ProDetect™ H.Pylori Antigen Rapid Test
Catalog Number:
- PD242001(1Prep)
- PD242002(20Preps)
Package Specification: 1,20 tests/kit
Description
Details
Resources
COA
Description
Helicobacter pylori (H. Pylori) is a small, spiral-shaped bacterium that lives in the surface of the stomach and duodenum. It is implicated in the etiology of a variety of gastrointestinal diseases, including duodenal and gastric ulcer, non-ulcer dyspepsia and active and chronic gastritis. Both invasive and non-invasive methods are used to diagnose H. Pylori infection in patients with symptoms of gastrointestinal disease. Specimen dependent and costly invasive diagnostic methods include gastric or duodenal biopsy followed by urease testing (presumptive), culture, and/or histologic staining. A very common approach to the diagnosis of H. Pylori infection is the serological identification of specific antibodies in infection patients. The main limitation of serology test is the inability to distinguish current and past infections. Antibody may be present in the patient’s serum long after eradication of the organisms. HpSA (H. Pylori stool antigen) testing is gaining popularity for diagnosis of H. Pylori infection and also for monitoring the efficacy of the treatment of H. Pylori infection. Studies have found that more than 90% of patients with duodenal ulcer and 80% of patients with gastric ulcer are infected with H. pylori. ProDetect™ H. Pylori Antigen Rapid Test utilizes specific antibodies to qualitatively detect H. Pylori antigens in human fecal specimens. The test can be performed without cumbersome laboratory equipment, and the results are available within 20 minutes.
Details
Principle
ProDetect™ H. Pylori Antigen Rapid Test is a qualitative membrane-based immunoassay for the detection of H. Pylori antigens in human fecal specimens. The membrane is pre-coated with specific anti-H. Pylori antibodies in the test line region. During testing, the specimen reacts with the particle coated with anti-H. Pylori antibodies to form an antigen-antibody-gold complex. The mixture migrates upward on the membrane chromatographically by capillary action to react with anti-H. Pylori antibodies immobilized in the membrane and produce a colored line. The presence of this colored line in the test line region (T), indicates a positive result, while its absence indicates a negative result. An internal quality control is included in the test, in the form of a colored line appearing in the control line region (C), indicating that the test is functional, and proper and sufficient volume of specimen has been applied to enable migration through the test and control line, regardless of whether there is a test line or not. If the control line (C) does not appear within the testing time, test result is invalid, and the test should be repeated with a new test device.Sample Collection and Preparation
Consider any materials of human origin as infectious and handle them using standard biosafety procedures. Follow standard laboratory procedures to collect specimens.- Collect a random sample of feces in a clean, dry specimen collection container.
- Label the specimen collection tube with the specimen’s ID number. Unscrew the top of the specimen collection tube and then randomly stab the specimen collection stick into the fecal specimen in at least five different sites. Do not scoop the fecal specimen. Ensure that stool specimen is only in the grooves of the collection stick. Excess stool specimen may result in an invalid test result.
- Screw on the collection stick in the tube and tighten securely to close the specimen collection tube.
- Shake the specimen collection tube vigorously so as to extract the H. Pylori antigens in the specimen.
After above steps, the specimen is ready for testing, transportation or storage.
Note: It is recommended to test the specimen immediately after extraction. If test is not performed immediately, the extracted specimen may be stored at 2-8°C for up to 3 days. For longer storage, the extracted specimen may be frozen at ≤-20°C. Avoid multiple freeze- thaw cycles (maximum 3 times).
Procedures
- Before testing, open the package and equilibrate the test device, specimens and/or controls to room temperature(15-30°C). Once the specimen is thawed, mix well prior to performing the test.
- Take out the test device from sealed foil pouch and place on a dry, clean and level surface. Be sure to label the device with specimen’s ID number.
- Shake the specimen collection tube vigorously to ensure a homogenous liquid suspension.
- Hold the specimen collection tube vertically. Unscrew the cap. Add 2 drops (approximately 70-90 µL) of the extracted specimen into the specimen well(S) of the test device. Do not overload samples. See illustrations below.
- Start the timer immediately.
- Wait for the colored line to appear. Read test results at 15-20 minutes. Positive results may be visible in as short as 1 minute. Negative results must be confirmed at the end of the 20 minutes only. Do not interpret the result after 20 minutes.
Quality Control
- Internal Control: An internal quality control is included in the test, in the form of a colored line appearing in the control line region (C), indicating that the test is functional, and proper and sufficient volume of specimen has been applied to enable migration through the test and control line, regardless of whether there is a test line or not. If the control line (C) does not appear within the testing time, test result is invalid and the test should be repeated with a new test device.
- External Control: Control standards are not supplied with this kit; however, it is recommended that positive and negative controls be tested as a good laboratory practice to confirm the test procedure and to verify proper test performance.
Results
- Positive: Two lines appear. One colored line should be in the control line region (C) and another apparent colored line should be in the test line region (T).
- Negative: One colored line appears in the control line region (C). No line appears in the test line region (T).
- Invalid: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test device. If the problem persists, stop using the test kit immediately and contact your local distributor.
Specific Characteristics
- Clinical performance: ProDetect™ H. Pylori Antigen Rapid Test has been evaluated using a total of 309 fecal specimens collected from symptomatic patients and healthy individuals. A commercial urea breath test (UBT) is used as the reference test. Test results compared to the UBT assay are presented in the table below.
| ProDetect™ H.Pylori Antigen Rapid Test | UBT Reference | ||
| Positive | Negative | Total | |
| Positive | 105 | 4 | 109 |
| Negative | 3 | 197 | 200 |
| Total | |||
- Analytical Sensitivity (Limit of Detection, LoD)
- Cross-reactivity
| Acinetobacter calcoaceticus | α-hemolytic streptococcus | Proteus vulgaris Hauser |
| Β-hemolytic streptococcus | Pseudomonas aeruginosa | |
| Enterococcus faecalis | Klebsiella pneumonia | Rotavirus |
| Escherichia coli | Moraxella catarrhalis | Salmonella Paratyphi A |
| Gardnerella vaginalis | Neisseria gonorrhea | Salmonella Paratyphi B |
| Geotrichum candidum | Neisseria meningitides | Salmonella Paratyphi C |
| Hemophilus influenza |
- Interference
| Acetaminophen | 20 mg/dl | Caffeine | 20 mg/dl |
| Ascorbic acid | 20 mg/dl | Creatinine | 200 mg/dl |
| Acetylsalicylic acid | 20 mg/dl | Gentistic acid | 20 mg/dl |
| Albumin | 10.5 g/dl | Hemoglobin | 1000 mg/dl |
| Bilirubin | 1,000 mg/dl | Oxilic acid | 600 mg/dl |
| Cholesterol | 800 mg/dl | Triglycerides | 1,600 mg/dl |
Limitation of the Procedure
- ProDetect™ H. Pylori Antigen Rapid Test is only used for the qualitative detection of H. Pylori antigens in human fecal specimens. The intensity of the test line does not have a linear correlation with H. Pylori antigen concentration in the specimen.
- The test does not indicate the quantity of the H. Pylori antigens or the rate of increase of H. Pylori antigen concentration in the specimen and should not be used as the sole criteria for the diagnosis of infection with H. Pylori.
- A negative or non-reactive result may occur if the quantity of the H. Pylori antigens present in a specimen is below the detection limits of the test, or the antigens that are detected are not present in the fecal specimen collected.
- A negative or non-reactive result indicates the H. Pylori antigen is not present in the specimen. However, a negative or non- reactive result does not preclude the possibility of infection with H. Pylori.
- Study found that the seroprevalence of H. Pylori in specimens with positive fecal occult blood (FOB) test results is approximately 39.3%. Accordingly, ProDetect™ H. Pylori Antigen Rapid Test may give positive result when testing a specimen which has been detected positive with a FOB assay.
- If symptoms are suspicious or persist while test result from ProDetect™ H. Pylori Antigen Rapid Test is negative or non- reactive, additional testing using alternative clinical methods is recommended.
- Test results obtained with this test should only be interpreted in conjunction with other diagnostic procedures and clinical findings.
Storage and Safety
- The test kit should be stored either at room temperature or refrigerated (2-30°C), away from direct sunlight. Do not freeze the kit or expose the kit to temperatures over 30°C.
- The shelf life of the kit is as indicated on the outer package (24 months from date of manufacture).
- This test kit is stable until the expiration date marked on the outer package and foil pouch. Ensure all test components are at room temperature (15-30°C) before use.
- Perform the test immediately after taking out the test device from the foil pouch.
Resources
COA