Specimen Preparation: Blood samples may be collected by fingerstick or venipuncture.
Use clear non-hemolyzed specimens only.
For serum samples, collect blood in a tube containing anticoagulant and allow it to clot.
For plasma samples, collect blood in a tube containing anticoagulant.
For whole blood samples, collect blood in a tube containing anticoagulant. Whole blood samples should be tested immediately after collection.
The blood sample may be stored at 2-8°C for up to three days if the tests cannot be performed immediately. Ensure that the blood samples be brought to room temperature prior to use.
Test Procedures: 1. Remove the testing device from the sealed pouch by tearing at the notch and place the testing device on a leveled surface.
2. Hold the sample dropper vertically. Add 1 drop (40 µl) of the specimen without air bubbles into the Sample Well that is marked with an arrow on the testing device;
Wait for 20-30 sec. Add 2 drops (90 µl) of the assay buffer to the same Sample Well of the testing device.
3. Read the results in 10 minutes. Read results as shown under Interpretation of Results.
NOTE: Specimens with high concentrations of H. pylori antibodies may produce positive results in as little as 1 minute. Confirm negatives in 20 minutes.
DO NOT INTERPRET RESULTS AFTER 30 MINUTES.
Result Interpretations: See figure.
Click on icon to see table/diagram/image
Negative: A pink colored band appears only at the control region (C), indicating a negative result for H. pylori Infections.
Positive: A clear pink control band (C) and a detectable test band (T) appears, indicating a positive result for H. pylori infections.
Invalid: No visible band at the control region (C). Repeat with a new test device. If test still fails, contact the distributor with the lot number.
Quality Control: Although the testing device contains an internal quality control (pink colored band in the control region), good laboratory practice recommends the daily use of an outside control to ensure proper testing device performance. Quality control samples should be tested according to the standard quality control requirements established by the laboratory.
Limitations: Humidity and temperature can adversely affect results.
There is always a possibility that false results will occur due to the presence of interfering substances in the specimen or factors beyond the control of the manufacturer, such as technical or procedural errors associated with the testing.
Although the test demonstrates superior accuracy in detecting HP antibody, a low incidence of false results can occur. Therefore, other clinically available tests are required in case of questionable results. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the results of a single test, but should only be made by the physician after all clinical and laboratory findings have been evaluated.