Colloidal Gold Rapid Antigen Test for Efficient Helicobacter Pylori Antibodies

Rapid And Efficient Detection Of Helicobacter Pylori Antibodies

      The H.Pylori Ab Rapid Test (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of antibodies to H.Pylori in whole blood, serum or plasma to aid in the diagnosis of H.Pylori infection.

Detection Principle

      The H.Pylori Ab Rapid Test Device (Whole Blood/Serum/Plasma) is a qualitative membrane device based immunoassay for the detection of H.Pylori antibodies in whole blood, serum or plasma. In this test, specimen or specimen followed by buffer is added to the specimen well of the test device. The specimen migrates chromatographically along the length of the test strip contained within the device and interacts with the reagents on the strip. If the specimen contains H.Pylori antibodies, a colored line will appear in the test line region indicating a positive result. If the specimen does not contain H.Pylori antibodies, a colored line will not appear in this region indicating a negative result. To serve as a procedural control, a colored line will always appear at the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred.

SPECIMEN COLLECTION AND STORAGE

• The One Step H.pylori Test can be performed used on Whole Blood /Serum / Plasma.
• To collect whole blood, serum or plasma specimens following regular clinical laboratory procedures.
• Separate serum or plasma from blood as soon as possible to avoid hemolysis. Use only clear non-hemolyzed specimens.
• Testing should be performed immediately after specimen collection. Do not leave the specimens at room temperature for prolonged periods. Serum and plasma specimens may be stored at 2-8 for up to 3 days. For long term storage, specimens should be kept below -20. Whole blood should be stored at 2-8 if the test is to be run within 2 days of collection. Do not freeze whole blood specimens.
• Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed and mixed well prior to testing. Specimens should not be frozen and thawed repeated

PROCEDURE

 Allow the test device, specimen, buffer, and/or controls to equilibrate to room temperature (15-30°C) prior to testing.

1.  Remove the test device from the foil pouch and use it as soon as possible. Best results will be obtained if the assay is performed within one hour.
2. Place the test device on a clean and level surface.
3. Hold the dropper vertically and transfer 2 drops of serum or plasma or 3 drops of whole blood to the specimen well (S) of the test device, then add 1 drop of buffer and start the timer.
4. Wait for the red line(s) to appear. The result should be read at 10 minutes. Do not interpret the result after 20 minu

INTERPRETATION OF RESULTS

NOTE:

1. The intensity of the color in test region (T) may vary depending on the concentration of aimed substances present in the specimen. Therefore, any shade of color in the test region should be considered positive. Besides, the substances level can not be determined by this qualitative test.
2. Insufficient specimen volume, incorrect operation procedure, or performing expired tests are the most likely reasons for control band failu

Preservation and stability of products

• The kit should be stored at 2-30°C until the expiry date printed on the sealed pouch. 
• The test must remain in the sealed pouch until use. 
• Do not freeze. 
• Cares should be taken to protect components in this kit from contamination. Do not use if there is evidence of microbial contamination or precipitation. Biological contamination of dispensing equipments, containers or reagents can lead to false results.

KIT COMPONENTS

• Disposable pipettes       For adding specimens use
• Buffer       Phosphate buffered saline and preservative
• Package insert       For operation instruction
• Individually packed test devices       Each device contains a strip with colored conjugates and reactive reagents pre-spreaded at the corresponding regions

MATERIALS REQUIRED BUT NOT PROVIDED

• Specimen collection container       For specimens collection use
• Timer       For timing use
• Centrifuge       For preparation of clear specimens