Abstract
Objectives
To obtain optimal immunoassay screening and LC-MS/MS confirmation cut-offs for opiate group tests to reduce false positive (FP) and false negative (FN) rates.
Methods
A total of 126 urine samples, −50 opiate screening negative, 76 positive according to the threshold of 300 ng/mL by CEDIA method – were confirmed by a full-validated in-house LC-MS/MS method. Sensitivity, specificity, FP, and FN rates were determined at cut-off concentrations of both 300 and 2,000 ng/mL for morphine and codeine, and 10 ng/mL for heroin metabolite 6-mono-acetyl-morphine (6-MAM).
Results
All CEDIA opiate negative urine samples were negative for morphine, codeine and 6-MAM. Although sensitivity was 100% for each cut-off; specificity was 54.9% at CEDIA cut-off 300 ng/mL vs. LC-MS/MS cut-off 300 ng/mL and, 75% at CEDIA cut-off 2,000 ng/mL vs. LC-MS/MS cut-off 2,000 ng/mL. False positive rate was highest (45.1%) at CEDIA cut-off 300 ng/mL. At CEDIA cut-off 2,000 ng/mL vs. LC-MS/MS cut-off 300 ng/mL, specificity increased to 82.4% and FP rate decreased to 17.6%. All 6-MAM positive samples had CEDIA concentration ≥2,000 ng/mL.
Conclusions
2,000 ng/mL for screening and 300 ng/mL for confirmation cut-offs are the most efficient thresholds for the lowest rate of FP opiate results.
RAPID URINE SCREENING FOR BACTERIURIA IN CHILDREN USING MICROBIOLOGY ANALYZER, COMBINING PHOTOMETRIC AND COHERENT FLUCTUATION NEPHELOMETRIC METHODS
