AccuBioTech Co., Ltd. [China]

CE mark Morphine (mor) rapid test is for the qualitative detection of morphine in human urine at a cut-off of 300 ng/mL.

INTENDED USE

One Step MOR Urine Test is a lateral flow, one-step immunoassay for the qualitative detection of morphine in human urine at a cut-off of 300 ng/mL. This product is used to obtain a visual, qualitative result and is intended for professional use. The assay should not be used without proper supervision and is not intended for over the counter sale to lay persons.

This assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas chromatogra­phy/mass spectrometry (GC/MS) has been established as the preferred con­firmatory method by the National Insti­tute on Drug Abuse (NIDA). Clinical consideration and professional judg­ment should be applied to any drug of abuse test result, particularly when preliminary positive results are indica­ted.

PERFORMANCE CHARACTERISTICS

Accuracy: The accuracy of One Step MOR Test  was evaluated in compari-son to a commercially available immu­noassay at a cut-off of 300 ng/mL. 120 urine samples, collected from pre­sumed non-user volunteers, have been tested by both procedures with 100% agreement.

In a separate study, 74 urine samples, obtained from a clinical laboratory where they were screened and con­firmed as positives by the commercially available immunoassay and GC/MS, were tested by One Step MOR Test . Of the 67 samples with morphine concentration from = 346 ng/mL, all were identified as positives by both methods (100%) agreement). Of the 7 samples with morphine concentrations from 201-264 ng/mL, all were identified positives by the commercially available immunoassay and all were identified as negatives by One Step MOR Test .

Reproducibility: The reproducibility of One Step MOR Test  was evaluated at 4 different sites using blind controls. Of the 60 samples with morphine con­centration of 150 ng/mL, all were de­termined negative. Of the 60 samples with morphine concentration of 600 ng/mL, all were determined posi­tive.

Precision: The precision of One Step MOR Test  was determined by con­ducting the test with spiked controls. The control at 150 ng/mL should give a negative result and the control at the 450 ng/mL should give a positive result.

Specificity: The specificity for One Step MOR Test  was tested by adding various drugs, drug metabolites, and other compounds that are likely to be present in urine. All compounds were prepared in drug-free normal human urine.

The following structually related com­pounds produced positive results when tested at levels equal to or greater than the concentrations listed below.

The following compounds were found not to cross-react when tested at concentrations up to 100 µg/mL

Acetaminophen, Acetone, Albumin, Amitri­ptyline, Ampicillin, Aspartame, Aspi­rin, Atropine, Benzocaine, Benzo­ylecgonine, Bilirubin, Caffeine, (+)-Chlor­pheniramine, (+/-)-Chlorphenir-amine, Chlorpromarine, Creatine, Des­oxyephetrine, Dexbromphenir-amine, Dexbromethorphan, 4-Dimethyl-amino­antipyrine, Dopamine, Doxylamine(+/-)-Ephe­drine, (-)-Ephedrine, (+)-Epi-nephrine, Erytromycin, Ethanol, Furo-semide, Glucose, Guaiacol Gly­ceryl ether, Hemoglobin, Hydromor­phone, Hydro-co­done, Hydroxytyra­mine, Imi­pramine, (+/-)-Iso­proterenol, Lidocaine, Na­loxane, Naltrexone Naphthalene acetic acid, (+)-Naproxen, (+/-)-Nor­ephedrine, 11-nor--D9-THC-9-carboxylic acid, Oxalic Acid, Oxyco­done, Peni­cillin-G, Pentamine, Pento­barbi­tal, Pheniramine, Phenobarbital, Phenothia­zine, L-Phenyl-ephrine, D-Pro-poxy­phene, Quinidine, Riboflavin, Seco­barbital, Sodium Chloride, Sulin­dac, Thioridazine, Trifluorper­azine, Tyra­mine, Vitamin C

morphine mor test