Accutest H. pylori Urease Test CLIA Waived (50 Tests/Kit)
$347.00
Gastric Biopsy
Positive Results in as Little as 1 Minute
50 Tests/Kit
50 tests per kit
•
$6.94 per test
CLIA-waived rapid urease test for the qualitative detection of urease in gastric mucosal biopsy specimens for the presumptive determination of Helicobacter pylori in symptomatic adult patients. Positive results may appear in as little as one minute; confirm a negative result at one hour.
- Dry test with no added test reagents or incubation equipment
- Read at 5, 30 and 60 minutes
- Room-temperature storage; no refrigeration required
- Includes 50 test slides and a positive liquid control
| 1-5 | 6-10 | 11+ |
| $347.00 | $330.00 | $320.00 |
Accutest H. pylori Rapid Urease Test Overview
The Accutest® H. pylori Rapid Urease Test is a CLIA-waived, qualitative test for detecting the urease enzyme in gastric mucosal biopsy specimens. It is intended for the presumptive determination of Helicobacter pylori in symptomatic adult patients. Positive results may develop in as little as one minute, while a negative result is confirmed when the reactive pad remains yellow at one hour.
The dry test requires no added test reagents, refrigeration or incubation equipment. Each kit contains 50 single-use test slides, instructions for use and a positive liquid control.
Gastric Biopsy
Rapid Urease Test
50 Tests/Kit
Features and Benefits
For use by facilities operating under a CLIA Certificate of Waiver when the manufacturer’s instructions are followed without modification.
Positive reactions may appear in as little as one minute. Examine the test at 5, 30 and 60 minutes and confirm a negative result at one hour.
Qualitatively detects urease in gastric mucosal biopsy tissue from symptomatic adult patients.
No added test reagents or incubation equipment are required for patient testing.
No refrigeration is required. Store away from direct light and observe the expiration date printed on the packaging.
The current 50-test kit includes a positive liquid control for the required new-kit quality-control check.
ID750
DTK-101750
50 tests with positive control
Kit Contents
| Included | Not Included |
|---|---|
| 50 Accutest rapid urease test slides | Biopsy forceps for specimen collection |
| Instructions for use | Sterile blunt instrument for specimen transfer |
| Positive liquid control | Other supplies required by the facility’s endoscopy and biosafety procedures |
Basic Test Procedure
Before use, confirm that the reactive test surface is yellow. Do not use a slide if the test surface is already red or magenta.
Peel back the label to expose the yellow reactive pad.
Using a sterile blunt instrument, transfer the gastric mucosal biopsy specimen from the forceps to the yellow pad and position the tissue for maximum contact.
Reseal the slide, press the label lightly over the reactive pad and record the patient’s name, date and specimen-insertion time. Proper resealing helps prevent the specimen from drying.
Examine the test at 5 minutes, 30 minutes and one hour. A positive reaction may appear earlier, but a negative result is not final until one hour.
Result Interpretation
| Result | Reactive-Pad Appearance | Interpretation |
|---|---|---|
| Positive | An expanding red zone appears around the biopsy, or the pad changes from deep orange to red at any time within one hour. | Presumptive positive for H. pylori-associated urease in the gastric biopsy specimen. |
| Negative | The reactive pad remains yellow one hour after the specimen is inserted. | No urease reaction was detected under the test conditions. Consider the limitations in the package insert. |
| Do Not Use | The unused test surface is red or magenta before the specimen is applied. | Do not use that slide. Select a test with a yellow reactive surface. |
Performance Information
The current Revision D package insert reports the following study results. Performance values should be read in the context of the study design, comparator and confidence intervals described in the complete insert.
| Study | Positive Performance | Negative Performance |
|---|---|---|
| 2006 clinical comparison with histology; 100 specimens | 100% sensitivity; 95% CI 97.5%–100% | 100% specificity; 95% CI 97.5%–100% |
| CLIA-waiver study; clinical biopsy specimens | 91.2% positive agreement versus histology | 98.7% negative agreement versus histology |
| CLIA-waiver study; contrived specimens | 97.2% positive agreement versus expected results | 95.5% negative agreement versus expected results |
Storage and Quality Control
The current Revision D insert lists a 36-month shelf life. Always verify the expiration date printed on the product packaging.
Store the test slides at room temperature away from direct light. No refrigeration is required.
Perform one positive external control when opening a new 50-test kit, following the current test and control instructions.
Instructions and Product Documents
Accutest ID750 Quick Reference Instructions
Accutest ID750 Package Insert – Revision D
Accutest IDC73 Positive Control Instructions
Frequently Asked Questions
Is the Accutest H. pylori Urease Test CLIA-waived?
Yes. The current package insert identifies the test as CLIA-waived. Testing facilities must hold a CLIA Certificate of Waiver and follow the manufacturer’s instructions without modification.
What specimen does the test use?
The waived specimen type is a gastric mucosal biopsy specimen collected during endoscopy from a symptomatic adult patient.
What does the test detect?
It qualitatively detects the urease enzyme in gastric mucosal biopsy tissue for the presumptive determination of Helicobacter pylori.
How quickly are results available?
A positive reaction may develop in as little as one minute. Examine the test at 5, 30 and 60 minutes. A negative result is confirmed when the reactive pad remains yellow at one hour.
Is a positive result considered a final diagnosis?
No. The test provides a presumptive qualitative result. Interpret it with the patient’s clinical findings and consider additional diagnostic methods when indicated.
Are additional reagents or an incubator required?
No additional patient-test reagents or incubation equipment are required. Biopsy forceps and a sterile blunt specimen-transfer instrument are not included.
Is a positive control included?
Yes. The current Revision D insert states that the 50-test kit includes a positive liquid control. Perform one positive external control when opening a new kit.
How should the test kit be stored?
Store the test slides at room temperature away from direct light. The current Revision D insert lists a 36-month shelf life; always follow the expiration date printed on the packaging.
What billing code is associated with this waived test?
CMS materials list the Jant Accutest Rapid Urease Test under CPT code 87077 with the QW modifier for waived testing. Coding, coverage and reimbursement requirements can change, so verify the current code and payer requirements before billing.
How many tests are included?
Each kit contains 50 single-use rapid urease test slides, instructions for use and a positive liquid control.
Learn more about H. pylori
Review the National Cancer Institute’s information about H. pylori infection, gastric disease and cancer risk.
Additional information
| Weight | 2 lbs |
|---|---|
| Dimensions | 12 × 8 × 6 in |
