H. pylori Antibody Rapid Test Cassette immediately and contact your local distributor.

QUALITY CONTROL
(Serum /Plasma) Internal procedural controls are included in the test. A red line appearing in the control region
Package Insert (C) is an internal positive procedural control. It confirms sufficient specimen volume and correct
REF IHP-302 English procedural technique.
Control standards are not supplied with this kit; however, it is recommended that positive and
A rapid test for the qualitative detection of antibody to Helicobacter pylori (H. pylori) in serum or negative controls be tested as a good laboratory practice to confirm the test procedure and to
plasma. verify proper test performance. MITATION
For professional in vitro diagnostic use only. LIMITATIONS
INTENDED USE 1. The H. pylori Antibody Rapid Test Cassette (Serum/Plasma) is for in vitro diagnostic use
The H. pylori Antibody Rapid Test Cassette (Serum/Plasma) is a rapid chromatographic only. This test should be used for the detection of H. pylori antibody in serum or plasma
immunoassay for the qualitative detection of Antibody to H. pylori in serum or plasma. specimen. Neither the quantitative value nor the rate of increase in H. pylori antibody
SUMMARY concentration can be determined by this qualitative test.
H. pylori is a small, spiral-shaped bacterium that lives in the surface of the stomach and 2. The H. pylori Antibody Rapid Test Cassette (Serum/Plasma) will only indicate the presence
duodenum. It is implicated in the etiology of a variety of gastrointestinal diseases, including of H. pylori antibodies in the specimen and should not be used as the sole criteria for the
duodenal and gastric ulcer, non-ulcer dyspepsia and active and chronic gastritis.1,2 Both diagnosis of H. pylori infection.
invasive and non-invasive methods are used to diagnose H. pylori infection in patients with 3. As with all diagnostic tests, all results must be interpreted together with other clinical
symptoms of gastrointestinal disease. Specimen-dependent and costly invasive diagnostic information available to the physician.
methods include gastric or duodenal biopsy followed by urease testing (presumptive), culture, 4. If the test result is negative and clinical symptoms persist, additional testing using other
and/or histologic staining.3 Non-invasive techniques include the urea breath test, which clinical methods is recommended. A negative result does not at any time preclude the
requires expensive laboratory equipment and moderate radiation exposure, and serological possibility of H. pylori infection.
methods.4,5 Individuals infected with H. pylori develop antibodies which correlate strongly with EXPECTED VALUES
histological confirmed H. pylori infection.6,7,8 The H. pylori Antibody Rapid Test Cassette (Serum/Plasma) has been compared with a
The H. pylori Antibody Rapid Test Cassette (Serum/Plasma) is a simple test that utilizes a leading commercial H. pylori antibody ELISA test. The correlation between these two systems
combination of H. pylori antigen coated particles and anti-human IgG to qualitatively and is 93.7%.
selectively detect H. pylori antibodies in serum or plasma. PERFORMANCE CHARACTERISTICS
PRINCIPLE Sensitivity and Specificity
The H. pylori Antibody Rapid Test Cassette (Serum/Plasma) is a qualitative membrane based The H. pylori Antibody Rapid Test Cassette (Serum/Plasma) has been evaluated with serum
immunoassay for the detection of H. pylori antibodies in serum or plasma. In this test and plasma specimens obtained from a population of symptomatic and asymptomatic
procedure, anti-human IgG is immobilized in the test line region of the test. After specimen is individuals who presented for endoscopic examination.
added to the specimen well of the cassette, it reacts with H. pylori antigen coated particles in Method ELISA Total
the test. This mixture migrates chromatographically along the length of the test and interacts Results Positive Negative Results
H. pylori Antibody Rapid Test
with the immobilized anti-human IgG. If the specimen contains H. pylori antibodies, a colored Positive 211 14 225
Cassette(Serum/Plasma)
line will appear in the test line region indicating a positive result. If the specimen does not Negative 10 146 156
contain H. pylori antibodies, a colored line will not appear in this region indicating a negative Total Results 221 160 381
result. To serve as a procedural control, a colored line will always appear in the control line Relative Sensitivity: 95.9% (95%CI*: 91.8%-97.8%) *Confidence Interval
region, indicating that proper volume of specimen has been added and membrane wicking has Relative Specificity: 95.5% (95%CI*: 85.7%-97.6%)
occurred. Overall Accuracy: 95.7% (95%CI*: 90.8%-96.9%)
REAGENTS Precision
The test cassette contains H. pylori antigen coated particles and anti-human IgG coated on the Intra-Assay
membrane. Within-run precision has been determined by using 10 replicates of 4 specimens: a negative, a
PRECAUTIONS low positive, a medium positive and a high positive. The negative, low positive, medium
Please read all the information in this package insert before performing the test. positive and high positive values were correctly identified >99% of the time.
1. For professional in vitro diagnostic use only. Do not use after the expiration date. Inter-Assay
2. Do not eat, drink or smoke in the area where the specimen or kits are handled. Between-run precision has been determined by 10 independent assays on the same 4
3. Handle all the specimens as if they contain infectious agents. Observe established specimens: a negative, a low positive, a medium positive and a high positive. Three different
precautions against microbiological hazards throughout testing and follow the standard lots of the H. pylori Test Cassette (Serum/Plasma) have been tested using negative,
procedures for proper disposal of specimens. low positive medium positive and high positive specimens. The specimens were
4. Wear protective clothing such as laboratory coats, disposable gloves and eye protection correctly identified >99% of the time.
when specimens are being tested. Cross-reactivity
5. Humidity and temperature can adversely affect results. Sera containing known amounts of antibodies to H. pylori have been tested with Hepatitis A, B
STORAGE AND STABILITY ,C, E, HIV and Syphilis. No cross-reactivity was observed, indicating that the H.
Store as packaged at room temperature or refrigerated (2-30°C). The test is stable through the pylori Test Cassette (Serum/Plasma) has a high degree of specificity for human
expiration date printed on the sealed pouch. The test must remain in the sealed pouch until use. antibodies to H.
DO NOT FREEZE. Do not use beyond the expiration date. pylori.
SPECIMEN COLLECTION AND PREPARATION Interfering Substances
1. The H. pylori Antibody Rapid Test Cassette (Serum/Plasma) can be performed using serum The H. pylori Antibody Rapid Test Cassette (Serum/Plasma) has been tested for
or plasma. possible interference from visibly hemolyzed and lipemic specimens, as well as specimens
2. Separate serum or plasma from blood as soon as possible to avoid hemolysis. Use only containing high bilirubin levels. In addition, no interference was observed in specimens
clear, non-hemolyzed specimens. containing up to 1,000 mg/dL hemoglobin, up to 1,000 mg/dL bilirubin, and up to 2,000
3. Testing should be performed immediately after specimen collection. Do not leave the mg/dL human serum albumin.
specimens at room temperature for prolonged periods. Serum and plasma specimens may BIBLIOGRAPHY
be stored at 2-8°C for up to 3 days. For long term storage, specimens should be kept below 1. Marshall, BJ, McGechie, DB, Rogers, PAR and Glancy, RG. Pyloric Campylobacter infection
-20°C. and gastroduodenal disease. Med. J. Australia. 149: 439-44; 1985.
4. Bring specimens to room temperature prior to testing. Frozen specimens must be 2. Soll, AH. Pathogenesis of peptic ulcer and implications for therapy. New England J. Med.
completely thawed and mixed well prior to testing. Specimens should not be frozen and 322:909-16; 1990.
thawed repeatedly. 3. Hazell, SL, et al. Campylobacter pyloridis and gastritis I: Detection of urease as a marker of
5. If specimens are to be shipped, they should be packed in compliance with federal bacterial colonization and gastritis. Amer. J. Gastroenterology. 82(4): 292-96; 1987.
regulations covering the transportation of etiologic agents. 4. Loffeld, RJLF, et al. Usefulness of several commercial enzyme-linked immunoassays for
MATERIALS detection of Helicobacter pylori infection in clinical medicine. Euro. J. Gastroen. Hepa.
Materials provided 5:333-37; 1993.
• Test Cassettes • Droppers • Package Insert 5. Cutler, AF, et al. Accuracy of invasive and non-invasive tests to diagnose Helicobacter pylori
Materials required but not provided infection. Gastroenterology. 109: 136-141; 1995.
• Specimen collection containers • Centrifuge • Timer 6. Ansorg, R, Von Recklinghausen, G, Pomarius, R and Schmid, EN. Evaluation of techniques
DIRECTIONS FOR USE for isolation, subcultivation and preservation of Helicobacter pylori. J. Clin. Micro. 29:51-53;
Allow test cassette, serum or plasma specimen, and/or controls to equilibrate to room 1991.
temperature (15-30℃) prior to testing. 7. Pronovost, AP, Rose, SL, Pawlak, J, Robin, H and Schneider, R. Evaluation of a new
1. Remove the test cassette from the sealed foil pouch and use it as soon as possible. Best immunodiagnostic assay for Helicobacter pylori antibody detection: Correlation with
results will be obtained if the assay is performed immediately after opening the foil pouch. histopathological and microbiological results. J. Clin. Micro. (1994), 32: 46-50.
2. Hold the dropper vertically and transfer 3 drops of serum or plasma (approximately 75 L) 8. Megraud, F, Bassens-Rabbe, MP, Denis, F, Belbouri, A and Hoa, DQ. Seroepidemiology of
to the specimen well of test cassette and start the timer. Avoid trapping air bubbles in the Campylobacter
Attention, pylori Indexpopulations.
infectionforin various
see instructions of Symbols J. Clin. Micro. 27: 1870-3; 1989.
Authorized
Tests per kit
specimen well. See illustration below. use Representative
3. Wait for the colored line is appeared. The result should be read at 10minutes. Do not For in vitro
Use by Do not reuse
interpret the result after 20 minutes. diagnostic use only

Store between 2-30°C Lot Number Catalog #

Do not use if package is Consult Instructions For

Manufacturer
damaged Use

INTERPRETATION OF RESULTS
(Please refer to the illustration above)
POSITIVE:* Two distinct colored lines appear. One colored line should be in the control
DN: 848300
region (C) and another colored line should be in the test region (T).
Rev.Date: 2018-06-21
*NOTE: The intensity of the color in the test line region (T) will vary depending on the
concentration of H. pylori antibody present in the specimen. Therefore, any shade of color in
the test region (T) should be considered positive.
NEGATIVE: One colored line appears in the control region (C). No apparent colored line
appears in the test region (T).
INVALID: Control line fails to appear. Insufficient specimen volume or incorrect procedural
techniques are the most likely reasons for control line failure. Review the procedure and repeat
the test with a new test cassette. If the problem persists, discontinue using the test kit