ACCU-TELL® H. pylori IgG/IgM/IgA Cassette/Strip (Whole Blood/Serum/Plasma)

CATALOG

KEY POINTS:

Reading time: within 15-20 minutes;

Specimen volume: Serum/Plasma: 25μl; Whole Blood: 50μl; 
Detection for: Helicobacter pylori (H. pylori) antibodies (IgG, IgM, IgA) in Whole Blood/Serum/Plasma;

Relative Sensitivity: 99.38% (95%CI*: 97.78%-99.83%)

Relative Specificity: 99.17% (95%CI*: 98.21%-99.62%)

Accuracy: 99.24% (95%CI*: 98.5%-99.61%)

*95% Confidence Intervals

INTRODUCTION

Helicobacter Pylori (HP) grows in gastric mucus deep layer, surface of gastric mucosa, and mostly in gastric antrum, gastric pit, epithelial deep fold and gland cavity. There will be a short-term acute gastritis symptom with epigastric pain, nausea, emesis and flatulence after helicobacter pylori enter the stomach. The most common infection is chronic gastric inflammation with no obvious symptoms, which will cause duodenal ulcer and gastric ulcer. HP is a pathogenic factor of stomach cancer, for causing Induction of bacterial proliferation, Changes of gastric mucosa, decrease of hydrochloric acid in gastric juice. Over 90% of duodenal ulcer is found with HP, over 70% of gastric ulcer is found with HP and over 60% of chronic gastritis is associated with HP.

INTENDED USE

ACCU-TELL^® H. pylori (IgG, IgM, IgA) Cassette/Strip (Whole Blood/Serum/Plasma) is used to detect the HP antibodies (IgG,IgM and IgA) in human Whole Blood/Serum/Plasma qualitatively.

TEST PROCEDURE

1. Instructions must be read entirely before taking the test. Allow the test device controls to equilibrate to room temperature for 30 minutes (20°C-30°C) prior to testing. Do not open the inner packaging until ready, it must be used in one hour if opened (Humidity: ≤60%, Temp: 20°C-30°C). Please use immediately when the humidity >60%.

2. Test Procedure

For test cassette:

(1) Remove the test cassette from the sealed pouch, place it on a clean and level surface with the sample well up.

(2) Serum/Plasma: Drop 1 full drop (25μl) of serum/plasma vertically into the sample well of cassette. Add about 2 full drops (80μl-100μl) of sample buffer into the sample well of cassette.

Whole blood: Drop 2 full drops (50μl) of whole blood vertically into the sample well of cassette. Add about 2 full drops (80μl-100μl) of sample buffer into the sample well of cassette.

(3) Observe the test results immediately within 15-20 minutes, the result is invalid over 20 minutes.

 For test strip:

(1). Take off the outer packing, put the strip onto the desk with the sample adding area of the strip.

(2). Serum/Plasma: Drop 1 full drop (25μl) of serum/plasma vertically onto the sample adding area of the Strip. Add about 2 full drops (80μl-100μl) of sample buffer onto the sample adding area of the Strip.

Whole blood: Drop 2 full drops (50μl) of whole blood vertically onto the sample adding area of the Strip. Add about 2 full drops (80μl-100μl) of sample buffer onto the sample adding area of the Strip.

(3). Observe the test results immediately within 15-20 minutes, the result is invalid over 20 minutes.

PERFORMANCE CHARACTERISTICS

1. Using internal quality control samples

Negative specificity: The results should all be negative when detecting 10 kits of HP negative quality control samples.

Positive specificity: The results should all be positive when detecting 10 kits of HP positive quality control samples.

Limit of detection: Positive Detection of Series of Diluted Positive References should not be less than 1:8.

Repeatability: The results should be consistent and the coloration degree should be consistent when detecting the precision control samples by 10 kits of the same batch.

2. Analytical sensitivity:

Cross reaction: The addition of hepatitis B virus, hepatitis A virus, hepatitis C virus, syphilis, human immunodeficiency virus samples showed no cross-reactivity.

Interference factor: 1000 mol/L bilirubin, 5.65mmol/L triglyceride, 6.5g/L hemoglobin has no effect on the detection result. The reagent is not affected by the rheumatoid factor.

Clinical Performance:

A clinical evaluation was conducted on 1050 samples (including 324 positive samples and 726 negative samples) comparing the results obtained using ACCU-TELL®H. pylori IgG/IgM/IgA Cassette (Whole Blood/Serum/Plasma) and other commercially available Diagnostic Kit for Helicobacter pylori Antigen (Colloidal Gold). The results are as follows:

Relative Sensitivity: 322/ (322+2)*100%=99.38%(95%Cl: 97.78%-99.83%

Relative Specificity: 720/ (720+6)*100%=99.17%(95%Cl: 98.21%-99.62%)

Accuracy: (322+720)/(324+726)*100%=99.24%(95%Cl: 98.50%-99.61%)

LIMITATIONS

1. This reagent is designed for the qualitative screening test.  Concentration of HP cannot be determined by this qualitative test.

2. The results of the reagent are only for clinical reference, which is not the only basis for clinical diagnosis and treatment. A confirmed diagnosis and treatment should only be made by a physician after all clinical and laboratory findings have been evaluated.

3. Positive results indicating the presence of gastric helicobacterpylori antibody, but it can't determine whether gastric helicobacter pylori has led to the gastritis, gastric ulcer or the duodenal bulb ulcer. A confirmed diagnosis of gastritis, gastric ulcer or the duodenal bulb ulcer must be made with the clinical symptoms and other diagnostic techniques.

4. Negative result does not completely ruled out gastric helicobacter pylori infection, it only indicates that the specific antibodies of the stomach helicobacter pylori does not exist or the concentration is below detection limit. When HP infection is still suspected, a bacterial culture or histological analysis diagnosis is suggested.

Note: The above information is for reference use only. Please refer to the product insert provided with the products before use.