Adapting Lot Quality Assurance Sampling to accommodate imperfect tests: application to COVID-19 serosurveillance in Haiti

Abstract

AbstractBackgroundLot Quality Assurance Sampling (LQAS), a tool used for monitoring health indicators in low resource settings resulting in “high” or “low” classifications, assumes that determination of the trait of interest is perfect. This is often not true for diagnostic tests, with imperfect sensitivity and specificity. Here, we develop Lot Quality Assurance Sampling for Imperfect Tests (LQAS-IMP) to address this issue and apply it to a COVID-19 serosurveillance study in Haiti.DevelopmentAs part of the standard LQAS procedure, the user specifies allowable classification errors for the system, which is defined by a sample size and decision rule. We show that when an imperfect diagnostic test is used, the classification errors are larger than specified. We derive a modified procedure, LQAS-IMP, that accounts for the sensitivity and specificity of a diagnostic test to yield correct classification errors.ApplicationAt Zanmi Lasante health facilities in Haiti, the goal was to assess the prior circulation of COVID-19 among healthcare workers (HCWs) using a limited number of antibody tests. As the COVID-19 antibody tests were known to have imperfect diagnostic accuracy, we used the LQAS-IMP procedure to define valid systems for sampling at eleven hospitals in Haiti.ConclusionsThe LQAS-IMP procedure accounts for imperfect sensitivity and specificity in system design; if the accuracy of a test is known, the use of LQAS-IMP extends LQAS to applications for indicators that are based on laboratory tests, such as COVID-19 antibodies.Key MessagesIt is imperative to account for the sensitivity and specificity of the diagnostic test in serosurveillance studies.For prevalence estimation and inference, adjustments for imperfect testing properties are available to researchers. However, no adjustments currently exist for the design of Lot Quality Assurance Sampling systems, resulting in invalid classification systems when used with an imperfect diagnostic test.When sensitivity and specificity of a diagnostic test is known, Lot Quality Assurance Sampling for Imperfect Tests should be used to determine the sample size and decision rule for a system as it will result in valid classification errors.