ISO 13485 H-Pylori Antigen Diagnostic Test Kit
China ISO 13485 H-Pylori Antigen Diagnostic Test Kit, Find details about China H. Pylori Test Kit, H. Pylori Stool Antigen from ISO 13485 H-Pylori Antigen Diagnostic Test Kit
Basic Info.
Model NO.
HP01
Format
Strip, Cassette
Specimen
Whole Blood/Serum/Plasma/Feces
Size
2.5mm,3.0mm, 4.0mm
Transport Package
1PCS/Foil Pouch
Specification
Strip/Cassette
Origin
Rugao, Nantong, Jiangsu, China
HS Code
3822001000
Model NO.
HP01
Format
Strip, Cassette
Specimen
Whole Blood/Serum/Plasma/Feces
Size
2.5mm,3.0mm, 4.0mm
Transport Package
1PCS/Foil Pouch
Specification
Strip/Cassette
Origin
Rugao, Nantong, Jiangsu, China
HS Code
3822001000
Product Desciption
High quality; Mutual-benefit price; Fast delivery; Best service
Product Description
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********* H.pylori Ab (Helicobacter pylori)test kit *********
Format | strip, cassette |
Specimen | Whole blood/serum/plasma/Feces |
Accuracy | Over 99% |
Read time | 10-15mins |
Expiry date | 24-36months |
Certificate | CE, FSC,ISO13485 |
Specification
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********* H.pylori Ab (Helicobacter pylori) test kit *********
Product Principle of H.pylori Ab test kit
The infection of Helicobacter pylori (H. pylori) is associated with a variety of gastro-intestinal diseases, such as stomach
ulcers, chronic active gastritis and gastrointestinal adenocarcinoma.
Antibodies to H. pylori are developed in individuals infected with H. pylori as a serological response.
Detecting specific antibodies to H. pylori can be used as a qualitative assay in the diagnosis of H. pylori infection, either
as an adjunct to endoscopy or as an alternative measure in symptomatic patients.
The H. Pylori Rapid Test is a chromatographic immunoassay (CIA) for the rapid determination of antibodies to H. pylori in
serum/plasma/whole blood specimens.
The test is to be used as an aid in the diagnosis of infection due to H. pylori.
Product type | strip, cassette |
Usual size | Strip: 2.5mm or 3.0mm Cassette: 3.0 or 4.0mm |
Specimen | Whole blood, serum/plasma |
Application period | Primary infection period or with symptoms |
| Type 1. H. pylori Ab test Strip Size: | 2.5mm 3.0mm |
| Type 2. H. pylori Ab test Cassette Size: | 3.0mm 4.0mm |
| Type 3. H. pylori Ag test cassette Size: | 3.0mm, 4.0mm |
| Storage | Indoor temperature of 2-30 degrees |
| Advantage | easy to use, fast to read result, accuracy and stable application, private usage |
Product Paramenters
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Example of statistical results of reagent of 240 samples
Reagent | Control reagent kit Positive Negative | Total | Specificity: Sp=100% False positive rate =0% False negative rate =0% Total accordance rate = 100% | |
Positive | 100 | 0 | 100 | |
Negative | 0 | 140 | 140 | |
Total | 100 | 140 | 240 | |
REAGENT PREPARATION AND STORAGE
Store test device unopened at 2°C-30°C. If stored at 2°C-8°C, ensure that the test device is brought to room
temperature before opening. Do not freeze the kit or expose the kit over 30°C.
Specimen of H. pylori Ab test Collection and Handling
For whole blood:
Collect whole blood into a collection tube by venipuncture. If specimens are not immediately tested, they should be
refrigerated at 2-80C. Freezing is recommended if the storage periods are more than 3 days. They should be brought to
room temperature before testing. Using the specimen after long-term storage of more than three days can cause
non-specific reaction. When stored at 2-8 0C, the whole blood sample should be used within three days.
For serum/plasma:
Blood should be collected aseptically into a clean tube without anticoagulants. Separate the serum or plasma from blood
as soon as possible to avoid hemolysis. Use clear non-hemolyzed specimens when possible.
Procedure of H. pylori Ab test kit
> Step 1: When you are ready to begin testing, open the sealed pouch by tearing along the notch. Remove the test
from the pouch.
> Step 2: For Strip Test:
Immerse the strip into the container wtih the arrow end pointing towards the container.
Do not immerse past the MAX(maximum) line.
Take the strip out after 8-10 seconds and lay the strip flat on a clean, dry, nonabsorbent surface
(e.g., mouth of the serum container).
For Cassette Test:
Drip 2 or 3 drops of specimen into the sample window.
>Step 3 : Wait 10-15 minutes and read result. Do not read results after 30 15 minutes.
How to read the result of H. pylori test kit
>1. Negative: Only one pink band appears on test region.
>2. Positive: Two pink bands appear on test region.
>3. Invalid: If without colored band appears on test region, this is an indication of a possible error in
performing the test.
The test should be repeated using a new device.
WARNINGS AND PRECAUTIONS FOR Using H. pylori Ab test kit
≡1. Must use fresh specimen and avoid repetitive freezing, the result will be invalid
≡2. Use it before expiry date.
≡3. The package of kit should not be opened until it reaches the room temperature if it taken out from the refrigerator.
≡4. Old Serum can not be used. If the serum is thick, it can be used only after being separated.
More rapid test products for your reference.
Store test device unopened at 2°C-30°C. If stored at 2°C-8°C, ensure that the test device is brought to room
temperature before opening. Do not freeze the kit or expose the kit over 30°C.
Specimen of H. pylori Ab test Collection and Handling
For whole blood:
Collect whole blood into a collection tube by venipuncture. If specimens are not immediately tested, they should be
refrigerated at 2-80C. Freezing is recommended if the storage periods are more than 3 days. They should be brought to
room temperature before testing. Using the specimen after long-term storage of more than three days can cause
non-specific reaction. When stored at 2-8 0C, the whole blood sample should be used within three days.
For serum/plasma:
Blood should be collected aseptically into a clean tube without anticoagulants. Separate the serum or plasma from blood
as soon as possible to avoid hemolysis. Use clear non-hemolyzed specimens when possible.
Procedure of H. pylori Ab test kit
> Step 1: When you are ready to begin testing, open the sealed pouch by tearing along the notch. Remove the test
from the pouch.
> Step 2: For Strip Test:
Immerse the strip into the container wtih the arrow end pointing towards the container.
Do not immerse past the MAX(maximum) line.
Take the strip out after 8-10 seconds and lay the strip flat on a clean, dry, nonabsorbent surface
(e.g., mouth of the serum container).
For Cassette Test:
Drip 2 or 3 drops of specimen into the sample window.
>Step 3 : Wait 10-15 minutes and read result. Do not read results after 30 15 minutes.
How to read the result of H. pylori test kit
>1. Negative: Only one pink band appears on test region.
>2. Positive: Two pink bands appear on test region.
>3. Invalid: If without colored band appears on test region, this is an indication of a possible error in
performing the test.
The test should be repeated using a new device.
 |  |
WARNINGS AND PRECAUTIONS FOR Using H. pylori Ab test kit
≡1. Must use fresh specimen and avoid repetitive freezing, the result will be invalid
≡2. Use it before expiry date.
≡3. The package of kit should not be opened until it reaches the room temperature if it taken out from the refrigerator.
≡4. Old Serum can not be used. If the serum is thick, it can be used only after being separated.
More rapid test products for your reference.
Packing & Delivery
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Package: go as normal package or as per clients needs.
Out carton size:63*26*49CM; Gross weight: 13KG
Out carton size:63*26*49CM; Gross weight: 13KG
Shipping: by sea or by air.
Company Profile
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Our Advantages
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FAQ
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1. Q: Sample available?A: Reasonable quantity free samples will be available to sent for quality evaluation.
2. Q: Do you have minimum order quantity requirements?A: Yes, but quantity can be negotiated.
3. Q: Can we visit your factory?A: sure, welcome you to visit our factory any time.
4. Q: How to ensure the cargo quality?A: A professional QC team will control the goods quality during all the mass production or a third party inspection service
could be arranged at your expense if you want. We will supply bulk sample for evaluation before shipping.
6. Q: Which certificates do you have?A: We already got CE 0123, ISO13485 and ISO 9001 certificate.
7. Q: How to pay?A: Payment can be made by paypal, western union, bank transfer, etc.
2. Q: Do you have minimum order quantity requirements?A: Yes, but quantity can be negotiated.
3. Q: Can we visit your factory?A: sure, welcome you to visit our factory any time.
4. Q: How to ensure the cargo quality?A: A professional QC team will control the goods quality during all the mass production or a third party inspection service
could be arranged at your expense if you want. We will supply bulk sample for evaluation before shipping.
6. Q: Which certificates do you have?A: We already got CE 0123, ISO13485 and ISO 9001 certificate.
7. Q: How to pay?A: Payment can be made by paypal, western union, bank transfer, etc.
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