The One-step Barbiturates Test is a lateral flow, one-step immunoassay for the qualitative detection of Barbiturates in human urine at a cut-off of 300ng/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.
The test kit should be stored refrigerated or at room temperature 2-30℃(36-86°F). Each device should remain in its sealed pouch for the duration of the shelf life of two years.
FOR IN-VITRO DIAGNOSTIC USE.
For professional use only
Urine specimens may be potentially infectious. Proper handing and disposal methods should be established.
Avoid cross-contamination of urine samples by using a new specimen collection container and specimen pipette for each urine sample.
Specimen Collection and Preparation
The One-Step Barbiturates Test is formulated for use with urine specimens. Fresh urine does not require any special handing or pretreatment. Urine samples should be collected such that testing may be performed as soon as possible after the specimen collection, preferably during the same day. The specimen may be refrigerated at 2-8℃ for 3 days or frozen at -20℃ for a longer period of time. Specimens that have been refrigerated must be equilibrated to room temperature prior to testing. Specimens previously frozen must be thawed, equilibrated to room temperature, and mixed thoroughly prior to testing.
strip: 1.When you are ready to begin testing, open the sealed pouch by tearing along the notch. Remove the test from the pouch.
2. Immerse the strip into the container with the arrow end pointing towards the container. Do not immerse past the MAX (maximum) line. Take the strip out after 8-10 seconds and lay the strip flat on a clean, dry, nonabsorbent surface (e.g., mouth of the serum container).
3.Wait 3-8 minutes and read result. Do not read results after 8 minutes.
1.Review “Specimen collection” instructions. Test device, patient’s samples, and controls should be brought to room temperature (20-30℃) prior to testing. Do not open pouches until ready to perform the assay.
2.Remove the test device 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 number.
3.Hold the dropper vertically and transfer 3 full drops of urine (approx. 0.15ml) to the specimen well (S) of the test device, and then start the timer. Use a separate pipette and device for each sample or control.
4.Read result between 3 to 8 minutes after the addition of samples. Do not read result after 8 minutes.
Interpretation of Results
Positive: Only one pink band appears on test region of the Cassette.
Negative: Two pink bands appear on test region of the Cassette.
Invalid: If without colored band appears on test region, this is an indication of a possible error in performing the test. The test should be repeated using a new device.
1.The assay is designed for use with human urine only.
2.A positive result with the tests indicates the presence of a drug/metabolite only and does not indicate or measure intoxication.
3.There is a possibility that technical and/or procedural errors as well as other substances or factors not listed may interfere with the test and cause false results. See SPECIFICITY for lists of substances that will produce positive result, or that do not interfere with test performance.
4.If it is suspected that the samples have been mislabeled or tampered with, a new specimen should be collected and the test should be repeated.
The precision of the One-Step Barbiturates Test was determined by conducting the test with spiked controls. The control at 150ng/ml gave negative results and the control at 450ng/ml gave positive results.
Device specificity was tested against compounds related to, or not associated with, barbiturates, prepared in drug-free, normal human urine.