Accutest H. Pylori – Whole Blood/Serum (20 Tests/Kit)
$82.60
Serum: Moderate Complexity
3–7 Minute Results
20 Tests/Kit
20 tests per kit • $4.13 per test
The Accutest® H. pylori Whole Blood/Serum Test is a rapid lateral flow, qualitative immunoassay for detecting IgG antibodies specific to Helicobacter pylori in human whole blood or serum. Intended for professional point-of-care use as an aid in diagnosis, it provides results in 3–7 minutes.
- CLIA-waived when used with whole blood
- Moderate complexity when used with serum
- Strong positive results may appear in 2–3 minutes; read all results by 7 minutes
- 20 individually pouched test cassettes per kit
- Positive and negative controls included and packed separately
| 1-5 | 6-10 | 11+ |
| $82.60 | $75.99 | $71.86 |
Accutest H. pylori Whole Blood/Serum Test Overview
The Accutest® H. pylori Whole Blood/Serum Test is a rapid, double-antigen lateral flow immunoassay for the qualitative detection of IgG antibodies specific to Helicobacter pylori in human whole blood or serum. It is intended for professional use at point-of-care facilities as an aid in the diagnosis of H. pylori infection.
The cassette provides rapid visual results using one drop of whole blood or serum followed by three drops of wash buffer. Strong positive results may appear within 2–3 minutes, while weak positive results may require up to 7 minutes.
Professional Use
IgG Antibody Test
20 Tests per Kit
Features and Benefits
Qualitatively detects IgG antibodies specific to H. pylori
Accepts human whole-blood or serum specimens
Provides visual results in 3–7 minutes
CLIA-waived for whole blood; serum testing is moderate complexity
Positive and negative external controls are included and packed separately
Room-temperature storage within the labeled range of 59–86°F (15–30°C)
Product Details
ID392
DTK-101507
20 Tests per Kit
K024350
Technical Specifications
| Specification | Details |
|---|---|
| Test method | Double-antigen chromatographic lateral flow immunoassay |
| Detected marker | IgG antibodies specific to Helicobacter pylori |
| Specimen types | Human whole blood or serum |
| Format | Visual-read cassette |
| Result time | Strong positives may appear in 2–3 minutes; weak positives may take up to 7 minutes; do not interpret after 7 minutes |
| CLIA complexity | Waived for whole blood; moderate complexity for serum |
| Intended use | Professional point-of-care use as an aid in the diagnosis of H. pylori infection |
| Evaluated population | The assay has not been established for patients younger than 19 years |
| Storage | 59–86°F (15–30°C); do not freeze or expose above 86°F (30°C) |
| Labeled stability | Two years or until the expiration date printed on the label, whichever comes first |
| Package size | 20 tests per kit; positive and negative controls included and packed separately |
Manufacturer-Listed CPT Codes
| Specimen | Manufacturer-Listed Code |
|---|---|
| Whole blood | 86318QW |
| Serum | 86677 |
Coding and reimbursement requirements vary by payer, setting and current policy. Confirm the appropriate code before billing.
Kit Contents
20 individually pouched test devices
One disposable dropper pipette in each device pouch
One 7 mL bottle of wash buffer
Positive and negative controls, 1 mL each, packed separately
Package insert with instructions for use
A lancet or other blood-collection device and a timer are required but are not provided with the test kit.
Test Procedure Summary
Prepare: Bring refrigerated specimens and test materials to room temperature. Open the cassette pouch immediately before testing and label the device.
Add specimen: Add one drop of fresh whole blood or serum to the sample well marked S and allow approximately 30 seconds for absorption.
Add buffer: Discard the first three drops from the wash-buffer bottle, then add three drops of wash buffer to the sample well.
Read: Strong positive results may appear within 2–3 minutes. Allow up to 7 minutes for weak positive results and do not interpret after 7 minutes.
This summary does not replace the package insert. Follow the current instructions supplied with the kit for specimen collection, quality control, testing, interpretation, precautions and disposal.
Understanding the Results
Positive: Both the Control line and Test line appear, indicating that IgG antibodies specific to H. pylori were detected.
Negative: Only the Control line appears, indicating that antibodies to H. pylori were not detected at the test’s detectable level.
Invalid: If no Control line appears within 5 minutes, repeat the assay with a new test device.
A faint Test line is considered a borderline result and should be retested using an alternative method for confirmation, as directed in the package insert.
Clinical Performance
The manufacturer evaluated 296 confirmed clinical serum specimens, including 144 positive and 152 negative specimens. The package insert reports the following performance against the clinical confirmed results.
| Performance Measure | Reported Result |
|---|---|
| Sensitivity | 95.1% (137/144) |
| Specificity | 94.1% (143/152) |
In a separate side-by-side comparison with a legally marketed device using 296 serum specimens, the insert reports 97.9% positive agreement and 97.4% negative agreement.
Performance values describe the manufacturer’s reported studies and do not guarantee that every individual result will be correct. Proper specimen collection and strict adherence to the package insert are required.
Storage and Handling
Store the kit at 59–86°F (15–30°C)
Do not freeze or expose the kit above 86°F (30°C)
Keep test devices sealed until immediately before use
Do not use the kit after the expiration date printed on the label
Under the labeled storage conditions, the package insert states that the kit contents are stable for two years or until the printed expiration date, whichever comes first.
Instructions and Product Documents
Frequently Asked Questions
What does the Accutest H. pylori test detect?
It qualitatively detects IgG antibodies specific to Helicobacter pylori in human whole blood or serum as an aid in diagnosis.
Is the Accutest H. pylori test CLIA-waived?
It is CLIA-waived when used with whole blood. Serum testing is moderate complexity and must be performed under the appropriate laboratory certification.
Is this an over-the-counter home test?
No. This is a professional in-vitro diagnostic test intended for point-of-care facilities.
How quickly are results available?
Strong positive results may appear within 2–3 minutes, while weak positive results may require up to 7 minutes. Do not interpret the cassette after 7 minutes.
Does a positive antibody result prove an active H. pylori infection?
No. The package insert states that a positive result does not distinguish active infection from colonization. Results must be evaluated with clinical information and other confirmatory methods available to the physician.
Are controls included?
Yes. The manufacturer lists one 1 mL positive control and one 1 mL negative control as included with ID392 and packed separately.
Can this test be used for patients younger than 19?
The package insert states that the assay has not been established for patients younger than 19 years.
How many tests are included?
This configuration contains 20 individually pouched test devices, each with a disposable dropper pipette, plus wash buffer and the listed controls.
Need Manufacturer Product Information?
Visit the official Jant Pharmacal product page for current product information, documentation and support.
Additional information
| Weight | 1 lbs |
|---|---|
| Dimensions | 2 × 6 × 2 in |
