Wholesale H-Pyhori Antibody Rapid Test Cassette treatment antigen test home use CIA ISO approved

Wholesale H-Pyhori Antibody Rapid Test Cassette treatment antigen test home use CIA ISO approved




This product is a serum / plasma detection method without any instruments and equipment. It uses the principle of immunochromatography to qualitatively detect the specific antibody of Helicobacter pylori in human serum and plasma. The auxiliary diagnosis of whether cases with gastric symptoms are infected with gastric Helicobacter pylori is only used for in vitro diagnosis.

[measurement principle]

H. The pylori detection kit uses highly specific antibody antigen reaction and immunochromatographic analysis technology to qualitatively detect whether there is anti Helicobacter pylori antibody in serum / plasma. The test paper contains mouse anti human antibody pre fixed in the test area (T) on the membrane and corresponding antibody in the quality control area (c). During the test, drop the serum / plasma sample into the sample end of the test paper or the sample adding hole (s) of the test paper, and the serum / plasma sample reacts with the H. pylori antigen combined with the pre coated latex particles. The mixture is then chromatographed upward under capillary effect. If it is positive, the latex will first bind to the anti Helicobacter pylori antibody in the sample during chromatography, and then the conjugate will be fixed on the membrane, mouse anti human antibody will bind, and a red band will appear in the test area (T). If negative, there will be no red band in the test area (T). Whether the anti Helicobacter pylori antibody is present in the blood sample or not, a red band will appear in the quality control area (c). The red band displayed in the quality control area (c) is the standard to judge whether there are enough samples and whether the chromatography process is normal, and also serves as the internal control standard of the reagent.

[package composition]

L H.pylori latex test paper (several copies)

L disposable plastic straw

L instruction manual (1 copy)

[equipment required for testing]

L timer

L disposable test tube

L centrifuge (for plasma only)

[specimen collection]

Serum or plasma shall be separated as soon as possible during sample collection to avoid hemolysis. Fresh samples should be used as much as possible during testing. If the specimen cannot be submitted for examination in time, it can be refrigerated at 2 ℃ - 8 ℃ for 3 days. Long term storage shall be frozen at - 20 ℃, and repeated freezing and thawing is prohibited

[operation steps]

Before the test, the user manual must be read completely, and the test paper and blood sample must be restored to room temperature (18 ℃ - 30 ℃) before use.

1. Take out the test paper from the original aluminum foil bag and use it as soon as possible within 1 hour.

2. Test strip: insert the test strip into the sample, do not exceed the max mark line, for no less than 10 seconds, or place the test strip on a clean and flat table, and vertically drop 3 drops (about 100ml) of serum / plasma without empty bubbles with a plastic straw into the sample adding hole (s) of the kit.

3. Wait for the purplish red strip to appear, and the test results shall be read in 15 minutes. It is invalid after 20 minutes.

[result judgment]

Positive (+): two red bands appear. One is in the test area (T) and the other is in the quality control area (c). The positive results showed that the specimen contained anti Helicobacter pylori antibody.

Negative (-): only one red band appears in the quality control area (c), and no purplish red band appears in the test area (T). The negative results showed that no anti Helicobacter pylori antibody was detected in the samples.

Invalid: no red band appears in the quality control area (c), indicating incorrect operation process or deterioration and damage of the kit. In this case, carefully read the instructions again and retest with a new kit. If the problem persists, stop using this batch number of products immediately and contact the local supplier.

Note: the purplish red bands in the test area (T) can show different shades of color

Color. However, within the specified observation time, regardless of the color of the ribbon, i.e

So that only very weak color bands should also be judged as positive results.

[sensitivity, specificity and accuracy]

H. pylori test kit was used to detect the serum and plasma samples of symptomatic and asymptomatic people collected by endoscopy, and biological methods (culture and / or histology) were used as reference detection. If the specimen is positive by culture or histology or both methods, it is determined as positive specimen. If it is negative by both methods, it is determined as negative specimen. The relative sensitivity is 94.2%, the relative specificity is 76.8%, and the accuracy is 86.2%

[cross reaction]

Campylobacter jejuni, fetal Campylobacter, Campylobacter coli and Escherichia coli all contain a certain amount of Helicobacter pylori antibody. No cross reaction was found after detection with these bacteria, indicating aconh The pylori detection kit is highly specific for the detection of human Helicobacter pylori antibody.

[restrictions on use]

1. H. pylori test kit is only used for in vitro diagnosis and only for detecting antibodies in serum or plasma samples.

2. H. pylori test kit only proves the presence of Helicobacter pylori antibody in the sample, which cannot be used as the only criterion for judging Helicobacter pylori infection.

3. The diagnosis result of H. pylori test kit is an auxiliary diagnosis of clinical detection.

4. If the test result is negative and the clinical symptoms still exist, further clinical testing should be done. Negative test results still can not rule out Helicobacter pylori infection.

[storage and stability]

The original packaging shall be stored at 2 ℃ - 30 ℃ in a cool, dark and dry place with a validity period of 24 months. Do not freeze or use after the expiration date.

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