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ACCUTEST saliva cotinine test device and oral-fluid collector
Accutest Saliva Cotinine Test
Accutest Saliva Cotinine Test

Accutest Saliva Cotinine Test (25/Box)

$98.75

OTC Use
CLIA Waived
30 ng/mL Cutoff

25 tests per box$3.95 per test

A rapid oral-fluid cotinine test for qualitative screening at a 30 ng/mL cutoff. The integrated collection swab includes a specimen-saturation indicator, and results are read at 10 minutes.

  • Detects cotinine (COT), a primary nicotine metabolite, in human oral fluid
  • Over-the-counter use and CLIA-waived testing configuration
  • Integrated oral-fluid collector with a visible saturation indicator
  • No analyzer required; 25 individually packaged tests per box

ACCUTEST Saliva Cotinine Test Overview

The ACCUTEST Saliva Cotinine Test, reference DS443, is a single-use lateral-flow test for the qualitative detection of cotinine in human oral fluid at a 30 ng/mL cutoff. Cotinine is a primary metabolite of nicotine. The integrated collector uses a color indicator to help confirm that oral-fluid collection is complete, and the visually interpreted result is read at 10 minutes. Each box contains 25 tests.

OTC Use
CLIA Waived
COT 30 ng/mL
25 Tests per Box

Features and Benefits

Oral-fluid cotinine screeningQualitatively detects cotinine, a primary nicotine metabolite, in human oral fluid at a 30 ng/mL cutoff.

Results at 10 minutesThe integrated test is visually interpreted without an analyzer or other instrument.

Saturation indicatorThe collector’s indicator changes color when sufficient oral fluid has been collected.

Integrated collection systemThe provided collector screws directly into the test device, reducing specimen-transfer steps.

Built-in procedural controlA colored control line helps verify sufficient specimen volume, adequate membrane wicking and correct procedure.

OTC and CLIA waivedThe current device configuration is identified for over-the-counter use and categorized as CLIA waived.

Product Details

Reference
DS443
SKU
DTK-109143
Sample
Oral Fluid
Package
25 Tests per Box

Specification Details
Brand ACCUTEST
Manufactured for Jant Pharmacal Corporation
Catalog reference DS443
Test format Single-use integrated oral-fluid test mini cube with collection swab
Test method Competitive-binding lateral-flow chromatographic immunoassay
Analyte Cotinine (COT), a primary nicotine metabolite
Sample Human oral fluid
Cutoff 30 ng/mL
Pre-collection wait Nothing in the mouth for at least 10 minutes before collection
Collection indicator Visible color change confirms collection; if the indicator does not change color after 7 minutes, discard the device and repeat the test
Result type Preliminary qualitative screening result
Read time 10 minutes
Regulatory status Over-the-counter use; CLIA waived
Instrument requirement None
Package size 25 tests per box

This test detects cotinine and does not identify the nicotine source, the amount used or the exact time of exposure. Nicotine from cigarettes, vaping products, smokeless tobacco, nicotine pouches and nicotine-replacement products may produce cotinine.

How to Perform the Test

Wait before collectionDo not place food, drink, gum, tobacco products or anything else in the mouth for at least 10 minutes before collecting oral fluid.

Prepare the testBring the sealed test to room temperature, open the pouch and place the test device on a clean, flat surface.

Collect oral fluidSweep the collector along the cheek, gums and tongue several times, then hold it in the mouth. Do not bite, suck or chew the sponge.

Watch the indicatorRemove the collector when color appears in the indicator window. If the saturation indicator does not change color after 7 minutes, discard the device and repeat the test with a new device.

Insert the collectorKeep the device upright and screw the sponge end gently into the test device until the collector cap is sealed tightly.

Read the resultKeep the device upright on the flat surface and interpret the colored lines at 10 minutes.

ACCUTEST saliva cotinine test oral-fluid collection procedure
Collect oral fluid until the saturation indicator changes color, then screw the collector into the upright test device.

Understanding the Test Results

Preliminary positiveA colored control line appears at C, but no line appears at T. The cotinine concentration is at or above the test cutoff.

NegativeColored lines appear at both C and T. Any visible test line, even a faint line, is interpreted as negative.

InvalidNo control line appears at C. Review the procedure and repeat the test with a new device.

ACCUTEST saliva cotinine test preliminary positive, negative and invalid results
Result guide for preliminary positive, negative and invalid ACCUTEST saliva cotinine test results.
Preliminary-result notice: This screening test provides a preliminary qualitative result. A more specific laboratory method should be used when confirmation is required. Clinical or professional judgment should be applied when evaluating a preliminary positive result.

What Is Included?

Test devicesTwenty-five individually packaged, single-use oral-fluid cotinine test devices.

Oral-fluid collectorsCollection swabs with specimen-saturation indicators are supplied for use with the test devices.

Instructions for useCurrent DS443 over-the-counter instructions are supplied. A timer or clock and disposable gloves are required but not provided.

Storage and Handling

Keep sealed until useLeave each test device in its sealed pouch until immediately before testing.

Store at 4–30°CStore the sealed tests at 4–30°C (39–86°F), refrigerated or at room temperature.

Do not freezeKeep the tests away from direct sunlight, moisture and heat.

Check expirationDo not use a test after the expiration date printed on its sealed pouch.

Product and Regulatory Documents

DS443 Instructions for Use (IFU)
ACCUTEST Saliva Cotinine Test Brochure
FDA 510(k) K223162

Frequently Asked Questions

What does the ACCUTEST Saliva Cotinine Test detect?

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

What is the cotinine cutoff?

The cutoff is 30 ng/mL in human oral fluid.

How quickly are results available?

Interpret the result at 10 minutes after the collection swab has been secured in the test device.

What does a faint test line mean?

When the control line is present, any visible line at T is interpreted as negative, even if the test line is faint.

Is the ACCUTEST Saliva Cotinine Test OTC and CLIA waived?

Yes. The current DS443 instructions for use and product brochure identify the test for over-the-counter use and as CLIA waived.

Can the test distinguish smoking from vaping or nicotine-replacement products?

No. The test detects cotinine and does not identify the nicotine source. Nicotine exposure from cigarettes, vaping products, smokeless tobacco, nicotine pouches or nicotine-replacement products may produce cotinine.

How long can cotinine remain detectable in oral fluid?

The older technical insert describes an expected detection window of up to approximately 1–4 days at the 30 ng/mL cutoff. Actual detection varies with the source and amount of nicotine exposure, frequency of use, specimen timing and individual metabolism.

Does a preliminary positive result require confirmation?

Use a more specific laboratory method when confirmation is required. A preliminary positive screening result should be evaluated together with other available information.

How many tests are included?

Each box contains 25 single-use oral-fluid cotinine test devices with collection swabs and instructions for use.

Review the Collection and Result Guide

The product brochure includes the three-step collection sequence and the preliminary positive, negative and invalid result illustrations preserved on this page.

View the Product Brochure

Additional information

Weight 6 lbs
Dimensions 15 × 15 × 4.5 in

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