Abstract
Quick identification and isolation of SARS-CoV-2 infected individuals is central to managing the COVID-19 pandemic. Real time reverse transcriptase PCR (rRT-PCR) is the gold standard for COVID-19 diagnosis. However, this resource-intensive and relatively lengthy technique is not ideally suited for mass testing. While pooled testing offers substantial savings in cost and time, the size of the optimum pool that offers complete concordance with results of individualized testing remains elusive. To determine the optimum pool size, we first evaluated the utility of pool testing using simulated 5-sample pools with varying proportions of positive and negative samples. We observed that 5-sample pool testing resulted in false negativity rate of 5% when the pools contained one positive sample. We then examined the diagnostic performance of 4-sample pools in the operational setting of a diagnostic laboratory using 500 consecutive samples in 125 pools. With background prevalence of 2.4%, this 4-sample pool testing showed 100% concordance with individualized testing and resulted in 66% and 59% reduction in resource and turnaround time, respectively. Since the negative predictive value of a diagnostic test varies inversely with prevalence, we re-tested the 4-sample pooling strategy using a fresh batch of 500 samples in 125 pools when the prevalence rose to 12.7% and recorded 100% concordance and reduction in cost and turnaround time by 36% and 30%, respectively. These observations led us to conclude that 4-sample pool testing offers the optimal blend of resource optimization and diagnostic performance across difference disease prevalence settings.
Highlights
Identification and isolation of infected individuals is key to containing the COVID-19 pandemic [1]
Nasopharyngeal and/or oropharyngeal swabs samples from COVID-19 suspects were collected by trained healthcare workers in Viral Transport Medium (VTM) and transported at 2–8 ̊C to the Regional Virology Laboratory, All India Institute of Medical Sciences, Bhopal
While pools with more than one positive sample gave 100% concordance with individualized testing, the study suffered from the limitation of including relatively small number of pools with 1 positive sample
Summary
Identification and isolation of infected individuals is key to containing the COVID-19 pandemic [1]. The need to ramp up diagnostic capacity is more acute in such settings owing to the higher burden of cases. The second wave of COVID-19 infection experienced by several countries is a testimony that the threat of COVID-19 is far from over [3, 4]. This warrants development of strategies which diagnostic laboratories across the globe can adopt to promptly address the need for increased testing requirement. Advent of antigen and antibodybased tests can fulfill the requirements of rapid testing, their overall applicability is limited by sub-optimal diagnostic sensitivity [5,6,7]
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