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FluA High Sensitivity Colloidal Gold Infection Detection WWHS Rapid Test Kits By Immunochromatography

FluA High Sensitivity Colloidal Gold Infection Detection WWHS Rapid Test Kits By Immunochromatography

immunochromatography Rapid Test Kits

Colloidal Gold Rapid Test Kits

FluA FluB Rapid Test Kits

Place of Origin:

CN

Brand Name:

WWHS

Certification:

CE

Model Number:

FluA/B

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Product Details
Product Name:
FluA & FluB Rapid Test Kit
Pack Size:
20 Tests
Application In:
WWHS NIR-1000 Dry Fluoroimmunoassay Analyser
Format:
Cassette
Manufacturer:
WWHS Biotech INC
Advantage:
High Sensitivity, High Accuracy
Payment & Shipping Terms
Minimum Order Quantity
1000
Price
US 3.00 Kit
Packaging Details
Paper Box
Delivery Time
7 Days
Payment Terms
L/C, T/T, Western Union
Supply Ability
30000 Kits per Week
Product Description

【Product name】 FluA FluB.pdf

Influenza A / B(FluA / B)Virus Antigen Rapid Test Kit (Colloidal Gold)

 

【Package specification】

25 Tests/kit

 

【Inspection principle】

Double antibody sandwich method was used to detect influenza A and B virus antigens by immunochromatography. During detection, the treated extract is added to the sample adding hole of the test card. When the sample to be tested contains influenza A and (or) B virus antigen and the antigen concentration is higher than the minimum detection limit, influenza A and (or) B virus antigen first forms a reaction complex with the labeled antibody, and the reaction complex moves forward along the nitric acid fiber membrane under the action of chromatography, It is captured by the monoclonal antibody of influenza A virus nucleoprotein and / or influenza B virus nucleoprotein pre coated in the detection areas (2) and (or) (1) on the nitric acid fiber membrane, and a red reaction line is finally formed in the detection areas (2) and (or) (1). At this time, the result is positive; On the contrary, when the sample does not contain influenza A and B virus antigen or the antigen concentration is lower than the minimum detection limit, there is no red reaction line in the detection area, and the result is negative. No matter whether the sample contains influenza A or B virus antigen, a red reaction line will be formed in the quality control area (c). The red reaction line displayed in the quality control area (c) is not only the standard to judge whether the chromatographic process is normal, but also the internal control standard of the reagent.

 

【Components】

Name Quantity Component
Test cards 25

a) Monoclonal antibodies against influenza A virus nucleoprotein and influenza B virus nucleoprotein (fixed in the T region of nitrocellulose membrane);

b) Sheep anti mouse immunoglobulin G (IgG) polyclonal antibody (fixed in region C of nitrocellulose membrane);

c) Colloidal gold labeled monoclonal antibody against influenza A virus nucleoprotein and influenza B virus nucleoprotein (fixed on glass fiber);

d) Other test strip supports.

Sample diluent 25(400μL/tube) Phosphate buffer
Swabs 25 Flocking
 

The components in different batches of kits cannot be used interchangeably.

 

【Storage conditions and validity】

The kit should be stored at 4℃~30℃, out of direct sunlight. It is valid for 18 months. The test card should be used within 15 minutes after unsealing under the environment of 15℃~30℃ and 20% ~ 90% relative humidity.

The production date, batch number and expiration date are shown in the outer package of the product.

 

【Test procedure】

Please read the operating instructions carefully before testing. Please restore all tests to room temperature before the test. The test shall be carried out at room temperature.

1. Insert the swab after sampling into the sample buffer and rotate it close to the inner wall of the test tube for about 10 times to make the sample dissolve in the solution as much as possible.

 

2. Squeeze the cotton swab head of the swab along the inner wall of the extraction tube to keep the liquid in the tube as much as possible. Break the tail of the swab, cover the extraction tube cover, and break the upper part of the extraction tube after mixing.

 

 

3. Open it along the opening of the aluminum foil bag, take out the reagent card and place it flat.

4. Drop 80 µL (about 3-4 drops) of treated sample extract into the sampling hole of the test card or directly add 80 µL of treated virus culture medium.

 

5. Observe the displayed results within 15 ~ 20 minutes, and the results displayed after 30 minutes have no clinical significance.

 

【Limitations of methods】

1. This reagent is only used to detect respiratory secretions of nasopharyngeal swabs and oropharyngeal swabs.

2. The test card only provides qualitative detection for influenza A and B viruses in the sample. If you need to test the specific content of a certain index, please use relevant professional instruments.

3. The test results of this reagent are only for clinical reference and shall not be used as the only basis for clinical diagnosis and treatment. The clinical management of patients shall be comprehensively considered in combination with their symptoms / signs, medical history, other laboratory tests and treatment reactions.

4. Possibility analysis of false negative results

① Unreasonable sample collection, transportation and treatment, and low virus titer in the sample may lead to false negative results.

② Viral gene variation may lead to changes in antigenic determinants, resulting in false results.

③ The optimal sample type and the optimal sampling time (peak virus titer) after infection have not been verified. Therefore, collecting samples in multiple parts and times in the same patient may avoid false infection.

5. Cross reactivity:

(1) Influenza A virus and influenza B virus do not interact with each other.

(2) Influenza C virus, parainfluenza virus, adenovirus, respiratory syncytial virus, herpes simplex virus, epidemic virus, fan virus, respiratory Chlamydia, mycoplasma, Mycobacterium tuberculosis, pertussis, Candida albicans, diphtheria, Haemophilus influenzae, Legionella pneumoniae, Mycobacterium tuberculosis, Staphylococcus aureus, enterovirus 71 (EV71) bacteria Coronavirus, etc.

6. Interfering substances:

The common interfering substances in the sample, such as blood, mucin and pus, have no effect on the test results. Drugs used to treat or alleviate influenza symptoms, such as nasal corticosteroids, analgesics and antipyretics, decongestants, antitussive drugs, antihistamines and antiviral drugs, have no effect on the test results.

7. Hook effect:

When the concentration of influenza A virus in the sample is less than 5.1 ×106TCID50 / ml, there was no hook effect. When the concentration of influenza B virus is less than 5.6 ×106TCID50 / ml, there was no hook effect.

 

【Note】

1. This product is a disposable in vitro diagnostic reagent. Do not use expired products.

2. There is no color band on the quality control line and inspection line, indicating that there is an error and the detection should be retried.

3. Avoid the high temperature of the test environment. The test card stored at low temperature needs to be restored to room temperature and then opened to avoid moisture absorption.

4. It is recommended to use fresh samples instead of repeated freeze-thaw samples.

5. For sampling, please use the sub sample and sample extract provided by this test box. Do not mix different batches of test cards and sample buffer.

6. If the virus sampling solution is used to treat the sample, it can be detected directly without diluting the sample extraction solution.

7. For the detection of influenza A virus or subtypes, the small change of antigen epitope caused by small-scale mutation of nucleic acid sequence may lead to the reduction of clear results or the analytical sensitivity of reagents.

8. Pay attention to safety measures during operation, such as wearing protective clothing, gloves, etc. The used swabs, test cards and extraction tubes shall be decontaminated before being discarded. It is recommended to disinfect them with high-pressure steam.

FluA High Sensitivity Colloidal Gold Infection Detection WWHS Rapid Test Kits By Immunochromatography 0FluA High Sensitivity Colloidal Gold Infection Detection WWHS Rapid Test Kits By Immunochromatography 1

 

 

 

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