Influenza A+B Antigen Rapid Test Kit Later Flow Assay Diagnostic Rapid Test Kit
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Detailed Product Description
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Influenza A+B Antigen Rapid Test Kit (Later Flow Assay) Diagnostic Test Kit
【INTENDED USE】 This product is used for in vitro qualitative detection of
influenza A and influenza B virus protein antigens in human swab
test samples. The InfluenzaA+B antigen combined rapid test kit is
designed to detect and identify influenza A and influenza B virus
nucleoprotein antigens. Antigens can generally be detected in
nasopharyngeal specimens during the acute infection stage. A positive result indicates the presence of viral antigens, but the
clinical correlation with the patient’s medical history and other
diagnostic information is necessary to determine the infection
status. A positive result does not exclude bacterial infection or
co-infection with other viruses. A negative result does not exclude influenza A or influenza B
infection, and should not be used as the sole basis for treatment
or patient management decisions, including infection control
decisions. Negative results must be combined with clinical
observation, patient history and epidemiological information, and
confirmed by molecular diagnostic analysis, and used for patient
management when necessary. The InfluenzaA+B antigen combined rapid
test kit is only for testing in medical institution. This product
is for professional used only. 【INTRODUCTION】 Influenza is a contagious respiratory disease caused by influenza
viruses. It can cause mild to severe diseases. The severe
consequences of influenza infection can lead to hospitalization or
death. Some people, such as the elderly, young children, and people
with certain health conditions, are prone to severe flu
complications. There are two main types of influenza viruses: type
A and type B. The influenza A and B (human influenza viruses) that
are usually spread among people are the cause of seasonal influenza
epidemics every year. 【PRINCIPLE】 The rapid test of influenza A+B is a lateral flow chromatography
detection method based on the principle of double antibody sandwich
technology. The anti-influenza A and influenza B monoclonal
antibodies combined with colloidal gold gold particles are used as
the label, and gold is sprayed on the binding pad. During the test,
the antigen and labeled antibody complexes are formed and migrated
on the membrane by capillary action. If the specimen contains
influenza A antigen, the complex will be captured by the pre-coated
influenza A monoclonal antibody, forming a visible colored line in
area A of the result window. If the specimen contains influenza B
antigen, the complex will be captured by the precoated influenza B
monoclonal antibody, forming a visible color line in the B area of
the result window. The control line (C) is used for process control
and should always appear if the test process is performed properly.
【CONTENTS】 Reagent cassette: The test kit includes the flu A+B test strip,
which are fixed in a plastic device; Swab (customized according to customer needs); Extraction tube and Buffer; Note: The components in the kits of different batch numbers cannot
be used interchangeably. Equipment and materials required for testing but not provided:
timer, gloves, goggles. 【STORAGE AND STABILITY】 Store at 2～30℃. Freezing is prohibited. Shelf life: 18 months when package is not open. The reagent should be used as soon as possible within 1 hour after
the aluminum foil bag is opened. Long-term exposure to the hot and
humid environment will cause the product to deteriorate. It is
recommended that the product be used immediately when the ambient
temperature is higher than 30℃ or high humidity. See the label for
the production date and expiration date. 【SAMPLE REQUIREMENT】 Specimens obtained early in the onset of symptoms will contain the
highest virus titer; Compared with RT-PCR testing, specimens obtained 5 days after the
onset of symptoms are more likely to produce Positive results;
Insufficient specimen collection, improper specimen handling and/or
transportation may produce false negative results; Do not return
the nasal swab to the original swab packaging; Freshly collected specimens should be processed as soon as
possible, but no later than 1 hour after specimen collection; The collected specimens can be stored at 2-8°C for no more than 24
hours; Store at -70℃ for a long time, but avoid repeated freeze-thaw
cycles; Improper sample handling, storage and transportation
methods may produce false negative results. 【PRECAUTIONS】 1) This product is disposable, please use it within the validity
period. 2) Do not use the aluminum foil bag if it is found to be damaged.
Please use it as soon as possible after opening the aluminum foil
bag. 3) All testing work must comply with the provisions of the
Biosafety Code and strictly prevent cross-infection. 4) All samples and used articles should be treated as potential
sources of infection. 5) It is recommended to use fresh samples, and never freeze-thaw
samples repeatedly. 6) Compared with adults, children are more likely to spread the
virus in a wider range and last longer. Therefore, the sensitivity
of children's detection may be higher than that of adults. 7) For the detection reagent of influenza A virus or each subtype,
when the antibody used is monoclonal, the slight change of epitope
caused by small mutation of nucleotide sequence may lead to false
negative result or decrease of analytical sensitivity of reagent. 8) When adding samples, add them vertically one by one to each
sample hole to avoid insufficient sample volume due to bubbles,
which will affect the interpretation of the product. 【OPERATION PROCEDURE】 SAMPLE COLLECTION This product can be equipped with disposable sampling swabs,
sampling is as follows: Nasal Sampling: Gently insert the swab head into the nasal cavity
and scrape the cavity wall. Immerse the swab head into sample solution and discard the tail of
swab. DETECTION 1. Insert the tip onto tube membrane, take out the tip after
membrane’s puncture. 2. Collect the swab sample according to above instruction. 3. Roll the swab at least 6 times while pressing the head against
the bottom and side of the extraction tube. Leave the swab into the extraction tube for 1 minute. Squeeze the tube by fingers from outside of the tube to immerse the
swab. Remove the swab. The extracted solution will be used as test sample. 4. Put the tip onto the tube, and take out its cap. 5. Add 2 drops of the mixed sample to each sample wells of the
cassette and read the results in 15 minutes. 【INTERPRETATION OF RESULTS】 FluA Positive: One colored line appears at the control region (C), another colored
line appears at the A test region, irregardless of the intensity of
the test line. Flu B Positive: One colored line appears at the control region (C), another colored
line appears at the B test region, irregardless of the intensity of
the test line. Flu A & B Positive: One colored line appears at the control region (C), and both the A
and B lines appear at the test region, irregardless of the
intensity of the test line. Negative: One colored line appears at the control region (C), and no lines
appear a the test region. Invalid: If the control line (C) is not visible within the result window
after performing the test, the result is considered invalid. Some
causes of invalid results are because of not following the
directions correctly or the test may have deteriorated beyond the
expiration date. It is recommended that the specimen be re-tested
using a new test. For further operation or performance details, please refer to final instruction manual.
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| Product Tags: Later Flow Assay Rapid Test Kit Influenza A+B Antigen Rapid Test Kit Diagnostic Rapid Test Kit |
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