Materials Required But Not Provided Of the 321 fresh clinical samples collected, 136 were considered biopsy

samples collected, 136 were considered biopsy positive and 185 clinical
• Specimen collection containers • Lancets (for fingerstick whole blood only) specimens were considered biopsy negative. Biopsy “positive” was defined as either or both culture
and histology are positive and biopsy “negative” was defined as both culture and histology negative.
• Centrifuge • Timer
Effective date: 2014-12-30 Number: 1155867904 • Heparinized capillary tubes and dispensing bulb (for fingerstick whole blood only)
The results for each sample matrix are summarized below.
H. pylori Rapid Test Device vs. Biopsy/Histology
DIRECTIONS FOR USE SERUM
H. pylori Rapid Test Device Allow the test, specimen, buffer, and/or controls to reach room temperature (15-30°C) prior to testing. Method Biopsy/Histology
1. Bring the pouch to room temperature before opening it. Remove the test device from the sealed
(Whole Blood/Serum/Plasma) pouch and use it as soon as possible. H. pylori
Results Positive Negative
Package Insert 2. Place the test device on a clean and level surface. Positive 121 21
Test Device
For Serum or Plasma specimens: Hold the dropper vertically and transfer 2 drops of serum or Negative 15 164
English plasma (approximately 50 µL) to the specimen well (S) of the test device, then add 1 drop of buffer Sensitivity = 121/136 = 89% (82%-94%)* Specificity = 164/185 = 89% (83%-93%)*
A rapid test for the qualitative detection of antibodies to Helicobacter pylori (H. pylori) in whole blood, to the specimen well (S). Start the timer. See illustration below. Accuracy = 285/321 = 89% (85%-92%)*
serum, or plasma. For Venipuncture Whole Blood specimens: Hold the dropper vertically and transfer 2 drops of PLASMA
For professional in vitro diagnostic use only. whole blood (approximately 50 µL) to the specimen well (S) of the test device, then add 1 drop of Method Biopsy/Histology
INTENDED USE buffer and start the timer. See illustration below.
For Fingerstick Whole Blood specimens: Fill the capillary tube and transfer approximately 50 µL of Results Positive Negative
The H. pylori Rapid Test Device (Whole Blood/Serum/Plasma) is a rapid chromatographic H. pylori
fingerstick whole blood to the specimen well (S) of the test device, then add 1 drop of buffer and start Positive 120 21
immunoassay for the qualitative detection of antibodies to H. pylori in whole blood, serum, or plasma Test Device
the timer. See illustration below. Negative 16 164
to aid in the diagnosis of H. pylori infection in adults 18 years of age and older. 3. Wait for the colored line(s) to appear. Read results at 10 minutes. Do not interpret the result after 15 minutes. Sensitivity = 120/136 = 88% (81%-93%)* Specificity = 164/185 = 89% (83%-93%)*
SUMMARY Accuracy = 284/321 = 88% (84%-92%)*
H. pylori is a small, spiral-shaped bacterium that lives in the surface of the stomach and duodenum. It is FINGERSTICK
implicated in the etiology of a variety of gastrointestinal diseases, including duodenal and gastric ulcer, Method Biopsy/Histology
non-ulcer dyspepsia and active and chronic gastritis.1,2 Both invasive and non-invasive methods are Results Positive Negative
used to diagnose H. pylori infection in patients with symptoms of gastrointestinal disease. Specimen- H. pylori Positive 54 12
dependent and costly invasive diagnostic methods include gastric or duodenal biopsy followed by Test Device
urease testing (presumptive), culture, and/or histologic staining.3 Non-invasive techniques include the Negative 8 76
urea breath test, which requires expensive laboratory equipment and moderate radiation exposure, and Sensitivity = 54/62 = 87% (76%-94%)* Specificity = 76/88 = 86% (77%-93%)*
serological methods.4,5 Individuals infected with H. pylori develop antibodies which correlate strongly Accuracy = 130/150 = 87% (80%-92%)*
with histologically confirmed H. pylori infection.6,7,8 VENOUS WHOLE BLOOD
The H. pylori Rapid Test Device (Whole Blood/Serum/Plasma) is a simple test that utilizes a Method Biopsy/Histology
combination of H. Pylori antigen coated particles and anti-human IgG to qualitatively and selectively Results Positive Negative
detect H. pylori antibodies in whole blood, serum, or plasma in just minutes. H. pylori Positive 119 22
Test Device
PRINCIPLE Negative 17 163
The H. pylori Rapid Test Device (Whole Blood/Serum/Plasma) is a qualitative membrane based Sensitivity = 119/136 = 88% (81%-93%)* Specificity = 163/185 = 88% (83%-92%)*
immunoassay for the detection of H. pylori antibodies in whole blood, serum, or plasma. In this test Accuracy = 282/321 = 88% (84%-91%)* *Denotes 95% Confidence Interval
procedure, anti-human IgG is immobilized in the test line region of the test. After specimen is added to the POL Studies
specimen well of the device, it reacts with H. pylori antigen coated particles in the test. This mixture migrates Three physicians’ offices were used to conduct an evaluation of the H. pylori Rapid Test Device (Whole
chromatographically along the length of the test and interacts with the immobilized anti-human IgG. If the INTERPRETATION OF RESULTS Blood/Serum/Plasma). Personnel with various educational backgrounds performed the testing. Each
specimen contains H. pylori antibodies, a colored line will appear in the test line region indicating a positive (Please refer to the illustration above) physician’s office tested a randomly coded panel of samples consisting of negative (20), low positive (20)
result. If the specimen does not contain H. pylori antibodies, a colored line will not appear in this region POSITIVE:* Two lines appear. One colored line should be in the control line region (C) and another and medium positive (20) for three days. The results obtained had a >99% correlation with the expected
indicating a negative result. To serve as a procedural control, a colored line will always appear in the control apparent colored line should be in the test line region (T). results.
line region, indicating that proper volume of specimen has been added and membrane wicking has occurred. *NOTE: The intensity of the color in the test line region (T) will vary depending on the concentration Cross-Reactivity
REAGENTS of H. pylori antibodies in the specimen. Therefore, any shade of color in the test line region (T) should Sera containing known amounts of IgG antibodies to H. pylori have been tested with C. jejuni, C. fetus,
The test contains H. pylori antigen coated particles and anti-human IgG coated on the membrane. be considered positive. C. coli, P. aeruginosa and E. coli. No cross-reactivity was observed, indicating that the H. pylori Rapid
NEGATIVE: One colored line appears in the control line region (C). No line appears in the test line Test Device (Whole Blood/ Serum/ Plasma) has a high degree of specificity for human serum IgG
PRECAUTIONS antibodies to H. pylori.
region (T).
• For professional in vitro diagnostic use only. Do not use after the expiration date. Interference Studies
• Do not eat, drink or smoke in the area where the specimens or kits are handled. 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 No interference with the H. pylori Rapid Test Device (Whole Blood/Serum/ Plasma) results was
• Do not use test if pouch is damaged. observed in samples containing high levels of hemoglobin (up to 1000 mg/dL), bilirubin (up to 1000
• Handle all specimens as if they contain infectious agents. Observe established precautions against with a new test. If the problem persists, discontinue using the test kit immediately and contact your
local distributor. mg/dL) and human serum albumin (up to 2000 mg/mL). The test results were also unaffected when the
microbiological hazards throughout testing and follow the standard procedures for proper disposal of hematocrit was altered ranging from 20% to 67%. 600mg/dL triglyceride concentration sample did not
specimens. QUALITY CONTROL
interfere with test performance.
• Wear protective clothing such as laboratory coats, disposable gloves and eye protection when An internal procedural control is included in the test. A colored line appearing in the control line
specimens are being tested. BIBLIOGRAPHY
region (C) is an internal positive procedural control. It confirms sufficient specimen volume, adequate
• The used test should be discarded according to local regulations. membrane wicking and correct procedural technique. 1. Marshall, BJ, McGechie, DB, Rogers, PAR and Glancy, RG. Pyloric Campylobacter infection and
• Humidity and temperature can adversely affect results. Control standards are not supplied with this kit; however, it is recommended that positive and negative controls gastroduodenal disease. Med. J. Australia. (1985), 149: 439-44.
be tested as a good laboratory practice to confirm the test procedure and to verify proper test performance. 2. Soll, AH. Pathogenesis of peptic ulcer and implications for therapy. New England J. Med. (1990), 322: 909-16.
STORAGE AND STABILITY
3. Hazell, SL, et al. Campylobacter pyloridis and gastritis I: Detection of urease as a marker of bacterial
Store as packaged in the sealed pouch at room temperature or refrigerated (2-30°C). The test is stable LIMITATIONS colonization and gastritis. Amer. J. Gastroenterology. (1987), 82(4): 292-96.
through the expiration date printed on the sealed pouch. The test must remain in the sealed pouch until 1. The H. pylori Rapid Test Device (Whole Blood/ Serum/Plasma) should be used only to evaluate patients 4. Loffeld, RJLF, et al. Usefulness of several commercial enzyme-linked immunoassays for detection of Helicobacter
use. DO NOT FREEZE. Do not use beyond the expiration date. with clinical signs and symptoms suggestive of gastrointestinal disease and is not intended for use with pylori infection in clinical medicine. Euro. J. Gastroen. Hepa. (1993) 5:333-37.
SPECIMEN COLLECTION AND PREPARATION asymptomatic patients. 5. Cutler, AF, et al. Accuracy of invasive and non-invasive tests to diagnose Helicobacter pylori infection.
2. The H. pylori Rapid Test Device (Whole Blood/Serum/Plasma) is for in vitro diagnostic use only. The Gastroenterology.(1995), 109: 136-141.
• The H. pylori Rapid Test Device (Whole Blood/Serum/Plasma) can be performed using whole blood test should be used for the detection of H. pylori antibodies in whole blood, serum or plasma specimens 6. Ansorg, R, Von Recklinghausen, G, Pomarius, R and Schmid, EN. Evaluation of techniques for isolation,
(from venipuncture or fingerstick), serum, or plasma. only. Neither the quantitative value nor the rate of increase in H. pylori antibody concentration can be subcultivation and preservation of Helicobacter pylori. J. Clin. Micro. (1991), 29:51-53.
• To collect Venipuncture Whole Blood specimens: Collect anti-coagulated blood specimen (sodium determined by this qualitative test. 7. Pronovost, AP, Rose, SL, Pawlak, J, Robin, H and Schneider, R. Evaluation of a new immunodiagnostic assay for
or lithium heparin, potassium or sodium EDTA, sodium oxalate, sodium citrate) following standard 3. The H. pylori Rapid Test Device (Whole Blood/Serum/Plasma) will only indicate the presence of H. pylori Helicobacter pylori antibody detection: Correlation with histopathological and microbiological results. J. Clin.
laboratory procedures. antibodies in the specimen and should not be used as the sole criteria for the diagnosis of H. pylori infection. Micro. (1994), 32: 46-50.
• To collect Fingerstick Whole Blood specimens: 4. Grossly hemolysed samples will yield invalid results. Strictly follow the Package Insert instructions to 8. Megraud, F, Bassens-Rabbe, MP, Denis, F, Belbouri, A and Hoa, DQ. Seroepidemiology of Campylobacter pylori
• Wash the patient’s hand with soap and warm water or clean with an alcohol swab. Allow to dry. obtain accurate results. infection in various populations. J. Clin. Micro. (1989), 27: 1870-3.
• Massage the hand without touching the puncture site by rubbing down the hand towards the 5. A positive result does not allow one to distinguish between active infection and colonization by H. pylori. 9. Lotfeld, R.J.L.F., E. Slobberingh, J.P. Van Spreeuwel, J.A. Flendrig, & J.W. Arends. The prevalence of anti-
fingertip of the middle or ring finger. 6. A positive result only indicates the presence of IgG antibody to H. pylori and does not necessarily indicate Helicobacter (Campylobacter) pylori antibodies in patients and healthy blood donors. J. Med. Microbiol. (1991),
• Puncture the skin with a sterile lancet. Wipe away the first sign of blood. that gastrointestinal disease is present. 32:105-109.
• Gently rub the hand from wrist to palm to finger to form a rounded drop of blood over the puncture site. 7. A negative result indicates that IgG antibody to H. pylori is not present or is below the detection limit of the 10.Graham, D.Y. H.M. Malaly, D.G. Evans, D.J. Evans, Jr., P.D. Klein, & E. Adam. Epidemiology of Helicobacter
• Add the Fingerstick Whole Blood specimen to the test by using a capillary tube: test. pylori in an asymptomatic population in the United States. Effect of age, race, and socioeconomic status.
• Touch the end of the capillary tube to the blood until filled to the line. Avoid air bubbles. 8. As with all diagnostic tests, all results must be interpreted together with other clinical information Gastroenterology. (1991), 100:1495-1501.
• Place the bulb onto the top end of the capillary tube, then squeeze the bulb to dispense the whole available to the physician. 11.Perez-Perez, G, Dworkin, B, Chodos, J, Blaser, M. Campylobacter pylori antibodies in humans. Annals of Internal
blood to the specimen well (S) of the test device. 9. Literature references have suggested cross reactivity of IgG antibody with a closely related organism, Med. (1988), 109:11-17.
• Separate serum or plasma from blood as soon as possible to avoid hemolysis. Use only clear, non- Borrelia burgdorferi. Performance of this assay has not been evaluated with this organism. Therefore, the
hemolyzed specimens. specificity of this test device is not known if this organism is encountered. Index of Symbols
• Testing should be performed immediately after specimen collection. Do not leave the specimens at 10.If the test result is negative and clinical symptoms persist, additional testing using other clinical methods Consult instructions for Authorized
room temperature for prolonged periods. Serum and plasma specimens may be stored at 2-8°C for up Tests per kit
is recommended. A negative result does not at any time preclude the possibility of H. pylori infection. use Representative
to 3 days. For long term storage, specimens should be kept below -20°C. Whole blood collected by 11.This assay has not been established for patients under 18 years of age. For in vitro
venipuncture should be stored at 2-8°C if the test is to be run within 2 days of collection. Do not EXPECTED VALUES Use by Do not reuse
freeze whole blood specimens. Whole blood collected by fingerstick should be tested immediately. diagnostic use only
• Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed H. pylori infection is present worldwide and has been shown to correlate with age, ethnic background,
family size, and socioeconomic class.9 In the United States, the incidence of infection may increase 1- Store between 2-30°C Lot Number REF Catalog #
and mixed well prior to testing. Specimens should not be frozen and thawed repeatedly.
• If specimens are to be shipped, they should be packed in compliance with local regulations covering 2% annually.10 Eighty to 100% of individuals with signs and symptoms of other gastrointestinal
the transportation of etiologic agents. conditions such as duodenal ulcers are reported to be positive for H. pylori infection.11
PERFORMANCE CHARACTERISTICS Innovacon, Inc.
MATERIALS MDSS GmbH
Clinical Sensitivity, Specificity and Accuracy 9975 Summers Ridge Road
Materials Provided Manufacturer San Diego, CA 92121, USA Schiffgraben 41
The H. pylori Rapid Test Device (Whole Blood/Serum/Plasma) has been evaluated with specimens 30175 Hannover, Germany
• Test devices • Droppers • Buffer obtained from a population of symptomatic and asymptomatic individuals who presented for
• Package insert endoscopic examination. Culture and/or Histology of biopsy specimens served as the reference method.