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Alere iScreen OFD cotinine oral fluid test device and cap

Alere iScreen OFD Cotinine Oral Fluid Screening

$159.95

Professional Use Only
Oral Fluid
30 ng/mL Cutoff
Read at 10 Minutes

Price per unit
•
$6.39

Instrument-free oral-fluid screening device for the qualitative detection of cotinine, the primary metabolite of nicotine, at a 30 ng/mL cutoff. The integrated collector and test provide a preliminary result that is read at 10 minutes.

  • Professional in vitro diagnostic use only
  • Collect oral fluid for at least 3 minutes
  • No separate screening instrument required
  • Integrated procedural control and supplied security seal
Professional-use test: This device provides a preliminary qualitative result. Follow the package insert and all applicable workplace-testing, confirmation and documentation requirements.
Quantity Discounts
1-5 6-10 11+
$159.95 $147.15 $139.16

Alere iScreen OFD Cotinine Test Overview

The Alere iScreen® OFD Cotinine Test Device is a professional-use, lateral-flow chromatographic immunoassay for the qualitative detection of cotinine in human oral fluid at a 30 ng/mL cutoff. The integrated device collects the oral-fluid specimen and produces a preliminary result without a separate screening instrument. Collect the specimen for at least 3 minutes and read the result at 10 minutes.

Professional Use Only
Oral Fluid
30 ng/mL Cutoff
Read at 10 Minutes
Professional in vitro diagnostic use only: This test is not labeled for over-the-counter home use. It provides only a preliminary analytical result, and professional judgment should be applied when interpreting results.

Features and Benefits

30 ng/mL cotinine cutoff
Qualitatively screens human oral fluid for cotinine, the primary metabolite of nicotine.

Integrated oral-fluid collection
The device includes a sponge collector for observed specimen collection.

Instrument-free screening
No separate screening machine is required to obtain the preliminary result.

Read at ten minutes
Interpret the result at 10 minutes and do not interpret it after 1 hour.

Built-in procedural control
A control line helps confirm sufficient specimen volume, membrane wicking and correct technique.

Laboratory-accessible reservoir
The capped device can be secured with the supplied seal and sent to a laboratory when confirmation is requested.

Reference
I-DCT-B702
SKU
DTK-106020
Specimen
Human oral fluid

Screening notice: A preliminary positive result is not a confirmed result and does not indicate the concentration of cotinine or the route of nicotine exposure. A negative result does not necessarily establish that the specimen is cotinine-free because cotinine may be present below the assay cutoff.

Test Specifications

Analyte Abbreviation Specimen Cutoff Collection Time Read Time
Cotinine COT Human oral fluid 30 ng/mL At least 3 minutes 10 minutes
Expected detection period: The product-specific package insert states that cotinine in saliva at the 30 ng/mL cutoff is expected to be detectable for up to 1-4 days after nicotine use. This is an expected period, not a guarantee for every donor; results depend on nicotine exposure, specimen concentration and individual factors.

How to Collect and Test the Specimen

Prepare the donor
The donor should not place food, drink, gum, candy, tobacco products or anything else in the mouth for at least 10 minutes before collection.

Bring the device to room temperature
Allow the sealed device to reach 15°C-30°C (59°F-86°F), then remove the test and cap from the pouch.

Collect oral fluid
Remove the sponge protector. Actively swab the inside of the mouth and top of the tongue, then gently press the softened sponge between the tongue and teeth.

Continue for at least three minutes
Collect until no hard spots remain in the sponge and a total of at least 3 minutes has elapsed.

Connect the collector and cap
Align the red arrow with a white mark, insert the collector vertically into the cap, press firmly and twist clockwise 180 degrees until the arrow reaches the second white mark.

Lay flat and read
Place the device horizontally on a clean, level surface with the result window facing up. Read the result at 10 minutes.

Required but not provided: A timer is required. Use only the collector supplied with the device and review the complete package insert and illustrated procedure card before testing.

Understanding the Results

Result Line Pattern Meaning
Negative One colored line appears in the control region (C), and a line appears in the cotinine test region (COT). Even a faint test line is interpreted as negative. The cotinine concentration is below the detectable cutoff. A negative result does not necessarily mean the specimen is cotinine-free.
Preliminary Positive One colored line appears in the control region (C), with no line in the cotinine test region (COT). The specimen produced a preliminary positive cotinine result. Follow applicable policy and confirmation requirements.
Invalid No control line appears, whether or not a cotinine test line is visible. The result is invalid. Repeat the test with a new device. If the problem persists, discontinue use of the lot and contact the manufacturer.
Confirmation: When a more specific result is required, the package insert identifies GC/MS, GC/MS/MS and LC/MS/MS as preferred confirmatory methods. Secure the cap with the supplied security seal before sending the device to a laboratory.

Performance Characteristics

Comparison Method Positive Agreement Negative Agreement Total Agreement
Commercial cotinine test 97.6% >99% 98.9%
LC/MS >99% 97.9% 98.6%
Performance context: These percentages are agreement results from the studies described in the package insert. They should not be converted into a blanket “99% accurate” claim.

Nicotine Exposure and Cotinine

Measures a nicotine metabolite
Cotinine is formed when the body metabolizes nicotine and generally remains detectable longer than nicotine itself.

Does not identify the nicotine source
A result cannot distinguish tobacco use from nicotine-replacement products or other sources of nicotine exposure.

Qualitative result only
The test does not measure the exact cotinine concentration or determine the route of exposure.

Policy review is essential
Employers should follow applicable laws, written testing policies and confirmation requirements before acting on results.

Storage and Handling

Store sealed at 2°C-30°C
Keep the device in its original sealed pouch at 36°F-86°F until use.

Use through the printed expiration
The insert states that the sealed device is stable through the expiration date printed on the pouch.

Do not freeze
Do not use a device that has been frozen or is beyond its expiration date.

Dispose appropriately
Discard used collectors and devices according to applicable federal, state and local requirements.

Instructions and Product Documents

Cotinine Test Package Insert
Illustrated Procedure Card
Manufacturer Product Brochure
Manufacturer Cotinine FAQ
Safety Data Sheet
Cotinine Test Training Sheet
Document note: The manufacturer brochure and general cotinine FAQ describe a 1-2 day detection period, while the product-specific package insert states an expected period of up to 1-4 days at the 30 ng/mL cutoff. Follow the package insert supplied with the product for product-specific instructions and limitations.

Frequently Asked Questions

What does the iScreen OFD cotinine test detect?

It qualitatively detects cotinine, the primary metabolite of nicotine, in human oral fluid at a 30 ng/mL cutoff.

Is this an over-the-counter home test?

No. The package insert labels this device for professional in vitro diagnostic use only.

Is the device CLIA-waived?

The product-specific materials reviewed for this configuration do not state that it is CLIA-waived. Do not represent it as CLIA-waived without current product-specific documentation.

How long does oral-fluid collection take?

Actively collect oral fluid for at least 3 minutes and continue until the collection sponge has softened completely with no hard spots.

Can the donor eat, drink or use tobacco immediately before testing?

No. The donor should place nothing in the mouth, including food, drink, gum, candy or tobacco products, for at least 10 minutes before collection.

When should the result be read?

Read the result at 10 minutes. The package insert states that the result should not be read after 1 hour.

How long can cotinine remain detectable in oral fluid?

The package insert states that cotinine at the 30 ng/mL cutoff is expected to be detectable for up to 1-4 days after nicotine use. The actual period varies by exposure and individual factors.

Can nicotine patches or gum produce a positive result?

Yes. Cotinine is produced when nicotine is metabolized, regardless of whether the nicotine came from tobacco or nicotine-replacement therapy. The test does not identify the source of exposure.

Is a preliminary positive result final?

No. Follow applicable policy and confirmation requirements. The insert identifies GC/MS, GC/MS/MS and LC/MS/MS as preferred confirmation methods.

Does a negative result prove that no cotinine is present?

No. Cotinine may be present below the assay cutoff, so a negative result does not necessarily establish a cotinine-free specimen.

Looking for current tobacco and nicotine information?

Review CDC Smoking and Tobacco Information

Additional information

Weight 6 lbs
Dimensions 15 × 15 × 4.5 in

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