Product Overview

H.pylori Antibody Test Device (Whole Blood/Serum/Plasma), is a rapid chromatographic immunoassay. It is designed for the qualitative detection of antibodies to Helicobacter pylori (H. pylori) in whole blood, serum, or plasma samples, serving as an auxiliary tool to aid in the diagnosis of H. pylori infection.

Disease Background

Helicobacter pylori (H. pylori) is a bacterium infecting the gastric mucosa, linked to chronic gastritis, peptic ulcers, and gastric cancer. Over 50% of the global population is infected, though many remain asymptomatic. Early detection is critical to prevent disease progression and complications.

Product Specification

Intended use	Detection of H.pylori Antibody
Storage	4-30°C
Shelf Life	24 Months
Sensitivity	97.6%
Specificity	98.7%
Accuracy	98.3%

Ordering Information

Product Name	Catalog No.	Specimen	Format	Certification
H.pylori Antibody Test	HPAb-3011	Serum/Plasma	Strip	CE
	HPAb-3012	Serum/Plasma	Cassette	CE
	HPAb-4011	Whole Blood/Serum/Plasma	Strip	CE
	HPAb-4012	Whole Blood/Serum/Plasma	Cassette	CE

Product Advantages

Rapid & Efficient: Results in 10 minutes, enabling timely clinical decisions.

High Accuracy: Clinically validated with 97.6% sensitivity, 98.7% specificity, and 98.3% overall accuracy (vs. biopsy).

Versatile Sample Compatibility: Works with whole blood, serum, or plasma.

Easy to Use: Simplified workflow for professional in vitro diagnostics.

Stable Storage: Reagent kits stored at 4–30°C (do not freeze); serum/plasma samples stored at 2–8°C for up to 7 days.

Operation Steps & Interpretation

Steps:

1.Equilibrate the device, specimen, and controls to 15–30°C.
2.Add 25µL of specimen to the sample well using the dropper.
3.Immediately add 40µL of buffer.
4.Read results at 10 minutes.

Interpretation:

product-780-249

Positive: Two red lines (Control [C] + Test [T]).
Negative: One red line (Control [C] only).
Invalid: No line in Control [C] – repeat test.

Note: Any pink/red line in Test [T] is considered positive.

FAQ

Q: What is the intended use of this test device?

A: It is a rapid chromatographic immunoassay for the qualitative detection of antibodies to H. pylori in whole blood, serum, or plasma, used to aid in the diagnosis of H. pylori infection. It is for professional in vitro diagnostic use only.

Q: What storage conditions are required for the test kit?

A: The kit can be stored at room temperature or refrigerated (4 - 30°C). Do not freeze the test device. The test device must remain in the sealed pouch until use to ensure stability.

Q: What types of specimens are acceptable, and how should they be handled?

A: Whole blood, serum, or plasma specimens are acceptable. Separate serum or plasma from blood as soon as possible to avoid haemolysis; only clear, non - haemolysed specimens can be used. Test immediately after collection. Serum or plasma can be stored at 2 - 8°C for up to 7 days, or below - 20°C for long - term storage. Frozen specimens must be completely thawed and mixed well before testing, and should not be frozen and thawed repeatedly. Frozen whole blood cannot be used. When shipping specimens, comply with federal, state, or local regulations for the transportation of etiologic agents.

Q: Can a negative test result completely rule out H. pylori infection?

A: No. This test only indicates the presence of H. pylori antibodies in the specimen and should not be used as the sole criteria for diagnosing H. pylori infection. If the test result is negative but clinical symptoms persist, additional testing using other clinical methods is recommended, as a negative result does not preclude the possibility of H. pylori infection at any time.

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