BZD Urine Strip

Specifications CE mark rapid diagnostic test kit

BZD(BZO) rapid test is for the qualitative detection of benzodiazepines(BZO) in human urine

One Step Drug of BZD test

Catalog No.	Product Name	Specimen	Note
ABT-DOA-A29	BZD Urine Strip	Urine	CE
ABT-DOA-B29	BZD Urine Cassette	Urine	CE
ABT-DOA-A70	BZD Saliva Strip	Saliva
ABT-DOA-B70	BZD Saliva Cassette	Saliva

  INTENDED USE One Step BZD Urine Test is a lateral flow, one-step immunoassay for the qualitative detection of benzodiazepines 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 BZD Urine Test was evaluated in compari­son to a commercially available immu­no­assay at a cut-off of 300 ng/mL for benzodiazepines (Oxazepam). 114 urine samples, collec­ted from presumed non-user volun­teers, have been tested by both pro­cedures with 100% agreement. Reproducibility: The reproducibility of One Step BZD Urine Test was evaluated at 4 different sites using blind controls. Of 60 samples without oxacepam all were determined negatives. Of 60 samples with oxacepam concentration of 600 ng/mL, all were determined positive. Precision: The precision of One Step BZD Urine Test was determined by con­ducting the test with blind spiked con­trols. The control at 600 ng/mL should give a positive result.

Concentration (ng/mL)	No Tested	Correct Result	% Correct  Result
0	50	50	100
600	50	50	100

Specificity: The specificity for One Step BZD Urine 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.   TEST PROCEDURE Review “Specimen Collection" instructions. Test cassette/strip, patient's, and controls should be brought to room temperature (20-30°c) prior to testing. Do not pouches until ready to perform the assay. 1. Remove the test cassette from its protective pouch (bring the device to room temperature before opening the pouch to avoid condensation of moisture on the membrane). Label the device with patient or control identification. 2. Draw the urine sample to the line marked on the pipette. Dipense 3 drops (or 120ul) into the sample well. Use a separate pipette and device for each sample or control. 3. Read result between 3 to 8 minutes after the addition of sample. Do not read result after 8 minutes.   INTERPRETATION OF RESULTS Negative: Two colored lines appear in the viewing window. The line in the test region (T) is the drug probe line; the line on the control region (C) is the control line, which is used to indicate proper performance of the device. The color intensity of the test line may be weaker or stronger than that of the control line. Positive: Only one colored line appears in the control region (C). The absence of a test line indicates a positive result. Invalid: No line appears in the control region. Under no circumstances should a positive sample be identified until the control line forms in the viewing area. If the control line does not form, the test result is inconclusive and should be repeated. Note: A very faint line in the test region indicates that the barbiturate in the sample is near the cut-off level of the test. These samples should be re-tested or confirmed with a more specific method before a positive determination is made. ABOUT US we have exported our in vitro rapid diagnostic test and lab equipment to over 50 countries. Our Aim: ——Let every family benefit from our convenient and reliable diagnostic products and services. ——Let our lab equipment be used in every laboratory of the world. Our Values on Quality: ——Delivers customer value in all in all projects, services and processes; ——Gives quality at least as much consideration as schedules and budgets when day-to-day choices need to be made; ——Drives QMS results to the bottom line in terms of defect reduction and financial benefits; ——Allocates resources to achieve quality execution.   Our product have got CE, ISO13485 & ISO9001 certification. If you need high quality product at competitive price, good after-sale service, good supply chain —— Please contact us without hesitation or visit our website at www.accubiotech.com