TCA Urine Strip

Specifications CE mark rapid diagnostic test kit

TCA rapid test is for the qualitative detection of Tricyclic Antidepressants in human urine

ONE STEO PCP URINE TEST

Catalog No.	Product Name	Specimen	Note
ABT-DOA-A54	TCA Urine Strip	Urine	CE
ABT-DOA-B54	TCA Urine Cassette	Urine	CE

  INTENDED USE One step Tricyclic Antidepressants (TCA) Test is a lateral flow, one-step immunoassay for the qualitative detection of TCA in human urine at a cut-off of 1000ng/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). Clinacal consideration and professional judgement should be applied to any drug of abuse test result, particulary when preliminary positive results are indicated.   PERFORMANCE CHARACTERISTICS Accuracy: One Step TCA Urine Urine Test was evaluated in comparison to a commercially available immunoassay at a cut-off of 1000ng/mL for TCA. 92 urine samples, collected from presumed non-user volunteers, have been tested by both procedures with 100% agreement. In a separate study, 70 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 TCA Test Cassette. Of the 70 samples with TCA concentration > 1000ng/mL, 69 were found to be positives by both methods (98% agreement). Reproducibility: The reproducibilitu pf One Step TCA Urine Test was evaluated at 4 different sites using blind controls. Of the 60 samples without TCA all were determined negatices. Of the 60 samples with a TCA concentration of 1500ng/mL, all were determined positive. Precision: The precision of One Step TCA Urine Test was determined by conducting the test with blind spiked controls. The control at 500 ng/mL should give a negative result and the control at 2000ng/mL should give a positive result. Specificty: The specificty for One Step TCA 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. The following structurally related compounds produced positive results when tested at levels equal to or greater than the concentrations listed below.   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. Bring the pouch to room temperature before opening it. Remove the test strip from the sealed pouch and use it as soon as possible. 2. With arrows pointing toward the urine specimen, immerse the test strip vertically in the urine specimen for at least 5 seconds. Do not pass the maximum line on the test strip when immersing the strip. Place the test strip on a non-absorbent flat surface, start the timer and and wait for the red line(s) to appear. The result should be interpret the 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