ICIC-525 COVID 19 Antigen Rapid Test Kit Influenza AB Rapid Test Vitro Diagnostic
Brand Name:Citest
Certification:CE
Model Number:ICIC-525
Minimum Order Quantity:N/A
Place of Origin:-
Price:negotiation
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Hangzhou Zhejiang
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170-422, Richards Street, Vancouver BC V6B 2Z4, CANADA
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Product Details
COVID-19 and Influenza A+B Antigen Combo Rapid Test, Covid-19 Combo Rapid Test kit
Application
COVID-19 and Influenza A+B Antigen Combo Rapid Test is a rapid
chromatographic immunoassay for the qualitative detection of
SARS-CoV-2 Nucleocapsid protein, Influenza A and Influenza B virus
antigens present in human nasopharynx. For professional in vitro
diagnostic use only.
| Principle | Chromatographic Immunoassay |
| Format | Cassette |
| Specimen | Nasopharyngeal Swab |
| Certificate | CE |
| Reading Time | 15 minutes |
| Pack | 20 T |
| Storage Temperature | 2-30°C |
| Shelf Life | 2 Years |
INTENDED USE
The COVID-19 and Influenza A+B Antigen Combo Rapid Test
(Nasopharyngeal Swab) is a rapid chromatographic immunoassay for
the qualitative detection of SARS-CoV-2 Nucleocapsid protein,
Influenza A and Influenza B virus antigens in 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 COVID-19/ Influenza A+B.
FEATURES.
Fast results
Easy visually interpretation
Simple operation, no equipment required
High accuracy
PRINCIPLE
The COVID-19 Antigen Rapid Test (Nasopharyngeal Swab) is a
qualitative membrane-based immunoassay for the detection of
SARS-CoV-2 Nucleocapsid protein in human nasopharyngeal swab
specimen. SARS-CoV-2 antibody is coated in test line region. During
testing, the specimen reacts with SARS-CoV-2 antibody-coated
particles in the test. The mixture then migrates upward on the
membrane by capillary action and reacts with the SARS-CoV-2
antibody in test line region. If the specimen contains SARS-CoV-2
Nucleocapsid protein, a colored line will appear in test line
region as a result of this.
If the specimen does not contain antigens to SARS-CoV-2, no colored
line will appear in the test line region, indicating a negative
result. To serve as a procedural control, a colored line will
always appear in the control line region, indicating that the
proper volume of specimen has been added and membrane wicking has
occurred.
The Influenza A+B Rapid Test (Nasopharyngeal Swab) is a
qualitative, lateral flow immunoassay for the detection of
Influenza A and Influenza B nucleoproteins in human nasopharyngeal
swab specimen. In this test, antibody specific to the Influenza A
and Influenza B is separately coated on the test line regions of
the test. During testing, the extracted specimen reacts with the
antibody to Influenza A and/or Influenza B that are coated onto
particles. The mixture migrates up the membrane to react with the
antibody to Influenza A and/or Influenza B on the membrane and
generate one or two colored
SPECIMEN COLLECTION, TRANSPORT AND STORAGE
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.
DIRECTIONS FOR USE
Allow the test, extracted specimen and/or controls to equilibrate
to 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.75-100μl) to each of the specimen well(S)
respectively 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.
POSITIVE COVID-19:* Two distinct colored lines appear in the left
window. One colored line should be in the control region (C) and
another colored line should be in the Test region (T). Positive
result in the Test region indicates detection of COVID-19
antigens in the sample.
POSITIVE Influenza A:* Two distinct colored lines appear in the
right window. One colored line should be in the control region (C)
and another colored line should be in the Influenza A region (A). A
positive result in the Influenza A region indicates that Influenza
A antigen was detected in the sample.
POSITIVE Influenza B:* Two distinct colored lines appearin the
right window. One colored line should be in the control region (C)
and another colored line should be in the Influenza B region (B). A
positive result in the Influenza B region indicates that Influenza
B antigen was detected in the sample.
POSITIVE Influenza A and Influenza B:* Three distinct colored lines
appear in the right window. One colored line should be in the
control region (C) and two colored line should be in the Influenza
A region (A) and Influenza B region (B). A positive result in the
Influenza A region and Influenza B region indicates that Influenza
A antigen and Influenza B antigen were detected in the sample.
*NOTE: The intensity of the color in the test line region (T) will
vary based on the amount of COVID-19 antigen, Flu A and/or B
antigen present in the sample. So any shade of color in the test
region (T/B/A) should be considered positive.
NEGATIVE: One colored line appears in the control region (C). No
apparent colored line appears in the test line region (T/B/A).
INVALID: Control line fails to appear. Insufficient specimen volume
or incorrect procedural techniques are the most likely reasons for
control line failure. Review the procedure and repeat the test with
a new test Cassette. If the problem persists, discontinue using the
test kit immediately and contact your local distributor
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.
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%. However, RT-PCR is expensive, complex and must be
performed in specialized laboratories.
ICIC-525 COVID 19 Antigen Rapid Test Kit Influenza AB Rapid Test Vitro Diagnostic
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