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BioSign® H. pylori

Biosign h pylori

Immunoassay for the Qualitative Detection of Anti-Helicobacter pylori Antibody
in Human Whole Blood, Serum or Plasma

  • Easy-to-read color
  • Built-in test control
  • Single reagent procedure provides results in 10 minutes
  • Fingerstick whole blood convenience
Time to Results 10-15 minutes
Specimen Types Whole blood, 25 µL
Serum, 10 µL
Plasma, 10 µL
Internal Control Yes
External Controls No
Storage 2-30°C (35-86°F)
  vs Biopsy/Histology vs Agglutination Test vs ELISA
Relative Sensitivity 95.9% 93.0% 92.9%
Relative Specificity 89.1% 93.4% 91.9%
Overall Accuracy 91.6% 93.2% 92.3%
Biosign hpylori procedure
  1. Remove a device from pouch and place on flat surface.
  2. For serum or plasma fill a capillary tube to the red line (10 µL). For whole blood fill a capillary tube to the black line (25 µL). Apply sample by lightly tapping the capillary on the pad of the UPPER AREA of the Sample well (S).
  3. Add 2 to 3 drops of Developer Solution onto the LOWER AREA of the Sample Well (S).
  4. Read result at 10 minutes. (Do not read after 15 minutes).
Product Kit Size Catalog Number CLIA Complexity
BioSign® H. pylori (whole blood; serum or plasma) 35 BSP-406-35 Waived (whole blood), Moderate (serum or plasma)
BioSign® H. pylori (whole blood; serum or plasma) 10 BSP-406-10 Waived (whole blood), Moderate (serum or plasma)