Performance Evaluation of Multi-Drug Rapid Test for Rapid Detection of Multiple Drugs and Drug Metabolites in Human Blood Samples

Abstract

Objective: The Multi-Drug Rapid Test Cassette, developed by Hangzhou AllTest Biotech Co., Ltd, is a rapid chromatographic immunoassay designed for the qualitative detection of multiple drugs and drug metabolites in human whole blood, serum, or plasma. It aims to simultaneously detect various abused substances, including Amphetamine (AMP), Barbiturates (BAR), Benzodiazepines (BZO), Buprenorphine (BUP), Cocaine (COC), Cannabis (THC), Methadone (MTD), Methamphetamine (MET), 3,4-Methylenedioxymethamphetamine (MDMA), Morphine (MOP/OPI), Propoxyphene (PPX), Tricyclic antidepressants (TCA), Oxycodone (OXY), 2-Ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine (EDDP), Cotinine (COT), Tramadol (TML), Fentanyl (FYL), 3,4-Methylenedioxy pyrovalerone (MDPV), Synthetic cannabinoids(K2), Phencyclidine(PCP), Ketamine(KET), Lysergic acid diethylamide(LSD), 3,4-Methylenedioxyamphetamine(MDA), Acetaminophen(ACE), Ketamine(CAT), 6-Monoacetylmorphine (6-MAM), Zolpidem (ZOL), AB-PINACA (ABP/K3). Therefore, the present research was done to evaluate the diagnostic performance of this test. Material and Method: In this study, the accuracy, precision, and sensitivity of the drug testing methods were assessed. Approximately 100 specimens of each drug, obtained from previous drug screening tests, were tested. The results were compared to confirmatory analysis using GC/MS, and the accuracy of the testing was determined based on the comparative classification results. The evaluation of precision included measuring the consistency of measurements within a single run, between different runs, and among different operators, using the AllTest multi-drug detection tool across three different hospitals and three different batches. To evaluate the sensitivity of the detection method, various concentrations of drugs were added to a pool of whole blood, serum, or plasma without any drugs. The positive and negative results obtained from the testing were analyzed to assess the method’s ability to detect drugs at different concentrations. Results: In this study, we evaluated the performance of the Multi-Drug Rapid Test Cassette developed by Hangzhou AllTest Biotech Co., Ltd. The results demonstrated excellent performance of the test in terms of accuracy, sensitivity, and precision. Conclusion: The Multi-Drug Rapid Test Cassette developed by Hangzhou AllTest Biotech Co., Ltd exhibited reliable detection of multiple drugs and drug metabolites, providing trustworthy results for drug abuse screening. These findings have significant implications for drug control and monitoring, as well as supporting the broad application of this test in clinical and legal settings.