COVID-19 Antigen Rapid Test (Oral Fluid) ,Detection Of SARS-CoV-2
Nucleocapsid Protein Antigens
COVID-19 Antigen Rapid Test (Oral Fluid) , Detection of SARS-CoV-2
nucleocapsid protein antigens
COVID-19 Antigen Rapid Test is a rapid chromatographic immunoassay
for the qualitative detection of SARS-CoV-2 nucleocapsid protein
antigens present in human oral fluid.
For professional in vitro diagnostic use only.
INTENDED USE
The COVID-19 Antigen Rapid Test (Oral Fluid) is a rapid
chromatographic immunoassay for the qualitative detection of
SARS-CoV-2 nucleocapsid protein antigens in oral fluid 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 nucleocapsid protein
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 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.
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.
PRINCIPLE
The COVID-19 Antigen Rapid Test (Oral Fluid) is a qualitative
membrane-based immunoassay for the detection of SARS-CoV-2 nucleocapsid protein
antigens in human oral fluid specimen. SARS-CoV-2 nucleocapsid protein antibody
is coated in the test line region. During testing, the specimen reacts with
SARS-CoV-2 nucleocapsid protein antibody-coated particles in the test. The mixture then
migrates upward on the membrane by capillary action and reacts with the SARS-CoV-2
nucleocapsid protein
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.
REAGENTS
The test contains anti-SARS-CoV-2 nucleocapsid protein antibody as
the capture reagent and anti-SARS-CoV-2 nucleocapsid protein antibody as the
detection reagent.
DIRECTIONS FOR USE
Allow the test device, collection device, buffer and/or controls to
equilibrate to room temperature (15-30°C) prior to testing.
Specimen Collection
Important: Before collecting oral fluid, instruct the patients not
to place anything in the mouth including food, drink, gum or tobacco products for at
least 10 minutes prior to collection.
Instruct the patients to deeply cough 3-5 times. It is recommended to collect oral fluid after deep coughing in the
morning.
①Remove the collection device and collect oral fluid specimen.
If there’s not enough oral fluid collected, repeat the above
specimen collection steps.
Specimen Extraction
②Mix the buffer with the collected oral fluid. Gently shake or squeeze the tube with mixture for 10 seconds to mix
well.
NOTE: The storage of the specimen after extraction is stable for 2
hours at room temperature or 24 hours at 2-8°C.
Test Reaction
Remove the test device 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.
③Add Extracted specimen to the Test Device, Wait for the colored
line(s) to appear.
Read the result at 15 minutes. Do not interpret the result after 20
minutes. Refer to the Procedure Card for detailed information of the testing
procedure.
99.6% Specificity COVID 19 Antigen Rapid Test Kit CE1434 OTC Covid 19 Self Test Kit
