INTEND USE
Vstrip H. pylori Antigen Rapid Test is a single use immunochromatographic assay for the qualitative detection of H. pylori antigen in unpreserved human stool specimens. Test results are intended to aid in the initial diagnosis and treatment of H. pylori infection. Test results should be taken into consideration by the physician in conjunction with the patient history and symptoms.

FEATURES

Method: Monoclonal immunochromatographic assay
Specimen: Stool
Detection device: Cassette
Time to Result: 10 minutes
External Quality Control: Positive control reagent
Package: 20 tests/kit
Storage temperature: 15-30℃
 

PERFORMANCE CHARACTERISTICS
The evaluation was conducted comparing the results obtained using Vstrip H. pylori Antigen Rapid Test to an FDA-cleared ELISA that was previously evaluated relative to the endoscopy biopsy composite reference method (i.e., culture, histology, and RUT) for initial H. pylori diagnosis with a demonstrated sensitivity and specificity greater than or equal to 95% and a lower bound of the two-sided 95% confidence interval (CI) greater than 89%.

Percent Positive Agreement: 96.67% (58/60= 96.67%)
(95% Two-Sided CI: 88.6-99.1%)
Percent Negative Agreement: 98.17% (268/273= 98.17%)
(95% Two-Sided CI: 95.8-99.2%)

ANALYTICAL SENSITIVITY(DETECTION LIMIT)

The test showed the limit of detection level was around 8.5 X10⁵ CFU/mL for H. pylori strain (ATCC 43504) in stool.

CROSS REACTIVITY

The cross reactivity of the Vstrip H. pylori Antigen Rapid Test was assessed by testing the following microorganisms (bacteria spiked at ≥1x10⁷ CFU/mL, viruses spiked at ≥1x10⁵ TCID₅₀/mL). None of the microorganisms tested in the following table gave a positive result in the Vstrip H. pylori Antigen Rapid Test.


LIMITATIONS OF THE PROCEDURE

1. A negative test result may occur if the level of antigen in a stool sample is below the detection limit of the test. Test results must be evaluated in conjunction with other clinical data available to the physician.
2. An excess of stool sample could cause an invalid result or may cause the appearance of brown bands.
3. A false negative result may be found in specimens with watery diarrheal stools that compose little or no solid matter.
4. A negative test result does not rule out the possibility of H. pylori infection for not all H. pylori strains can be detected by the kit.
5. False negative results may occur due to improper or inadequate sampling, or improper handling of the specimen.
6. Higher concentration of the tested interfering substances or substances other than what have been examined may exist in the stool specimen and interfere the test result.
7. Cross reactivity has not been evaluated for microorganisms other than what have been described below.
8. A positive test result does not rule out co-infections with other pathogens.
9. A positive test result only indicates the presence of H. pylori antigen and does not necessarily indicate that gastrointestinal disease is present.
10. Antimicrobials, proton pump inhibitors (PPIs) and bismuth compounds are known to suppress H. pylori and may give a false negative result if ingested in the 14 days prior to sample collection. In these cases, a new stool sample should be collected and tested 14 days after treatment has stopped. Positive results from patients that have used antibiotics, PPIs, or bismuth compounds in the 14 days prior to stool sample collection are still considered accurate.

 

CERTIFICATION

ISO 13485:2016
CE Mark
TFDA
FDA 510(k)