Jain Vijaylakshmi, Sherwani Nikita, Monga Niza, Sahu Aparna
Viral Diagnostic Laboratory, Department of Microbiology, Pt J.N.M Medical College, Raipur (C.G.), India.
Department of Microbiology, Mahasamund Medical College, Mahasamund (C.G.), India.
Indian J Med Microbiol. 2023 Mar-Apr;42:34-38. doi: 10.1016/j.ijmmb.2022.12.015. Epub 2023 Jan 23.
The pandemic of SARS-CoV-2 or COVID-19 has hugely created an economic imbalance worldwide. With the exponential increase in the number of cases and to keep in check on the community transmission, there is high demand and acute shortage of diagnostic kits. The pooled-sample strategy turns out to be the promising strategy intended to determine the optimal testing for specimens with limited resources and without losing the test sensitivity and specificity. The study was performed with standard molecular biology graded lab equipment, FDA-approved COVID-19 RNA extraction, and SARS-CoV-2 tests kits.
The study aims to comparatively analyze the pooling strategy of the naso-oropharyngeal specimen sample and RNA extracted from the same patient samples in the pool of 3,5, and 8 with no significant loss in test usability. Another primary focus of the study was detection of low or borderline SARS-CoV-2 positives in the pooling strategy. A total of 300 samples (240 positives and 60 negatives) were tested for 3, 5, and 8 pools of specimen samples and RNA elutes.
The comparative analysis determined the sensitivity for three and five pool strategy to be above 98% and eight pool strategy to be 100%.
The RNA elutes pooling strategy concordance rate is better than that of specimen pooling with 100% specificity. Thus, in the substantial crisis of resources with the global pandemic, pooling approaches for SARS-CoV-2 can be practical in a low prevalence rate of 5%.
严重急性呼吸综合征冠状病毒2（SARS-CoV-2）或2019冠状病毒病（COVID-19）大流行在全球造成了巨大的经济失衡。随着病例数量呈指数级增长，为控制社区传播，对诊断试剂盒的需求极高但供应严重短缺。混合样本策略被证明是一种有前景的策略，旨在在资源有限的情况下确定对样本的最佳检测方法，同时不损失检测的敏感性和特异性。本研究使用标准分子生物学分级实验室设备、美国食品药品监督管理局（FDA）批准的COVID-19 RNA提取试剂盒和SARS-CoV-2检测试剂盒进行。
本研究旨在比较分析鼻咽拭子样本以及从同一患者样本中提取的RNA在3份、5份和8份混合时的混合策略，且检测可用性无显著损失。该研究的另一个主要重点是在混合策略中检测低水平或临界SARS-CoV-2阳性。总共对300个样本（240个阳性和60个阴性）进行了3份、5份和8份样本池及RNA洗脱液的检测。
比较分析确定3份和5份混合策略的敏感性高于98%，8份混合策略的敏感性为100%。
RNA洗脱液混合策略的符合率优于样本混合，特异性为100%。因此，在全球大流行导致资源严重短缺的危机中，对于SARS-CoV-2的混合检测方法在患病率低至5%的情况下可能是可行的。
