Multiple category-lot quality assurance sampling: a new classification system with application to schistosomiasis control.

backgroundOriginally a binary classifier, Lot Quality Assurance Sampling (LQAS) has proven to be a useful tool for classification of the prevalence of Schistosoma mansoni into multiple categories (≤10%, >10 and <50%, ≥50%), and semi-curtailed sampling has been shown to effectively reduce the number of observations needed to reach a decision. To date the statistical underpinnings for Multiple Category-LQAS (MC-LQAS) have not received full treatment. We explore the analytical properties of MC-LQAS, and validate its use for the classification of S. mansoni prevalence in multiple settings in East Africa. METHODOLOGY: We outline MC-LQAS design principles and formulae for operating characteristic curves. In addition, we derive the average sample number for MC-LQAS when utilizing semi-curtailed sampling and introduce curtailed sampling in this setting. We also assess the performance of MC-LQAS designs with maximum sample sizes of n=15 and n=25 via a weighted kappa-statistic using S. mansoni data collected in 388 schools from four studies in East Africa. PRINCIPLE

findingsOverall performance of MC-LQAS classification was high (kappa-statistic of 0.87). In three of the studies, the kappa-statistic for a design with n=15 was greater than 0.75. In the fourth study, where these designs performed poorly (kappa-statistic less than 0.50), the majority of observations fell in regions where potential error is known to be high. Employment of semi-curtailed and curtailed sampling further reduced the sample size by as many as 0.5 and 3.5 observations per school, respectively, without increasing classification error. CONCLUSION/SIGNIFICANCE: This work provides the needed analytics to understand the properties of MC-LQAS for assessing the prevalance of S. mansoni and shows that in most settings a sample size of 15 children provides a reliable classification of schools.