Common questions about rapid drug testing — answered by the team at American Screening Corp. Manufacturing CLIA-waived and FDA-cleared drug screening devices since 2004.
What is a CLIA-waived drug test?
A CLIA-waived drug test is a rapid diagnostic device that the FDA has determined is simple enough to be used outside of a certified laboratory. CLIA stands for Clinical Laboratory Improvement Amendments. CLIA-waived status means the test can be administered by trained non-laboratory personnel at the point of care — workplaces, clinics, treatment centers, schools — without requiring a CLIA-certified lab.
What is the difference between FDA-cleared and CLIA-waived?
FDA-cleared (specifically 510(k) cleared) means the test has been authorized by the FDA for marketing in the United States after demonstrating equivalence to a legally marketed predicate device. CLIA-waived is a separate classification that determines who can administer the test and under what conditions. Most workplace and point-of-care drug tests sold by ASC are both FDA 510(k) cleared AND CLIA-waived.
How accurate are rapid drug tests?
Rapid drug tests from American Screening Corp are typically 97-99% accurate when used according to instructions. Accuracy is measured against laboratory GC-MS (gas chromatography-mass spectrometry) confirmation. Rapid tests function as a screening tool — for legal or employment decisions, positive results should always be sent to a certified laboratory for confirmation using GC-MS or LC-MS/MS.
How long can urine drug tests detect substances?
Detection windows in urine vary by substance: amphetamines 1-3 days, cocaine 2-4 days, opiates 1-3 days, benzodiazepines 3-7 days (or 30+ days for chronic users), barbiturates 2-10 days, methadone 3-7 days, PCP 7-14 days, marijuana (THC) 3-30+ days depending on frequency of use.
How long can saliva drug tests detect substances?
Saliva (oral fluid) detection windows are typically shorter than urine: amphetamines 1-3 days, cocaine 1-2 days, opiates 1-3 days, marijuana 1-24 hours after use. Saliva is best suited for detecting recent use (last 24-48 hours), which makes it useful for post-accident and reasonable-suspicion testing.
What is a drug test panel?
A drug test panel refers to the number of substances the test screens for. A 5-panel test screens for amphetamines, cocaine, marijuana (THC), opiates, and PCP — the federally-mandated SAMHSA-5. Higher panels (10, 12, 14, 16-panel) add benzodiazepines, barbiturates, methadone, methamphetamine, MDMA, buprenorphine, oxycodone, fentanyl, tramadol, and other substances.
What is a cutoff level in drug testing?
A cutoff level is the minimum concentration of a substance (or its metabolite) in nanograms per milliliter (ng/mL) that produces a positive result. Results below the cutoff are reported as negative. Cutoffs are calibrated to balance sensitivity against specificity. ASC tests use SAMHSA-aligned cutoffs by default; custom cutoffs are available for specialized applications.
Are home drug tests as accurate as lab tests?
Rapid point-of-care drug tests have the same accuracy as the initial screening done by a laboratory — typically 97-99%. The difference is the confirmation step: a laboratory will reflex any positive screen to GC-MS or LC-MS/MS confirmation. For personal use, a positive rapid test is highly reliable; for employment or legal decisions, always confirm with a lab.
What drug testing is required for DOT compliance?
DOT-regulated employers (FMCSA, FAA, FRA, FTA, PHMSA, USCG) must follow 49 CFR Part 40 protocols: SAMHSA-5 panel urine drug tests, breath alcohol testing, certified collectors, HHS-certified lab analysis, and Medical Review Officer (MRO) verification. ASC carries DOT-compliant supplies and DOT Drug Test Software for program management.
Can I use ASC drug tests for pre-employment screening?
Yes — ASC drug tests are widely used for pre-employment screening across regulated and non-regulated industries. For non-DOT pre-employment screening, employers have flexibility in panel configuration and cutoff levels. For DOT pre-employment, 49 CFR Part 40 protocols apply. Document your testing policy in writing, apply it consistently, and use a Medical Review Officer to verify positives before adverse action.
How should employers handle a positive drug test result?
A positive rapid screening result should be treated as preliminary. Best practice: (1) explain the result to the employee privately, (2) send the sample to a SAMHSA-certified laboratory for GC-MS confirmation, (3) have an MRO verify the result and rule out legitimate medical explanations, (4) apply your written testing policy consistently. Adverse employment action should only be taken on MRO-verified positives.
How are drug tests shipped and stored?
American Screening Corp ships drug tests at standard ambient temperature via ground or expedited carriers. Most tests have 18-24 month shelf life from manufacture when stored between 36°F and 86°F. Refrigeration is not required. Tests should be kept in original packaging, away from moisture and direct sunlight, until use. Same-day shipping is available on in-stock orders.
Are American Screening Corp drug tests valid for court use?
Rapid screening tests are generally not admissible in court as standalone evidence — courts require GC-MS or LC-MS/MS laboratory confirmation. ASC supplies forensic-grade specimen collection cups with chain-of-custody documentation that meet legal-defensibility standards when paired with laboratory confirmation.
Can ASC customize drug tests for my industry?
Yes — ASC offers custom drug test cup configurations including custom panel combinations, branded packaging, cutoff calibrations for specialized applications, and private-label arrangements for distributors. Custom orders typically require 5,000+ unit minimum quantities and 30-60 day lead times.
What is bulk pricing for drug tests?
Bulk pricing tiers begin at 100-unit orders, with significant discounts at 500, 1,000, 5,000, and 10,000+ unit levels. For procurement teams managing testing programs at scale, request a bulk quote or call our pre-sales team at 318-798-3306. NET 30 terms are available for qualified business accounts.
Does ASC offer free samples?
Yes — qualified businesses, healthcare providers, and procurement teams can request a free sample kit for evaluation before placing a bulk order. Sample requests are reviewed by our pre-sales team; please provide your business name, intended use, and approximate annual volume to expedite the request.
Still have questions? Call 318-798-3306 (Monday-Friday 8am-5pm CT) or contact us. For bulk quotes, request a quote or request a sample.
