Description

Brand: LUNGENE
Packing:*5sets/box;***0sets/carton;

INTENDED USE
SARS-CoV*2 IgG/IgM Rapid Test Kits 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.

WARNINGS AND RECAUTIONS
For in virto 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 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.
 
COMPOSTION
Test Cassettes***5pcs;
Buffers***5bottles;
Laplace droppers***5pcs;
Blood sampling needles***5pcs;
Alcohol Pads***5pcs;
Material Required But Not Provided
Specimen collection container      Timer
SROPAGE AND STABILITY
Store as packaged in the sealed pouch at the temperature(***0°c or ****6°F). The kit is stable within the expiration date printed on the labeling.
Once open the puch, 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.
Strore specimens at **8°c(****6°F) if not tested immediately. Store specimens at **8°c up to 7 days. The specimens should be frozen at **0°c(*4°F) for longer storage. Do not freeze whole blood specimens.
Avoid multiple freeze-thaw cycles. Prior to testing, bring frozen specimens 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, groos hemolysis or turbidity in order to avoid interference on result interpretation.
 
TEST PROCEDURE
Allow the test device and specimens to equilibrate to temterature(****0°c or ****6°FG) prior to testing.

1. Remove the test cassettes from the sealed pouch.
2. Hold the dropper vertically and transfer 1 drop of specimen(approximately *0Ul) to the specimen well(S) of the test device, then add 2 drops of buffer (approximately *0ul) and start the timer. See the illustration below.
3. Wait for colored lines to appear. Interpret the test results in *5 minutes. Do

1. Other common causative agents of infectious diseases were evaluated for cross reactivity with the test. Some positive specimens of other common infectious diseases were spiked into the Novel coronavirus positive and negative specimens and tested separately. No cross reactivity was observed with specimens from patients infected with HIV, HAV, HBsag, HCV, TP, HtLV, CMV, FLUA, FLUB, RSV, MP. CP. HPIVs.
2. Potentially cross-reactive endogenous substances including common serum components, such as lipids, hemoglobin, bilirubin, were spiked at high concentrations nto the Novel coronavirus positive and negative specimens and tested, separately. No cross reactivity or interference was observed to the device.

1. Some other common biological analytes were spiked into the Novel coronavirus positive and negative specimens and tested separately. No significant interference was observed at the levels listed in the table below.