|
[INTENDED USE]
The
COVID-19 IgG/IgM Rapid Test Cassette is a lateral flow chromatographic
immunoassay for the qualitative detection of antibodies
(IgG
and IgM) to Novel coronavirus in human Whole Blood/Serum/Plasma.It
provides an aid in the diagnosis of infection with Novel coronavirus. [PRINCIPLE]
The
COVID-19 IgG/IgM Rapid Test Cassette is a qualitative membrane strip
based immunoassay for the detection of antibodies (IgG and IgM) to Novel
coronavirus in human Whole Blood/Serum/Plasma. The test cassette
consists of: 1) a burgundy colored conjugate pad containing Novel
coronavirus recombinant envelope antigens conjugated with Colloid gold
(Novel coronavirus conjugates), 2) a nitrocellulose membrane strip
containing two test lines (IgG and IgM lines) and a control line (C
line). The IgM line is pre-coated with the Mouse anti-Human IgM
antibody, IgG line is coated with Mouse anti-Human IgG antibody. When an
adequate volume of test specimen is dispensed into the sample well of
the test cassette, the specimen migrates by capillary action across the
cassette. IgM anti-Novel
coronavirus,
if present in the specimen, will bind to the Novel coronavirus
conjugates. The immunocomplex is then captured by the reagent pre-coated
on the IgM band, forming a burgundy colored IgM line, indicating a
Novel coronavirus IgM positive test result. IgG anti-Novel coronavirus
if present in the specimen will bind to the Novel coronavirus
conjugates. Theimmunocomplex is then captured by the reagent coated on
the IgG line,forming a burgundy colored IgG line, indicating a Novel
coronavirus IgG positive test result. Absence of any T lines (IgG and
IgM) suggests anegative result. To serve as a procedural control, a
colored line will always
appear at the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred. [WARNINGS AND PRECAUTIONS] For in vitro diagnostic use only.
For healthcare professionals and professionals at point of care sites.
Do not use after the expiration date.
Please read all the information in this leaflet before performing the
test.The test cassette should remain in the sealed pouch until use.
All specimens should be considered potentially hazardous and handled in the same manner as an infectious agent.
The used test cassette should be discarded according to federal, state and local regulations.
[COMPOSITION]
The
test contains a membrane strip coated with Mouse anti-Human IgM
antibody and Mouse anti-Human IgG antibody on the test line, and a dye
pad which contains colloidal gold coupled with Novel coronavirus
recombinant antigen.The quantity of tests was printed on the labeling. [STORAGE AND STABILITY]
Store as packaged in the sealed pouch at the temperature (4-30℃ or
40-86℉). The kit is stable within the expiration date printed on the
labeling.Once
open the pouch, the test should be used within one hour.Prolonged
exposure to hot and humid environment will cause product
deterioration.The LOT and the expiration date were printed on the
labeling.
[SPECIMEN]
The test can be used to test Whole Blood/Serum/Plasma specimens.To
collect whole blood, serum or plasma specimens following regular
clinical laboratory procedures.Separate serum or plasma from blood as
soon as possible to avoid hemolysis. Use only clear non-hemolyzed
specimens. Store specimens at 2-8℃ (36-46℉) if not tested immediately.
Storespecimens at 2-8℃ up to 7 days. The specimens should be frozen
at-20℃ (-4℉) for longer storage. Do not freeze whole blood
specimens.Avoid multiple freeze-thaw cycles. Prior to testing, bring
frozenspecimens to room temperature slowly and mix gently. Specimens
containing visible particulate matter should be clarified by
centrifugation before testing.Do not use samples demonstrating gross
lipemia, gross hemolysis or
turbidity in order to avoid interference on result interpretation. [TEST PROCEDURE]
Allow the test device and specimens to equilibrate to temperature(15-30℃or 59-86℉) prior to testing.
1. Remove the test cassette from the sealed pouch.
2.
Hold the dropper vertically and transfer 1 drop of specimen to the
specimen well(S) of the test device, then add 2 drops of buffer
(approximately 70μl) and start the timer. See the illustration below.
3. Wait for colored lines to appear. Interpret the test results in 15 minutes.Do not read results after 20 minutes.
|
