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Sekisui Diagnostics

Sekisui OSOM H. pylori Test – Rapid Antibody Test Kit with 25 Tests and Positive and Negative Controls

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Description

The Sekisui OSOM H. pylori Test detects H. pylori antibodies in serum, plasma or whole blood at the point of care. Results read in 10 minutes or less, so clinicians can discuss findings while the patient is still in the office.

  • Three Sample Types – Serum, plasma or whole blood all work with the same kit, which fits both office and laboratory workflows.
  • 10 Minute Results – A readable result in 10 minutes or less keeps the test inside a single patient visit.
  • Published Performance – The manufacturer reports 95.9 percent sensitivity versus biopsy and histology.
  • Matched Control Set – A bottled positive and negative control set is offered under the same product family for external QC.

About This Rapid H. pylori Antibody Test

Patients with dyspepsia and ulcer symptoms need an answer that does not wait on a send out laboratory, and this cassette gives offices a same visit screening step. It detects antibodies to Helicobacter pylori qualitatively, as an aid in the diagnosis of H. pylori infection.

The easy to read result window keeps interpretation simple for staff running the test between other duties. A matched control set with one positive and one negative bottle supports the external quality control checks that waived testing programs document.

Features and Benefits

Testing Workflow

  • Rapid Turnaround – Results in 10 minutes or less support test and treat decisions during the same appointment.
  • Simple Interpretation – The two line read is designed to be read at a glance without instrumentation.

Sample Flexibility

  • Serum, Plasma or Whole Blood – One kit covers fingerstick style whole blood draws and separated samples, so sites stock a single format.
  • Control Materials – The companion control set carries 1 mL positive and 1 mL negative bottles for documented QC runs.

Product Specifications

Product Details

  • Manufacturer: Sekisui Diagnostics
  • Test Type: Rapid qualitative antibody test
  • Target: H. pylori antibodies
  • Specimen: Serum, plasma or whole blood
  • Time to Result: 10 minutes or less
  • Sensitivity: 95.9 percent versus biopsy and histology, manufacturer stated
  • CPT Codes: 86318QW whole blood, 86677 serum or plasma

Configurations

  • Test Kit: 25 tests
  • Control Set: 1 positive and 1 negative 1 mL bottle

Browse related categories: diagnostic test kits and Sekisui Diagnostics products.

Why Choose This H. pylori Test for Office Testing

Office based testing programs need a screen that runs on the samples they already collect. This kit accepts serum, plasma or whole blood and reads inside 10 minutes, so one format covers the phlebotomy draw and the quick whole blood check alike.

  • Same Visit Answers – A 10 minute read lets the clinician act on the result before the patient leaves, which is the outcome office testing is bought for.
  • One Kit, Three Sample Types – Stocking one format for serum, plasma and whole blood cuts the shelf space and training burden of parallel kits.
  • Documented Performance – The manufacturer publishes 95.9 percent sensitivity against biopsy and histology, a concrete figure your medical director can review.
  • QC Ready – The matched bottled control set makes scheduled external QC runs straightforward to document.

Manuals and Troubleshooting Guides

Frequently Asked Questions

Which sample types can this test use?

The kit accepts serum, plasma or whole blood. Sites can run it on a separated sample or on whole blood collected during the visit.

How long does the test take?

Results read in 10 minutes or less after the sample is applied. Most offices document the result within the same appointment.

What does a positive result mean?

A positive result shows antibodies to H. pylori are present, which aids the clinician in diagnosing H. pylori infection. Treatment decisions stay with the ordering clinician.

What comes in the control set configuration?

The control set holds one 1 mL bottle of positive control and one 1 mL bottle of negative control. It is used for external quality control of the test kit.

How many tests are in one kit?

Each test kit carries 25 tests. The control set is a separate configuration under the same product listing.

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Warranty Information

This product may be covered under the manufacturer's original warranty. Please refer to the manufacturer's documentation or contact us for assistance.
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