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Rapid Chromatographic Immunoassay for SARS-CoV-2 and Influenza A B Antigens in Swab infectious disease testing

Basic Information
Brand Name: ALLTEST
Model Number: ISIC-502
Minimum Order Quantity: N/A
Price: negotiation
Packaging Details: 0.5mg/tube 1mg/tube, 2mg/tube、5mg/tube、10mg/tube、20mg/tube、30mg/tube
Delivery Time: 5-10 days
Payment Terms: Ex works
Supply Ability: 2000mg/month
Sample Type: Human Nasal Or Nasopharyngeal Swab. Formot: Cassette
Storage: 2-30°C Cut Off: See Insert
Shelf Time: 24months Test Principle: Chromatographic Immunoassay
Highlight:

recombinant antigen

,

protein antigen

SARS-CoV-2 and Influenza A+B Antigen Rapid Test is a rapid chromatographic
immunoassay for the qualitative detection of SARS-CoV-2 Nucleocapsid protein,
Influenza A and Influenza B nucleoproteins present in human nasal or
nasopharyngeal swab.
For professional in vitro diagnostic use only.
【INTENDED USE】
The SARS-CoV-2 and Influenza A+B Antigen Combo Rapid Test (Swab) is a
rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2
Nucleocapsid protein, Influenza A and Influenza B virus antigens in nasal or
nasopharyngeal swab specimens from individuals with suspected SARS-CoV-2/
Influenza infection in conjunction with clinical presentation and the results of other
laboratory tests.
Results are for the detection of SARS-CoV-2 Nucleocapsid protein and Influenza
A+B Antigens. An antigen is generally detectable in upper respiratory specimens
during the acute phase of infection. Positive results indicate the presence of viral
antigens, but clinical correlation with patient history and other diagnostic
information is necessary to determine infection status. Positive results do not rule
out bacterial infection or co-infection with other viruses. The agent detected may
not be the definite cause of disease.
Negative results do not preclude SARS-CoV-2/Influenza A+B infection and
should not be used as the sole basis for treatment or patient management
decisions. Negative results should be treated as presumptive and confirmed with
a molecular assay, if necessary for patient management. Negative results should
be considered in the context of a patient’s recent exposures, history and the
presence of clinical signs and symptoms consistent with SARS-CoV-2/Influenza
A+B.
【SUMMARY】
The novel coronaviruses belong to the β genus. COVID-19 is an acute respiratory
infectious disease. People are generally susceptible. Currently, the patients
infected by the novel coronavirus are the main source of infection; asymptomatic
infected people can also be an infectious source. Based on the current
epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7
days. The main manifestations include fever, fatigue and dry cough. Nasal
congestion, runny nose, sore throat, myalgia and diarrhea are found in a few
cases.
Influenza (commonly known as ‘flu’) is a highly contagious, acute viral infection of
the respiratory tract. It is a communicable disease easily transmitted through the
coughing and sneezing of aerosolized droplets containing live virus.1 Influenza
outbreaks occur each year during the fall and winter months. Type A viruses are
typically more prevalent than type B viruses and are associated with most serious
influenza epidemics, while type B infections are usually milder.
The gold standard of laboratory diagnosis is 14-day cell culture with one of a
variety of cell lines that can support the growth of influenza virus.2 Cell culture has
limited clinical utility, as results are obtained too late in the clinical course for
effective patient intervention. Reverse Transcriptase Polymerase Chain Reaction
(RT-PCR) is a newer method that is generally more sensitive than culture with
improved detection rates over culture of 2-23%.3 However, RT-PCR is expensive,
complex and must be performed in specialized laboratories.
【PRINCIPLE 】
The SARS-CoV-2 and Influenza A+B Antigen Combo Rapid Test (Swab) is a
qualitative membrane-based immunoassay for the detection of SARS-CoV-2
Nucleocapsid protein, Influenza A and Influenza B nucleoproteins in human nasal
or nasopharyngeal specimen. Antibody specific to the SARS-CoV-2, Influenza A
and Influenza B is separately coated in test line regions of the test. During testing,
the extracted specimen reacts with the antibody to SARS-CoV-2, Influenza A
and/or Influenza B that are coated onto particles. The mixture migrates up the
membrane to react with the antibody to SARS-CoV-2, Influenza A and/or
Influenza B on the membrane and generate one, two or three colored lines in the
test regions. The presence of this colored line in one or two or three of the test
regions indicates a positive result. To serve as a procedural control, a colored line
will always appear in the control region if the test has performed properly.
【REAGENTS】
The test contains anti-SARS-CoV-2, anti-Influenza A and anti-Influenza B as the
capture reagent, anti-SARS-CoV-2, anti-Influenza A and anti-Influenza B as the
detection reagent.
【PRECAUTIONS】
1. This package insert must be read completely before performing the test.
Failure to follow directions in package insert may yield inaccurate test results.
2. For professional in vitro diagnostic use only. Do not use after expiration date.
3. Do not eat, drink or smoke in the area where the specimens or kits are
handled.
4. Do not use test if pouch is damaged.
5. Handle all specimens as if they contain infectious agents. Observe
established precautions against microbiological hazards throughout in the
collection, handling, storage, and disposal of patient samples and used kit
contents.
6. Wear protective clothing such as laboratory coats, disposable gloves and eye
protection when specimens are assayed.
7. Viral Transport Media (VTM) may affect the test result, do not store
specimens in viral transport media; extracted specimens for PCR tests cannot
be used for the test.
8. Wash hands thoroughly after handling.
9. Please ensure that an appropriate amount of samples are used for testing.
Too much or too little sample size may lead to deviation of results.
10.The used test should be discarded according to local regulations.
11.Humidity and temperature may adversely affect results.
【STORAGE AND STABILITY】
Store as packaged in the sealed pouch either at room temperature or refrigerated
(2-30°C). The test is stable through the expiration date printed on the sealed
pouch. The test must remain in the sealed pouch until use. DO NOT FREEZE. Do
not use after the expiration date.
【MATERIALS】
Materials provided
• Test cassettes
• Sterile swabs
• Package insert
• Extraction buffer
• Extraction tubes and tips (Optional)
• Workstation
• Procedure card
Materials required but not provided
• Timer
【SPECIMEN COLLECTION, TRANSPORT AND STORAGE】
Nasal Swab Specimen Collection
1. Insert a sterilized swab less than one inch (about 2 cm) into a nostril (until
resistance is met at the turbinates).
2. Rotate the swab 5-10 times against the nasal wall. Using the same swab
repeat the collection procedure with the second nostril.
3. Withdraw the sterile swab; avoid excess volume and high-viscous nasal
discharge.
Nasopharyngeal swab Specimen Collection
1. Insert a sterile swab into the nostril of the patient, reaching the surface of the
posterior nasopharynx.
2. Swab over the surface of the posterior nasopharynx.
3. Withdraw the sterile swab from the nasal cavity.
Caution: If the swab stick breaks during specimen collection, repeat specimen
collection with a new swab.
Specimen transport and storage
Specimens should be tested as soon as possible after collection.
If swabs are not been processed immediately, it is highly recommended the swab
sample is placed into a dry, sterile, and tightly sealed plastic tube for storage. The
swab specimen in dry and sterile condition is stable for up to 24 hours at 2-8°C.
【SPECIMEN PREPARATION】
Only the extraction buffer and tubes provided in the kit is to be used for swab
specimen preparation. Please refer to the Procedure Card for detailed information
of Specimen Extraction.
1. Place the swab specimen in the Extraction tube with Extraction Buffer. Rotate
the swab for approximately 10 seconds while pressing the head against the
inside of the tube to release the antigen in the swab.
2. Remove the swab while squeezing the swab head against the inside of the
Extraction tube as you remove it to expel as much liquid as possible from the
swab. Discard the swab in accordance with your biohazard waste disposal
protocol.
*NOTE: The storage of the specimen after extraction is stable for 2 hours at room
temperature or 24 hours at 2-8°C.
【DIRECTIONS FOR USE】
Allow the test, specimen swab, buffer and/or controls to reach room
temperature (15-30°C) prior to testing.
1. Remove the test cassette from the sealed foil pouch and use it within one hour.
Best results will be obtained if the test is performed immediately after opening
the foil pouch.
2. Invert the specimen extraction tube and add 3 drops of extracted specimen
(approx.75-100 μL) to the specimen well (S) and then start the timer.
3. Wait for the colored line(s) to appear. Read the result at 15 minutes. Do not
interpret the result after 20 minutes.
 
Rapid Chromatographic Immunoassay for SARS-CoV-2 and Influenza A B Antigens in Swab infectious disease testing 0

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