COC Drug Urine Test Cassette
1. Intended Use
The COC Drug Urine Test Cassette is a rapid chromatographic immunoassay for the qualitative detection of cocaine metabolite, Benzoylecgonine in human urine at a cut-off concentration of 150ng/mL(customized). This assay provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.
2. Materials Provided
The COC Drug Urine Test Cassette contains the following items to perform the assay:
Disposable specimen droppers
3. Procedure of the Test
(1)Bring the pouch to room temperature before opening it. Remove the test device from the sealed pouch and use it as soon as possible.
(2)Place the test device on a clean and level surface. Hold the dropper vertically and transfer 3 full drops of urine (approx. 100μl) to the specimen well (S) of the test device, and then start the timer. Avoid trapping air bubbles in the specimen well (S).
(3)Wait for the red line(s) to appear. The result should be read at 5 minutes or up to 4 hours after test initiation.
4. Interpretation of Results
Negative: Two lines
Positive: One line (C)
The urine specimen should be confirmed with a more specific alternative method such as GC/MS, before a positive determination is made.
5. Analytical Sensitivity
A drug-free urine pool was spiked with Benzoylecgonine at the following concentrations: 0ng/mL, 75ng/mL, 112ng/mL, 150ng/mL, 187ng/mL and 225ng/mL. The result demonstrates 100% accuracy at 50% above and 50% below the cut-off concentration. The data are summarized below:
Eighty (80) of these clinical samples were also run using The COC Drug Urine Test Cassette by an untrained operator at a different site. Based on GC/MS data, the operator obtained a statistically similar Positive Agreement, Negative Agreement and Overall Agreement rate as the laboratory personnel.
Hangzhou Laihe Biotech Co., Ltd
Address: Room 521 Floor 5 & Floor 1,Building No. 2B,Tianhe High-Tech Park,No. 688,Bin'an Road,Changhe Sub-district,Binjiang District,Hangzhou City,Zhejiang Province,China