Accu-Tell^® H. pylori IgG Cassette/Strip (Whole Blood/Serum/Plasma)

Product Description

CATALOG

KEY POINTS

Detection for: IgG antibodies to H. pylori in whole blood, serum or plasma

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%) *          

INTRODUCTION

H.pylori is a small, spiral-shaped bacterium that lives in the surface of the stomach and duodenum. It is implicated in the etiology of a variety of gastrointestinal diseases, including duodenal and gastric ulcer, non-ulcer dyspepsia and active and chronic gastritis. Both invasive and non-invasive methods are used to diagnose H.pylori infection in patients with symptoms of gastrointestinal disease.

INTENDED USE

ACCU-TELL^® H. pylori IgG Cassette/Strip (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of IgG antibodies to H.pylori in whole blood, serum, or plasma to aid in the diagnosis of H.pylori infection.

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 (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 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 test 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.

PERFORMANCE CHARACTERISTICS

Clinical Sensitivity, Specificity and Accuracy

ACCU-TELL^® H. pylori IgG Cassette/Strip (Whole Blood/Serum/Plasma)  has been evaluated with specimens obtained from a population of symptomatic and asymptomatic individuals who presented for endoscopic examination. Biopsy (Culture) served as the reference method for ACCU-TELL^® H. pylori IgG Cassette/Strip (Whole Blood/Serum/Plasma). Histology and a Rapid Urease Test (RUT) were performed on all negative culture specimens. The specimen was considered positive if Culture was positive. The specimen was also considered positive if the Culture was negative, but both Histology and RUT were positive. The result shows that the sensitivity of ACCU-TELL^® H. pylori IgG Cassette/Strip (Whole Blood/Serum/Plasma) is 93.8% and the specificity is 89.7% relative to Biopsy/Histology/RUT.

ACCU-TELL^® H. pylori IgG Cassette/Strip (Whole Blood/Serum/Plasma) vs. Biopsy/ Histology/RUT

Relative Sensitivity: 93.8% (88.2%-97.3%)*  

Relatively Specificity: 89.7% (84.4%-93.7%)*

Accuracy: 91.4% (87.8%-94.3%) *           

*95% Confidence Intervals

Precision

Intra-Assay

Within-run precision has been determined by using 10 replicates of four specimens: a negative, a low positive, a medium positive and a high positive. The negative, low positive, medium positive and high positive values were correctly identified >99% of the time.

Inter-Assay

Between-run precision has been determined by 10 independent assays on the same four specimens: a negative, a low positive, a medium positive and a high positive. Three different lots of ACCU-TELL^® H. pylori IgG Cassette/Strip (Whole Blood/Serum/Plasma) have been tested using negative, low positive, medium positive and high positive specimens. The specimens were correctly identified >99% of the time

Cross-reactivity

Sera containing known amounts of antibodies to H. pylori have been tested with Hepatitis A, B, C, E, HIV and Syphilis. No cross-reactivity was observed, indicating that ACCU-TELL^® H. pylori IgG Cassette/Strip (Whole Blood/Serum/Plasma) has a high degree of specificity for antibodies to H. pylori.

Interfering Substances

ACCU-TELL^® H. pylori IgG Cassette/Strip (Whole Blood/Serum/Plasma) has been tested for possible interference from visibly hemolyzed and lipemic specimens, as well as serum specimens containing high bilirubin levels. In addition, no interference was observed in specimens containing up to 1,000 mg/dL hemoglobin; up to 1,000 mg/dL bilirubin; and up to 2,000 mg/dL human serum albumin.

LIMITATIONS

1. ACCU-TELL^® H. pylori IgG 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-TELL^® H. pylori IgG 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.

Note: The above information is for reference use only. Please refer to the product insert provided with the products before use.