Indian Council of Medical Research-National Institute of Virology, Pune, India.
Division of Epidemiology and Communicable Diseases, Indian Council of Medical Research, New Delhi, India.
Front Public Health. 2023 Nov 13;11:1274508. doi: 10.3389/fpubh.2023.1274508. eCollection 2023.
The Indian Council of Medical Research has set up a nationwide network of 28 laboratories for simultaneous surveillance of influenza virus and SARS-CoV-2 in ILI/SARI patients, using an in-house developed and validated multiplex real-time RTPCR assay. The aim of this study was to ensure the quality of testing by these laboratories by implementing an external quality assessment program (EQAP).
For this EQAP, a proficiency test (PT) panel comprising tissue-culture or egg-grown influenza virus and SARS-CoV-2 was developed. The PT panel was distributed to all the participant laboratories, which tested the panel and submitted the qualitative results online to the EQAP provider. The performance of the laboratories was evaluated on qualitative criteria but cycle threshold (Ct) values were also gathered for each sample.
On a qualitative basis, all the laboratories achieved the criteria of 90% concordance with the results of the PT panel provider. Ct values of different samples across the laboratories were within ≤ ±3 cycles of the corresponding mean values of the respective sample. The results of this EQAP affirmed the quality and reliability of testing being done for simultaneous surveillance of influenza virus and SARS-CoV-2 in India.
印度医学研究理事会设立了一个由 28 个实验室组成的全国性网络，用于对 ILI/SARI 患者中的流感病毒和 SARS-CoV-2 进行同步监测，使用的是内部开发并经过验证的多重实时 RT-PCR 检测方法。本研究旨在通过实施外部质量评估计划（EQAP）来确保这些实验室的检测质量。
为了进行这项 EQAP，开发了一个由组织培养或鸡胚培养的流感病毒和 SARS-CoV-2 组成的能力验证（PT）试剂盒。PT 试剂盒分发给所有参与实验室，由他们对试剂盒进行检测，并将定性结果在线提交给 EQAP 提供方。实验室的性能根据定性标准进行评估，但也收集了每个样本的循环阈值（Ct）值。
在定性方面，所有实验室都达到了与 PT 试剂盒提供方的结果 90%一致性的标准。不同实验室的不同样本的 Ct 值与相应样本的平均值相差不超过 3 个循环。这项 EQAP 的结果证实了印度同时监测流感病毒和 SARS-CoV-2 所进行的检测的质量和可靠性。
