12 Panel CLIA Waived Multi Drug Dip Test – 25/Box (AMP / BAR / BUP / BZO / COC / mAMP / MDMA / MOP / MTD / OXY / PCP /THC)
$112.50
FDA 510(k) Cleared
25 tests per box
•
12-panel urine screening
One-step multi-drug urine dip card for the qualitative screening of 12 drugs and drug metabolites. Results are read at five minutes.
- Screens AMP, BAR, BUP, BZO, COC, mAMP, MDMA, MOP, MTD, OXY, PCP and THC
- Convenient one-step dip-card format
- Up to 99% total agreement with GC/MS for individual assays
- 25 individually packaged tests per box
Call for bulk pricing:
866-205-9215
| 1-5 | 6-10 | 11+ |
| $112.50 | $103.50 | $97.88 |
12-Panel Multi-Drug Dip Test Overview
The WDOA-6125 is a one-step lateral-flow immunoassay for the qualitative screening of 12 drugs and drug metabolites in human urine. The individual test strips are integrated into one convenient dip-card device, with results read at five minutes.
FDA 510(k) Cleared
12-Panel Screening
25 Tests per Box
Features and Benefits
CLIA-waived urine drug screening test
FDA 510(k) cleared configuration
Screens 12 drugs and drug metabolites
Results read at five minutes
One-step dip-card testing format
Up to 99% total agreement with GC/MS for individual assays
25 individually packaged tests per box
For professional in vitro diagnostic use
WDOA-6125
DTK-209120
This test provides only a preliminary qualitative result. A more specific confirmatory method should be used for any presumptive positive result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method described in the package insert.
Drugs and Cutoff Concentrations
The test screens for the following drugs and drug metabolites at the specified cutoff concentrations.
| Detectable Drug | Abbreviation | Cutoff | Estimated Detection Window |
|---|---|---|---|
| Amphetamine | AMP | 1,000 ng/mL | 2–3 days |
| Barbiturates | BAR | 300 ng/mL | 1–3 weeks |
| Benzodiazepines | BZO | 300 ng/mL | 1–4 days |
| Buprenorphine | BUP | 10 ng/mL | 1–3 days |
| Cocaine | COC | 300 ng/mL | 2–3 days |
| Ecstasy | MDMA | 500 ng/mL | 2–4 days |
| Marijuana | THC | 50 ng/mL | 1–7 days |
| Methadone | MTD | 300 ng/mL | 1–3 days |
| Methamphetamine | mAMP | 1,000 ng/mL | 2–3 days |
| Morphine | MOP | 300 ng/mL | 2–3 days |
| Oxycodone | OXY | 100 ng/mL | 1–2 days |
| Phencyclidine | PCP | 25 ng/mL | 7–14 days |
Detection windows are general estimates and can vary significantly based on frequency and duration of use, amount consumed, individual metabolism and other biological factors. Always follow the package insert when performing and interpreting the test.
How to Perform the Test
- Allow the test device and urine specimen to reach room temperature, between 10°C and 30°C.
- Open the sealed pouch and remove the test device.
- Remove the cap to expose the absorbent test strips.
- Immerse the absorbent strips in the urine specimen for approximately 10 seconds. Do not immerse the device above the marked maximum line.
- Remove the device, replace the cap and place the test on a clean, dry and nonabsorbent surface.
- Read the results at five minutes. Do not interpret the results after five minutes.
Understanding the Results
Negative: A control line and a test line appear. A faint test line is still interpreted as negative.
Preliminary positive: The control line appears, but no line appears in the applicable test region.
Invalid: The control line does not appear. Repeat the test using a new device.
Storage and Box Contents
Store sealed test devices between 4°C and 30°C
Keep away from direct sunlight, moisture and excessive heat
Do not freeze; use through the expiration date printed on the packaging
Includes 25 test devices and one package insert
Urine collection containers and a timer are required but are not included with the test devices.
Important Test Limitations
- This device is intended only for qualitative testing of human urine.
- The test does not determine drug concentration, intoxication or impairment.
- A negative result can occur when a drug is present below the test’s cutoff concentration.
- The test cannot distinguish between drug misuse and certain medications.
- Adulterants, bleach and other interfering substances may produce erroneous results.
- All preliminary positive results should be confirmed using a more specific analytical method.
Frequently Asked Questions
What drugs does this 12-panel test screen for?
It screens for amphetamine, barbiturates, buprenorphine, benzodiazepines, cocaine, methamphetamine, MDMA, morphine, methadone, oxycodone, phencyclidine and marijuana metabolites.
How quickly are results available?
Results should be read at five minutes. Results should not be interpreted after the five-minute reading period.
Is this drug test CLIA-waived?
Yes. This multi-drug urine test configuration is CLIA-waived and FDA 510(k) cleared.
How accurate is the test?
The package insert reports up to 99% total agreement with GC/MS for individual assays in this configuration. Performance varies by analyte, and the test must be stored, performed and interpreted according to the package insert.
Does a positive result confirm drug use?
No. A positive result is preliminary and should be confirmed using a more specific analytical method. GC/MS is the preferred confirmatory method described in the package insert.
How many tests are included?
Each box contains 25 individually packaged multi-drug dip-card tests.
Are urine collection cups included?
No. Urine collection containers and a timer are required but are not included.
What is the shelf life?
Use each test through the expiration date printed on its packaging. Store the sealed tests between 4°C and 30°C and do not freeze them.
Workplace Drug-Testing Resources
Drug-testing requirements vary by employer, industry and jurisdiction. Review applicable federal, state and local requirements before implementing a workplace testing program.
Additional information
| Weight | 1 lbs |
|---|---|
| Dimensions | 6 × 5 × 3 in |
