample detection results in white spots, which confuses the user in interpreting the results.
Those concerned said that this type of antigen test is mainly used for virus detection. And the main function of virus detection is done by a type of protein part. The technology capability or lab needed to make it is not available in Bangladesh. This protein is brought from abroad. Raw materials also come from China. Apart from OMC, this work is done by several other organizations.
A BRICM official involved in the development of the kit said on the condition of anonymity that with the help of former Science and Technology Minister Yafes Osman, the drama of dengue kit development was arranged to get a project of Tk 145 crore. All the information that Mala Khan has presented in the media about the invention of the kit is baseless. The kit is not 100% effective in detecting dengue virus. Not even indigenously invented. Bringing raw materials from China and buying domestic materials from the market has added. There is nothing new here.
According to BRICM sources, the raw material for the kit is brought by the contracting company Shikdar Enterprises. The organization has been getting most of BRICM's work due to its closeness with Mala Khan. They are given the task even if they have no previous experience of bringing the raw materials of the kit.
Awal Shikder, leader of Shikder Enterprises, said, 'The raw material of the kit was brought from China under the guidance of scientific officer Mala Khan. My organization has no office. I do some work at the request of acquaintances. Mala Khan is my acquaintance.'
Mala Khan refused to comment on such allegations. Earlier, he told the media at various times that they started making kits from 2021. Submitted it to Bangladesh Medical Research Council (BMRC) in 2022. A clinical trial of the kit was later conducted between December 2022 and August 2023 at the National Institute of Laboratory Medicine and Referral Center.
Mala Khan led Mamudul Hasan Raju, Raisul Islam Rabbi, Javed bin Ahmed, Khandkar Sharif Imam, Mo Rahat, Nafisa Chowdhury and Md. A group of scientists including Sohail developed the kit. At that time it was claimed that the sensitivity of the kit was 100%. It did not report any errors.
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According to Mala Khan's statement at that time, according to the guidelines of the World Health Organization, every step has been taken in accordance with the established norms of research and testing. Bangladesh Medical Research Council - BMRC approved after reviewing all the data.
Shimul Mahmud
