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Kerala Medical Institute develops Rt-PCR kit with higher accuracy
The Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST) in Kerala, an institute under the Department of Science and Technology has developed a multiplex RT-PCR kit, where the validation shows the kit has 97.3 per cent sensitivity and 100 per cent specificity in the Covid-19 detection. This means it is unlikely to show any false positives and has only a 2.7 per cent chance of showing a false negative. The Indian Council of Medical Research has validated the kit at the National Institute of Virology in Pune, and found it satisfactory. "The kit developed by the SCTIMST targets two SARS CoV2 genes: RdRp and ORFb-nsp14, and the human RNAse P gene as the internal control. The kit is based on multiplex Taqman chemistry, amplifying all three genes in a single reaction. The amplification time for the assay is 45 minutes, besides the time required for the RNA isolation from nasopharyngeal swab samples," the statement said. ORFb-nsp14 is one of the least mutated genes in Covid-19. Currently, there are no kits in the market having ORF-nsp14 as the target. The mutations on the commonly used S, R and N gene of the virus interfere with the result of an RT-PCR test. For example, the changes in the spike protein of B.1.1.7 (first found in the UK) resulted in the failure of probes for the S gene. The turnaround time using the kit developed by SCTIMST is also faster. A normal RT-PCR takes about five to six hours to be completed. Source: Khaleej Times AH
22 May 2021,17:28

DGDA disapproves GK’s antibody testing kit
Gonoshasthaya Kendra (GK) on Thursday night said the Directorate General of Drug Administration (DGDA) did not approve its GR Covid-19 antibody testing kit. In a press release, GK said the DGDA did not accept the recommendations of the Technical Committee of Bangabandhu Sheikh Mujib Medical University (BSMMU) and denied registration of the GR Covid-19 rapid antibody testing kit. The Gonoshasthaya Kendra described the DGDA’s decision as unfortunate at this emergency situation of the country. “We’ll make our next course of action (in this regard) public very soon,” it added. Earlier on June 17, BSMMU submitted its report on the GK’s antibody kit to the DGDA. BSMMU’s technical committee which conducted the performance study of the kit, headed by Prof Shahina Tabassum, prepared the final report on the trial saying it is possible to identify the infection of maximum 40 percent of the Covid-19 patients with the GK kit. The committee, however, said the kit can be helpful in tackling the corona situation. According to GK, its antibody kit can help identify whether people have been infected with coronavirus in the past, and the presence of antibodies or resistance power in their bodies. It will also help collect plasma of those who have recovered. On May 2, the BSMMU authorities formed a six-member committee with Prof Shahina Tabassum as its head to conduct the performance study of the testing kit. On March 17, Gonoshasthaya Kendra declared that they had developed a testing kit that can examine samples to detect Covid-19 within 15 minutes. On May 13, it submitted the samples of GR Covid-19 Rapid Dot Blot antigen kit to the BSMMU authorities for the performance trial. However, it requested BSMMU on June 3 to suspend the performance study of its coronavirus-testing antigen kit due to the detection of some inconsistencies in sample collection procedure. Earlier on April 30, the DGDA gave Gonoshasthaya the permission to get its Covid-19 rapid testing kits tested. The DGDA informed Gonoshasthaya that the performance study of the kits could be done either at the BSMMU or IEDCR. Source: UNB AH
26 Jun 2020,09:35

GK’s antibody kit ineffective: BSMMU
Bangabandhu Sheikh Mujib Medical University (BSMMU) found the antibody testing kit developed by Gonoshasthaya Kendra (GK) as ineffective in detecting coronavirus. “We've found the antibody kit of Gonoshasthaya Kendra ineffective to detect coronavirus,” BSMMU VC Prof Konak Kanti Barua told UNB on Wednesday. He said the committee formed to conduct the performance study of the kit, headed by Prof Shahina Tabassum, prepared its final report on the trial. The VC said the committee conducted the trial using 509 antibody kits of GK. “In their analysis, the committee found the kit dysfunctional to identify the virus.” He said it is possible to identify the infection of maximum 40 percent of the Covid-19 patients with the GK kit. "We performed the trial on a total of 509 patients’ samples. Only 11 percent of the patients were identified in the first week while 40 percent in the second week. So, how do we say this kit is effective?” Prof Konak Kanti said. He, however, said the kit can be helpful to tackle the situation. The VC said they have already submitted the report on the performance study of the antibody kit to the Directorate General of Drug Administration (DGDA). “They will now take decision on it.” According to GK, its antibody kit can help identify whether people have been infected with coronavirus in the past, and the presence of antibodies or resistance power in their bodies. It will also help collect plasma of those who have recovered. On May 2, the BSMMU authorities formed a six-member committee with Prof Shahina Tabassum as its head to conduct the performance study of the testing kit. On March 17, Gonoshasthaya Kendra declared that they had developed a testing kit that can examine samples to detect Covid-19 within 15 minutes. On May 13, it submitted the samples of GR Covid-19 Rapid Dot Blot antigen kit to the BSMMU authorities for the performance trial. However, it requested BSMMU on June 3 to suspend the performance study of its coronavirus-testing antigen kit due to the detection of some inconsistencies in sample collection procedure. Earlier on April 30, the DGDA gave Gonoshasthaya the permission to get its Covid-19 rapid testing kits tested. The DGDA informed Gonoshasthaya that the performance study of the kits could be done either at the BSMMU or IEDCR. Source: UNB AH
17 Jun 2020,18:06
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