The H. pylori Rapid Test Device (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassayforthe qualitative detection of IgG antibodies to Helicobacter pylori in whole blood, serum or plasma to aid in the diagnosis of H.pylori infection in adults 18years of age and older.
H. pylori Antibodies Test Cassette
1. Product Details
Product Name: The H. pylori Antibodies Test Cassette
Test Item: IgG Antibodies to Helicobacter Pylori
Specimen: Whole Blood/Serum/Plasma
The H. pylori Antibodies Test Cassette (Whole Blood/Serum/Plasma) is a qualitative membrane cassette based immunoassay for the detection of H. pylori IgG antibodies in whole blood, serum or plasma. In this test procedure, anti-human IgG is immobilized in the test line region of the device. The sample reacts with H. pylori antigen coated particles that have been applied to the label pad. This mixture migrates chromatographically along the length of the test strip and interacts with the immobilized anti-human IgG. If the sample contains H. pylori IgG antibodies, a colored line will appear in the test line region indicating a positive result. If the sample does not contain H. pylori IgG 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.
3. Directions for Use
Allow the test device, sample, buffer, and 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 immediately after opening the foil pouch.
(2) Place the test device on a clean and level surface.
For Whole Blood (Venipuncture) samples: Hold the dropper vertically and transfer 2 drops of whole blood (approximately 50μl) to the sample well (S) of the test device, then add 1 drop of Sample Buffer to the sample well. Start the timer.
For Whole Blood (Fingerstick) samples: Transfer one capillary tube of blood (approximately 50μl) to the sample well (S) of the test device, then add 1 drop of Sample Buffer to the sample well. Start the timer.
For Serum or Plasma samples: Hold the dropper vertically and transfer 2 drops of serum or plasma (approx. 50μl) and 1 drop of Sample Buffer to the sample well (S) of the test device, and start the timer. Avoid trapping air bubbles in the sample well (S). See the illustration below.
(3) Wait for the red line(s) to appear. The result should be read at 10 minutes. It is important that the background is clear before the result is read.
Note: Low titers of H. pylori IgG antibodies might result in a faint line appearing in the test region (T) after an extended period of time, therefore, do not interpret the result after 15 minutes.
Hangzhou Laihe Biotech Co., Ltd
Address: Room 521 Floor 5 & Floor 1,Building No. 2B,Tianhe High-Tech Park,No. 688,Bin'an Road,Changhe Sub-district,Binjiang District,Hangzhou City,Zhejiang Province,China