COVID 19 Antigen Rapid Test Kit High Accuracy Nasopharyngeal Swab Test Kit Wiht LF Reader
Brand Name:Citest
Certification:CE
Model Number:INCP-R502
Minimum Order Quantity:N/A
Delivery Time:2-4 Weeks
Place of Origin:-
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Hangzhou Zhejiang
Address:
170-422, Richards Street, Vancouver BC V6B 2Z4, CANADA
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Product Details
COVID19 Antigen Rapid Test (Test with LF Reader), Nasopharyngeal Swab Specimen
| Product features | Parameters |
| Principle | Chromatographic Immunoassay |
| Format | Cassette |
| Specimen | Oral fluid/Nasopharyngeal Swab/Nasal Swab |
| Certificate | CE |
| Reading Time | 15 minutes |
| Pack | 20 T |
| Storage Temperature | 2-30°C |
| Shelf Life | 2 Years |
COVID19 Antigen Rapid Test is a rapid chromatographic immunoassay
for the qualitative detection of SARS-CoV-2 antigens present in
human nasopharynx that can be performed with the use of the Citest
LF Reader. For professional in vitro diagnostic use only.
INTENDED USE
The COVID-19 Antigen Rapid Test (Nasopharyngeal Swab) is a rapid
chromatographic immunoassay for the qualitative detection of
SARS-CoV-2 antigens in nasopharyngeal swab specimens from
individuals with suspected SARS-CoV-2 infection in conjunction with
clinical presentation and the results of other laboratory tests.
Results are for the detection of SARS-CoV-2 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 historyand
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 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.
The COVID-19 Antigen Rapid Test is intended for use by trained
clinical laboratory personnel.
PRINCIPLE
The COVID-19 Antigen Rapid Test (Nasopharyngeal Swab) is a
qualitative membrane-based immunoassay for the detection of
SARS-CoV-2 Antigens in human nasopharyngeal swab specimen.
SARS-CoV-2 antibody is coated in the 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
Antigens, 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.
STORAGE AND STABILITY
Store as packaged in the sealed pouch 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 beyond the
expiration date.
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.
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 8 hours at room temperature and 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. Exact QR Code from the QR code card for the specific information
of the test. Use only QR code card provided inside the test kits.
2. 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.
3. Invert the specimen extraction tube and add 3 drops of the
extracted specimen (approx.100μl) to the specimen well(S) and then
start the timer.
4. Wait for the colored line(s) to appear. The results should be
read with the Citest LF Reader at 15 minutes. Do not interpret test
results visually.
INTERPRETATION OF RESULTS
Results read by the Citest LF reader. The result of positive or
negative for SARS-CoV-2 antigens is determined by the LF reader. Result could be exported to excel or PDF
COVID 19 Antigen Rapid Test Kit High Accuracy Nasopharyngeal Swab Test Kit Wiht LF Reader
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