Kolkata: Microbiologists and labs engaged in testing Covid-19 samples in West Bengal have questioned the Indian Council of Medical Research (ICMR) after it implied that kits supplied to the state may have turned faulty because they were not stored or used correctly.
A total 10,800 ‘rapid testing kits’ and 4,700 ‘BGI RT PCR kits’ were withdrawn by the medical body from Bengal after they were found to be defective and gave inconclusive results.
Dr R Gangakhedkar, head of epidemiology and communicable diseases at ICMR, had pointed out that ‘BGI RT PCR kits’ should be stored at minus 20 degree Celsius for better results. He said the kits were approved by the United States Food and Drug Administration (FDA) and were of good quality.
"When a technician is working, he may take out a strip to run a second test. Where did he keep the test kit at that time? If he kept it at room temperature, then there is a possibility of results being faulty," Dr Gangakhedkar said.
But experts claimed that kits not being kept under prescribed conditions was impossible because all laboratories had kept the ‘defective kits’ under the same parameters as the first lot of ‘non-defective kits’ were kept - which gave good results.
Dr Suman Poddar, a microbiologist associated with Institute of Child Health, Kolkata, said, “Temperature is the basic thing which is maintained by all the laboratories. It is hard to believe that laboratories failed to maintain the temperature.”
He said the kits come with usage instructions and maintaining temperature is like a beginners’ job. “It is the basic thing in any laboratory and there is no rocket science in it. When we talk about the defective kits, here we have to track the cold chain from the supplier to receiver. We have to see whether the cold chain was broken midway or not.”
Elaborating on the cold chain, Dr Poddar said it should be examined that the PCR kits received from China were kept under ideal conditions of minus 18-23 degree Celsius with dry ice or not when being transported.
“Ideally, every ‘BGI RT PCR kits’ stock comes with a temperature logger. It continuously records the temperature. It is easy to find where and when the temperature was broken and not maintained as per the instruction.”
“While importing the kits from other countries, sometime it may happen that during Custom clearance the temperature was not maintained properly,” he added.
Highlighting more safety features, he said, there is an alarm system which sends beep sounds at the laboratory when temperature fluctuates. “We have to see whether the alarm was deactivated or not. It may be possible that the cold chain was broken while transportation. Ideally, in such cases the government receiver should have checked the temperature logger to ascertain whether there was a fluctuation in temperature or not,” he said.
On defective ‘Rapid testing kits’, he said, “These kit can sustain a temperature up to 20 degree Celsius. These kits are meant for on the spot resting and here the temperature sustainability is high. I think in case of ‘Rapid testing kits’ - there may be some manufacturing defects.”
Dr. Somnath Chatterjee, director of Suraksha Diagnostics, also said it is unlikely that the temperature was not maintained in case of keeping the RT PCR kits. “We are very particular about maintaining the standard procedure.” Suraksha Diagnostics is among the laboratories in Bengal which are engaged in COVID-19 testing.
Santanu Sen, the state secretary and immediate past national president of Indian Medical Association (IMA), accused the ICMR of giving lame excuses for the defective kits.
“Why can’t they simply admit that the kits were defective? If our labs failed to maintain the temperature, then how come there was no complaint from the kits and its results which was received in the first lot? I think it’s a lame excuse from him (Dr. R Gangakhedkar),” he added.
On Wednesday, West Bengal chief minister Mamata Banerjee had questioned critics, who blamed her for not taking adequate measures to fight COVID-19, and asked what they have to say on faulty kits the state received from ICMR.
Addressing a press conference at the state secretariat, Banerjee said systematic efforts were made to malign the image of Bengal in the last few weeks. “There are people who alleged that we are not doing enough testing. They spread misinformation about Bengal,” she said.
“The ICMR had supplied three types of COVID-19 test kits. They are ‘Rapid Testing Kits’, ‘BGI RT PCR kits’ and ‘Antigen Kits’. The ground realty is ‘Rapid testing kits’ and ‘BGI RT PCR kits’ were both withdrawn. As far as antigen kits are concerned, it is not being supplied to hospitals in Bengal. Presently, as on April 22, 2020, West Bengal has zero kits supplied from ICMR/NICED which can test a COVID patient as per ICMR recommendations,” she added.