Lot-to-Lot Variations in a Qualitative Lateral-Flow Immunoassay for Chronic Pain Drug Monitoring

[摘要] To the Editor:Recently, Algeciras-Schimnich et al. highlighted the lot-to-lot variability of a quantitative immunoassay and the failure of frequently used protocols to detect these variations (1). We have discovered that lot-to-lot variations also present an important issue in qualitative immunoassays used for chronic pain monitoring. These variations impact the reliability of these assays in clinical practice.Over 7 months, we analyzed a total of 1681 urine samples across 5 lots of the same CLIA-waived, lateral-flow immunoassay (ABMC RapidTOX®), according to manufacturer instructions. We chose this device based on its low cost, its high negative predictive value, and that it includes an assay for the use of buprenorphine. We also analyzed these samples by liquid chromatography-tandem mass spectrometry (LC-MS/MS) (2). Each lot of immunoassay was used to analyze a similar number of different urine samples (mean across 5 lots = 336, range 329–354) with a similar number of samples measured by each lot containing opiates (mean = 150, range 140–156), oxycodone (mean = 155, range 133–164), or methadone (mean = 73, range 70–78). As the comparative method, LC-MS/MS was deemed the gold standard and used to categorize samples that should …

[学科分类] 过敏症与临床免疫学