Negative Cotinine Test is a colloidal gold-based immunochromatographic assay purpose-built for the qualitative confirmation of nicotine abstinence through the detection of Cotinine-the primary metabolite of nicotine-in human urine. Unlike general-purpose drug tests that simply flag "positive" or "negative," our product is optimized to deliver exceptional negative predictive value (NPV) , providing insurers, employers, and healthcare providers with the highest confidence in identifying individuals who have successfully quit or never used tobacco products.
Superior Product Features:
· Ultra-Low False-Positive Design – Engineered specifically to minimize false-negative results (which, in this application, would incorrectly label a smoker as "negative"). Our stringent quality control ensures that only true non-smokers receive a negative readout.
· Room-Temperature Storage (2–30°C) – 24-month shelf life with no cold chain required, drastically reducing warehousing costs and simplifying distribution to remote and temperature-variable regions.
· Rapid Readout (5–10 minutes) – Provides immediate, actionable results during patient visits, insurance exams, or on-site wellness events, eliminating follow-up appointments and logistical delays.
· One-Step Simple Operation – No instrumentation, no sample preparation beyond urine collection. Results are visually interpreted by non-laboratory personnel after a simple dip-or-drop procedure.
OEM & Distribution Partnership – We offer full private-labeling services including custom-branded cassettes/strips, bespoke packaging designs, tailored IFU documentation, and co-branded marketing materials. With a standard MOQ of 500 units and flexible trial-order options for new partners, we facilitate low-risk market entry. Bulk pricing, dedicated technical account management, and supply chain continuity are guaranteed for established distribution agreements.
Choose our Negative Cotinine Test for definitive, documentable proof of nicotine-free status-empowering insurers, employers, and clinicians to make objective, fair, and evidence-based decisions with complete confidence.
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Product name |
COT Rapid Test |
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Item type |
COT-U11, COT-U21 |
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Specimens |
Urine |
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Packing Specification |
50 strips/box, 25 cassettes/box |
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Shelf life |
2 years |
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Test Time |
Waiting about 5 minutes |
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Certificate |
CE, ISO:13485 |
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OEM |
Acceptable |
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Storage condition |
The kit should be stored at 2-30°C |
STORAGE AND STABILITY
- The kit should be stored at 2-30°C until the expiry date printed on the sealed pouch.
- The test must remain in the sealed pouch until use.
- Do not freeze.
- Cares should be taken to protect components in this kit from contamination.
SPECIMEN COLLECTION AND STORAGE
- The urine specimen must be collected in a clean and dry container. Urine collected at any time of the day may be used. Urine specimens exhibiting visible particles should be centrifuged, filtered, or allowed to settle to obtain clear specimen for testing.
- Collected urine specimens must be put in clear and dry containers.
- Perform the testing immediately after the specimen collection. Do not leave the specimens at room temperature for prolonged periods. Specimens may be stored at 2-8°C for up to 48 hours. For long term storage, specimens should be kept below -20°C.
- Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed and mixed well prior to testing. Avoid repeated freezing and thawing of specimens.
- Pack the specimens in compliance with applicable regulations for transportation of etiological agents, in case they need to be shipped.
FAQ
Q: What does a "negative" result on this test actually mean? How reliable is it?
A: A negative result at the 200 ng/mL cut-off indicates that the individual's urinary Cotinine concentration is below the internationally accepted threshold for active smoking-meaning they are either a non-smoker, a former smoker who has abstained for 2–4 days, or someone with only passive environmental exposure. Our test achieves ≥99.5% specificity and a negligible false-negative rate, making it one of the most reliable tools for objective nicotine-free certification in insurance, employment, and clinical settings. We provide batch-specific validation data with every shipment.
Q: Can this test distinguish between someone who has quit smoking versus someone who never smoked?
A: Yes. Both non-smokers and successful quitters (with ≥2–4 days of abstinence) will produce a negative result at the 200 ng/mL cut-off, as their Cotinine levels drop below this threshold. For programs requiring finer differentiation-such as distinguishing passive from active exposure-we offer customizable lower cut-offs (e.g., 50 ng/mL or 100 ng/mL) to capture even trace levels of nicotine metabolites. Please specify your exact requirements for a tailored solution.
Q: What documentation do you provide to support the use of this test for insurance or legal purposes?
A: We provide comprehensive documentation including batch-specific Certificates of Analysis (COA) , stability validation reports, detailed IFU (Instruction For Use), CE/FDA/ISO13485 certificates, and cross-reactivity study data. For insurance underwriters and corporate clients requiring auditable records, we can also supply lot-to-lot consistency data and quality control protocols to support your internal validation and regulatory compliance processes.
Q: How long after quitting smoking will a person test "negative" on your Cotinine test?
A: Cotinine has a biological half-life of approximately 16–20 hours. Following complete smoking cessation, urinary Cotinine levels typically fall below the 200 ng/mL cut-off within 2 to 4 days, depending on individual metabolism, the intensity of prior use, and hydration levels. This makes our test suitable for monitoring short-term compliance in smoking cessation programs and for verifying self-reported abstinence during insurance medical exams.
Q:Can this Negative Cotinine Test be combined with other drug panels in a single device?
A: Absolutely. While offered as a standalone single-parameter test for dedicated Cotinine screening, we provide flexible multiplex integration-combining Cotinine with other DOA markers in a single strip or cassette. This is particularly valuable for comprehensive wellness screening and pre-employment panels where both tobacco-use status and substance abuse history need to be assessed simultaneously. Please specify your desired panel configuration for a customized quotation.
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