Key Words: Newscen H. Pylori Antibody (HP) Rapid test
Sample type： Serum, Plasma or Whole Blood
Detection type： Qualitative
Method: Colloidal Gold Rapid Test
Certificate: ISO9001/ ISO13485/CE/NMPA
Format: Cassette, Strip, Uncut Sheet
Reading time :
Observe the result in 20 minutes
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(2) With the natural package
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Newscen H. Pylori Antibody (HP) Rapid Test is a chromatographic immunoassay (CIA) for the qualitative detection of Helicobacter pylori antibody in serum/plasma and whole blood. Detecting these specific antibodies to H. pylori can be used in the diagnosis of H. pylori infection. It may be used either as an adjunction to endoscopy or as an alternative measure in symptomatic patients. The test kit is used in clinical laboratories and other care sites by clinical professionals.
The NewScen H. pylori Rapid Test is a lateral flow, chromatographic immunoassay test. H. pylori recombinant antigens are precoated onto membrane as a capture reagent on the test band region. During the assay, the specimen is allowed to react with H. pylori antigens-gold conjugate. The mixture then moves laterally on the membrane chromatographically to the test region with immobilized antigens of H. pylori. If H. pylori antibodies are present in the specimen, two colored bands are formed on the test region. One colored band in the test region indicates a negative result. To serve as a procedural control, the red-colored band in the control region will always appear regardless of the presence of H. pylori antibodies.
H. pylori were mainly presented in the stomach and duodenum area, causing the chronic inflammation of gastric mucosa, gastro-duodenal ulcer or gastric cancer. Above 60% of patients with gastric and duodenal ulcers can be diagnosed with HP. Measures to detect HP mainly are gastroscope sampling test, urease test, direct bacteria examination. The test is to be used as an aid in the diagnosis of infection due to H. pylori.
Newscen H. Pylori Antibody (HP) Rapid Test Kits should be stored at a cool dark place at temperature 4-30°C and, the sealed pouch for the duration of the shelf life (24 months). Avoid heat and sunlight or cold storage to transport. Opened test kit shall be used in one hour after tearing the foil pouch.
4.Sample Collection And Test Preparation:
Peripheral blood (e.g. finger blood) or venous blood specimen are used. The fresh blood after collection should be used immediately.
1. Have a certified phlebotomist collect whole blood into a collection tube (containing EDTA or heparin, respectively) by venipuncture.
2. Separate the plasma by centrifugation.
3. Carefully withdraw the plasma for testing, or label and store sample in 7 days at 2-8°C. Plasma may be frozen at -20°C for up to 3 months. Avoid hemolysis or repeated freeze-thawing.
1. Have a certified phlebotomist collect whole blood into a collection tube (containing no anticoagulants) by venipuncture.
2. Allow the blood to clot.
3. Separate the serum by centrifugation.
4. Carefully withdraw the serum for testing or label and store sample in 7 days at 2-8°C. Serum may be frozen at -20°C for up to 3 months. Avoid hemolysis or repeated freeze-thawing.
Serum (plasma) samples need a sterile operation in collection and preservation. Bacteria-polluted samples cannot be used. Cloudy sample required filtration or centrifugation.
5.Procedure of NewScen HPAb Rapid Test Kit:
Serum or Plasma Sample:
Add 2-3 drops (100-150μL) serum or plasma into the sample well. Observe the result in 20 minutes.
Whole Blood Sample:
Add 2 drops (100～120μL) of whole blood into the sample well, after all, blood is completely absorbed, add 1 drop of whole blood diluent. Observe the result in 20 minutes.
6.1 Negative: Only one pink band appears in the control band region.
6.2 Positive: Two pink bands appear.
6.3 Invalid: If no band appears or only the test line appears, this indicates a possible error in performing the test. The test should be repeated using a new device.