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One Step H Pylori Test

 

       Read the instruction before performing assays. Follow the procedures during testing.

 

 SUMMARY

 

 The infection of Helicobacter pylori ¹ (H. pylori, spiral- shaped bacterium) is associated with a variety of gastro-intestinal diseases, such as stomach ulcer, chronic active gastritis and gastric, duodenal, and gastric denocarcinoma2,3,4,5,6,7,8.    Antibodies to H. pylori are developed in Individuals infected with H. pylori as a serological response 9,10.  Detecting these specific antibodies to H. pylori can be used as a qualitative assay   in the diagnosis of H. pylori infection.  It may be used either as an adjunct to endoscopy or as an alternative measure in symptomatic patients.

 

 PRINCIPLE

　

 The  Diagnostics H. pylori one-step assay is a lateral flow, chromatographic immunoassay (CIA), containing  filter membrane pre-coated with H. pylori specific antigens and colored gold colloidal reagents labeled with H. pylori specific antigens.  There are two regions on the membrane of the test strip, test region (T) and control region (C).  A T line, the burgundy colored band in the test region of membrane,  will be developed rapidly (from 30 seconds to 5 minutes) when antibodies to H. pylori present in specimen.  If antibodies to H. pylori are not present, no T line will be developed in the test region.   A C line, a burgundy colored band in the control region of the test strip, should always appear regardless of the presence of antibodies to H. pylori, serving as a internal qualitative control of the test system.

 

 REAGENTS and MATERIALS

　

 1.   Test Device: Each contains a test strip.

 2.    Dilution buffer.

 

 STORAGE

　

The kit should be stored at room temperature (15-30°C) or refrigerator (2-8°C)  in the sealed pouch  with  desiccant for the duration of the shelf life (18 months).

 

 SPECIMEN COLLECTION

　

 1.  Both fresh whole blood and serum specimen may be tested with this assay.  Following standard clinical procedure to collect   specimens.

 2.  Finger-stick is recommended to collect fresh whole blood specimen for this assay.  Wipe fingertip with alcohol, then prick fingertip with a lancet in a quick motion.

 3.  Serum specimens can be stored at room temperature (20°C to 28°C) for 4 hours,  at 2o-8oC for 48 hours, and  at  -20°C  or lower for prolonged storage.  Repeatedly frozen and thawed specimens  are not recommended for this assay.

 4.  Any sediment in serum specimens should be removed by centrifugation.  Avoid using any turbid specimens, which may be contaminated by microorganisms.

 

 PRECAUTIONS

　

 1.    FOR IN VITRO  USE ONLY.

 2.     Do not use test kit beyond expiration date.

 3.     Do not open the test device foil pouch until you are ready to perform the test.

 4.     Icteric, lipemic, hemolysed, heat treated and contaminated sera may cause erroneous results.

 

PROCEDURE

　

 1. Refrigerated specimens or other materials should be equilibrated to room temperature right before performing assay.

 2.  Remove the device from its protective pouch.  Label the device with specimen identification.

 3.  Add 40ml fresh whole blood (or 20ml serum) of specimens into the sample well.

 4.  Add four drops (about 200 ml) of dilution buffer into the sample well.

 5.  Positive results may be observed as soon as 30 seconds after the specimen reaches the results window,  depending on the concentration of antibodies to H. pylori  in the tested specimen. To confirm negative results, total of 5 minutes, a complete reaction time is required. 

 

INTERPRETATION OF RESULTS

 

       

      Positive: Two pink-rose bands appear: one in the test region (T) and in the control region (C).

      Negative: One rose-pink band appears in the control region (C), with no band in the test region (T).

      Invalid: There is no distinct color band visible both in the test region and in the control region, or there is a visible band only in the test region and not in the control region. The result is invalid due to deterioration of the test or improper test procedure. Repeat the test with a new Testing Device.

 

LImitation

 

 1. This test is a qualitative assay.  To confirm diagnosis of gastritis and/or peptic ulcers, clinical findings need to be considered.

      Serum samples from patients infected with C. Jejuni may have a low  cross-reactivity with this test.

A negative result can not rule out H. pylori  infection.  Because the antibody to H. pylori may be absent or may   be  insufficient  to be detected at the time of  testing.