510K approved AMP COC THC MOP drug of abuse test cup
When free drug is absent from urine or at concentration lower than the urinary detection cut-off level, the pink-colored ,antibody-colloidal gold conjugate is free to bind to the immobilized drug conjugate pre-coated on the chromatographic membrane test region .Consequently ,a pink-colored band will form in the test region indicating a negative result .When drug is present in urine at concentrations at or exceeding the detection cut-off level, it will bind to limited epitopes on the pink-colored, antibody-colloidal gold conjugate , completely competing with drug conjugate in the test region .In such cases , no band forms in the test region, indicating a positive result.
Specifications
| Product Name | One step drug abuse test kit |
| Format | strip, cassette, uncut sheet, cup |
| Specimen | urine |
| Certificates | CE&ISO&510k |
| Sensitivity | high |
| Specificity | high |
| Real time | 5 minutes |
| Package | strip: 100pcs/box, cassette: 40pcs/box, cup- one with pouch, uncut sheet: 40pcs/bag |
| Shelf life | 24months |
| Limitatiom | for in-vitro diagnostic use only |
| Storage | room temperature(2-30°C), being kept away from direct sunlight, moisture and heat. |
| Note | DO NOT FREEZE |
The fresh urine samples should be collected in a clean , dry container such that same-day testing may be preformed . Urine specimens may be refrigerated at 2-8℃ for 48 hours, or frozen at -20℃ for assaying at a later date .Specimens that have been refrigarated or frozen must be equilibrated to room temperature before testing. Urine samples exhibiting visible precipitates should be filtered, centrifuged or allowed to settle so that clear aliquots can be obtained for testing.
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 open the pouch to avoid condensation of moisture on the membrane ). Label the device with patient or control number.
3. Immerse the strip into the sample with the arrow end pointing towards the sample. Take the cassette out after 10 seconds and lay the cassette flat on a clean, dry, nonabsorbent surface.
4. Read the tests result at five minutes.
Package Details
1. Each kit contain 100 or 40 test devices, each dealed in a foil pouch with three items inside:
a. One strip/ cassette/ cup device.
b. One plastic dropper
c. One deciccant
2. One package insert (instruction for use).
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