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Accutest BUP buprenorphine urine drug test dip card with cap
drug test, buprenorphine dip test
drug test, buprenorphine dip test

Accutest Buprenorphine Drug Screen Dip Test Card – 25/Box (BUP)

$37.50

FDA 510(k) Cleared
Prescription Use
CLIA Non-Waived

25 tests per box$1.50 per test

Professional single-panel urine dip card for preliminary qualitative screening of buprenorphine (BUP) at a 10 ng/mL cutoff. Read results at 5 minutes.

  • Buprenorphine screening at a 10 ng/mL cutoff
  • 99% overall agreement reported in the package-insert study
  • Simple, single-use dip-card format
  • Store sealed at 2–30°C and verify the printed expiration date
Quantity Discounts
1-5 6-10 11+
$37.50 $34.50 $32.63

Accutest Buprenorphine Drug Test Overview

The Accutest Buprenorphine Drug Test is a single-use urine dip card for preliminary qualitative screening of buprenorphine (BUP) at a 10 ng/mL cutoff. It is intended for healthcare-professional use, including point-of-care settings, and may assist with monitoring drug compliance. Read the result at 5 minutes. Each box contains 25 tests.

FDA 510(k) Cleared
Prescription Use
CLIA Non-Waived
25 Tests per Box

Features and Benefits

Single-panel BUP screeningScreens human urine for buprenorphine at a 10 ng/mL cutoff.

Results at 5 minutesUse a timer and interpret the result at the time specified in the package insert.

One-step dip-card formatNo separate reagents are required to perform the test.

Built-in procedural controlThe control line confirms sufficient specimen volume and proper membrane flow.

99% overall agreementThe package-insert performance study reports 99% overall agreement with LC/MS.

Room-temperature storageStore the sealed test at 2–30°C (36–86°F) and verify the printed expiration date before use.

Product Details

Reference
DS220AC225
SKU
DTK-109012
Sample
Human Urine
Package
25 Tests per Box

Specification Details
Brand Accutest
FDA clearance holder ACON Laboratories, Inc.
Test format Single-panel urine dip card
Test method Competitive lateral-flow chromatographic immunoassay
Result type Preliminary qualitative screening result
Analyte Buprenorphine
Cutoff 10 ng/mL
Read time 5 minutes
Intended use Prescription use by healthcare professionals, including point-of-care settings
Regulatory status FDA 510(k) cleared under K060466; CLIA non-waived
Storage 2–30°C (36–86°F); do not freeze

Buprenorphine Test and Cutoff

Detectable Drug Abbreviation Cutoff
Buprenorphine BUP 10 ng/mL

Drug-detection periods vary with the dose, frequency and timing of use, specimen collection, individual metabolism and other biological factors. A screening result does not determine impairment. Follow the package insert supplied with the current lot when performing and interpreting the test.

How to Perform the Test

Prepare the testAllow the sealed test, urine specimen and any controls to reach 15–30°C (59–86°F) before testing.

Dip the cardRemove the cap and immerse the test strips vertically in the urine for at least 10–15 seconds, up to the wavy lines but not above the arrows.

Replace the capRemove the card from the specimen, replace the cap and place the device on a clean, flat, non-absorbent surface.

Read at 5 minutesUse a timer and interpret the result at 5 minutes. The package insert states that results remain stable for up to one hour.

Understanding the Results

NegativeTwo lines appear: one control line at C and one test line at T. Any visible test line is interpreted as negative, even when faint.

Preliminary positiveThe control line appears at C, but no test line appears at T. Confirm the result with a more specific laboratory method.

InvalidNo control line appears. Repeat the test with a new device and follow the package insert carefully.

Professional-use notice: This device is not labeled for over-the-counter use and is not CLIA waived. It provides only a preliminary qualitative result. Confirm a preliminary positive result with a more specific alternative method such as GC/MS or LC/MS, and apply professional judgment to every result.

Storage and Expiration

Store the unopened test in its sealed pouch at 2–30°C (36–86°F). Do not freeze, keep the test sealed until use and do not use it after the expiration date printed on the pouch. The package insert supports stability through the printed expiration date but does not state a fixed 24-month shelf life.

Instructions and Regulatory Documents

Buprenorphine Test Package Insert
FDA 510(k) K060466

Frequently Asked Questions

What does this drug test screen for?

This single-panel test screens human urine for buprenorphine at a 10 ng/mL cutoff.

How quickly are results available?

Read the result at 5 minutes. Follow the package insert supplied with the current lot for the complete testing procedure and permitted interpretation window.

Is this buprenorphine test CLIA waived?

No. This configuration is CLIA non-waived and is categorized as moderate complexity.

Is this test intended for over-the-counter use?

No. FDA documentation identifies this test for prescription use by healthcare professionals, including point-of-care settings.

What does a faint test line mean?

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

Does a preliminary positive result require confirmation?

Yes. A preliminary positive screening result must be confirmed with a more specific laboratory method such as GC/MS or LC/MS.

How should the tests be stored?

Store the sealed tests at 2–30°C (36–86°F), do not freeze and verify the expiration date on each pouch before use.

How many tests are included?

Each box contains 25 single-use Accutest buprenorphine urine drug test dip cards.

What does the 99% performance statement mean?

The package-insert study reports 99% overall agreement with LC/MS. Performance can vary near the cutoff and depends on correct storage, specimen collection, testing and interpretation. The result remains preliminary.

Workplace Drug-Testing Resources

Testing requirements vary by employer, industry and jurisdiction. Review applicable federal, state and local requirements before implementing a workplace testing program.

Review SAMHSA Workplace Resources

Additional information

Weight 1 lbs
Dimensions 6 × 5 × 3 in

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