Testsealabs H.pylori Antibody Rapid Test Cassette/Strip (whole blood/serum/plasma)

Short Description:

Specimen volume: Serum or plasma Specimen: 100 μL
Venipuncture or Fingerstick whole blood specimen: 50 μL
Reading time: 10 minutes;
Relative Sensitivity: 93.8%(88.2%-97.3%)
Relatively Specificity: 89.7%(84.4%-93.7%)
Accuracy: 91.4%(87.8%-94.3%)*


Product Detail

Product Tags

Intended Use

The One Step Dengue NS1 Ag Rapid Test is a rapid chromatographic immunoassay for the qualitative detection of dengue virus NS1 antigen in Whole Blood /Serum / Plasma to aid in the diagnosis of Dengue viral infection.

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Summary

H.Pylori is associated with a variety of gastrointestinal diseases included non-ulcer dyspepsia, duodenal and gastric ulcer and active, chronic gastritis. The prevalence of H. pylori infection could exceed 90% in patients with signs and symptoms of gastrointestinal diseases. Recent studies indicate an association of H. Pylori infection with stomach cancer. H. pylori colonizing in the gastrointestinal system elicits specific antibody responses which aids in the diagnosis of H. Pylori infection and in monitoring the prognosis of the treatment of H. pylori related diseases. Antibiotics in combination with bismuth compounds have been shown to be effective in treating active H. pylori infection. Successful eradication of H. pylori is associated with clinical improvement in patients with gastrointestinal diseases providing a further evidence.

Test Procedure

1.Bring the pouch to room temperature before opening it. Remove the test strip or the cassette from the sealed pouch and use it within one hour
For Test Strip:
1.) Peel off the tape from the test card. and stick the test strip in the middle of test card with arrows pointing down on the test card as illustrated.

2.) Place the strip on a clean and level surface.
For Serum or Plasma specimen:
Hold the dropper vertically and transfer 4 drops of serum or plasma (approximately 100 μL) to the specimen well of test strip and start the timer. See illustration below.
For Venipuncture Whole Blood specimen:
Hold the dropper vertically and transfer 2 drops of whole blood (approximately 50 μL) to the specimen well. then add 1 drop of buffer (approximatel40 μL),and start the timer. See illustration below.
For Fingerstick Whole Blood specimen:
To use a capillary tube: Fill the capillary tube and transfer approximately 50 μL of fingerstick whole blood specimen to the specimen area of test strip, then add 1 drop of buffer (approximately 40 μL) and start the timer. See illustration below.
For Test Cassette:
Place the cassette on a clean and level surface.
For Serum or Plasma specimen:
Hold the dropper vertically and transfer 4 drops of serum or plasma (approximately 100 μL) to the specimen well of rapid test Cassette and start the timer See illustration below.
For Venipuncture Whole Blood specimen:
Hold the dropper vertically and transfer 2 drops of whole blood (approximately 50 μL) to the specimen well, then add 1 drop of buffer (approximately 40 μL) and start the timer See illustration below
For Fingerstick Whole Blood specimen:
To use a capillary tube: Fill the capillary tube and transfer approximately 50μL of fingerstick whole blood specimen to the specimen area of rapid fest cassette, then add 1 drop of buffer (approximately 40 μL) and start the timer. See illustration below.

2.Wait for the colored line(s) to appear. Read results at 10 minutes. Do not interpret the result after 20 minutes

Limitations

1.H.pylori Antibody Rapid Test Cassette/Strip (Whole Blood/Serum/Plasma) is for in vitro diagnostic use only. The test should be used for the detection of H.pylori antibodies in whole blood, serum or plasma specimens only. Neither the quantitative value nor the rate of increase in H.pylori antibody concentration can be determined by this qualitative test.

2.ACCU-TELLH.pylori Antibody Rapid Test Cassette/Strip (Whole Blood/Serum/Plasma) will only indicate the presence of H.pylori antibodies in the specimen and should not be used as the sole criteria for the diagnosis of H.pylori infection.

3.As with all diagnostic tests. all results must be interpreted together with other clinical information available to the physician.

4. If the test result is negative and clinical symptoms persist, additional testing using other clinical methods is recommended. A negative result does not at any time preclude the possibility of H.pylori infection.

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