MedEx H. Pylori Antibody Rapid Test Cassette Description

A rapid test for the qualitative detection of antibodies to Helicobacter pylori (H. pylori) in humanwhole blood, serum, or plasma. For professional in vitro diagnostic use only.
Materials provided: Test cassettes, Droppers, Buffer, Package insert.
Materials required but not provided: Specimen collection containers, Centrifuge, Lancets (for fingerstick whole blood only), Timer, Heparinized capillary tubes and dispensing bulb (for fingerstick whole blood only).
Performance Characteristics: Clinical Sensitivity, Specificity, and Accuracy: The H. pylori Antibody Rapid Test Cassette (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 the H. pylori Antibody Rapid Test Cassette (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 the H. pylori Antibody Rapid Test Cassette (Whole Blood/Serum/Plasma) is 96.8% and the specificity is 93.0% relative to Biopsy/Histology/RUT. (See table.)

Click on icon to see table/diagram/image

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 the H. pylori Antibody Rapid Test Cassette (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 the H. pylori Antibody Rapid Test Cassette (Whole Blood/Serum/Plasma) has a high degree of specificity for antibodies to H. pylori.