Vitro Diagnostic Whole Blood 2019-NCoV Rapid Detection Cassette

Novel Coronavirus (2019-nCoV) Antibody IgG/IgM Rapid Test Cassette

2019-NCoV Colloidal Gold Antibody IgG/IgM Rapid Detection Cassette For In Vitro Diagnostic Use

 

Main Features

 

1	Fast to get the result in 15-20 mins
2	High sensitivity and specificity
3	Simple to use.
4	High Accurate and Reliable
5	Ambient Storage
6	Certified by Authoritative Certification
7	Unique 3-line Patented Design
8	Meet Multiple Criteria as follows:    EN ISO 13485:2016 EN 13612:2002  EN ISO 14971:2012 EN ISO 23640:2015  EN ISO 18113-1:2011 EN ISO 18113-2:2011  EN ISO 15223-1:2016 EN13641:2002

 

Intended Use

The kit is used to detect the lgM and lgG antibodies to severe acute respiratory Syndrome corona virus 2 (SARS CoV-2) in human serum, plasma or whole blood sample qualitatively. Itis to be used as an aid in the diagnosis of Coronavirus infection disease (COVID- 19), which is caused bySARS-COV-2. The test provides preliminary test results. Negative results don't preclude SARSCOV-2 infection and they cannot be used as the sole basis for treatment or similar decision.

 

 

Principle

 

☀ This kit uses Colloidal Gold Immunochromatography and indirect immune capture principle of comprehensive detection technology to detect IgG/lgM of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in human serum, plasma and whole blood.

 

☀ During detection, the colloidal gold labeled recombinant antigens bind to the SARS-CoV-2 antibodies in the sample to form immune complexes. The immune complexes move forward along the cassette by chromatography.

 

☀ The IgM in the immune complexes will be captured by the pre-coated anti-human IgM on the test zone, condense the color to form the reaction line M. The IgG in the immune complexes will be captured by the pre-coated anti-human IgG on the test zone, condense the color to form the reaction line G.

 

☀ The colloidal gold-labeled chicken IgY antibodies are combined with the pre-coated goat anti-chicken IgY antibodies on the quality control line to form the quality control line C

 

 

Sample Collection and Test Preparation

 

Finger stick Specimens (Whole Blood)

☀ Clean the area to be lanced with an alcohol pad

☀ Squeeze the end of the fingertip and pierce it with a sterile lancet.

☀ Wipe away the first drop of blood with sterile gauze or cotton； collect the sample from the second drop

☀ Use dropper to draw the fresh blood to 1/ 2 of the tube wall and dispense into the sample well

 

Fingerstsick whole blood should be used immediately after can be used.

 

Serum/Plasma specimens:fresh serum or plasma specimen can be used.

 

Plasma

☀ Collect whole blood into a collection tube (containing EDTA, Na-citrate or heparin) by venipuncture

☀ Separate the plasma by centrifugation.

 

Serum

☀ Collect whole blood into a collection tube (containing no anticoagulants) by venipuncture.

☀ Allow the blood to clot.

☀ Separate the serum by centrifugation.

 

Avoid the use of hemolytic, turbid, microorganism contaminated specimens. Specimen should be stored at 2-8℃ for up to3 days or frozen at -20℃for up to 9 days. Avoid specimen deterioration by multiple freeze-thaw cycles

 

Venipuncture Whole Blood

Venipuncture whole blood can be used immediately after collection or stored up to 3 days at 2-8℃

 

 

Interpretation of Results

 

 

☀ Positive of lgG and IgM: if three lines appear in their respective zone C, G, M, then it Indicates IgG and IgM test result is positive.

 

☀ Positive of lgM: if two lines respectively appears in the line of Zone C and M, It indicates IgM test result is positive.

 

☀ Positive of IgG: if two lines respectively appears in the line of Zone C and G, It indicates lgG test result is positive.

 

☀ Negative of lgG and IgM: if Only one color line in the control zone C it indicates IgG and IgM test result is negative.

 

☀ Invalid: If no color line appears in the control zone C, then the test is invalid. Discard the test cassette and resume the performance with new cassette through correct procedures.

 

Sensitivity and Specificity

 

A total of 523 clinical samples were tested for validation, of which 142 were positive and 381 were negative. The test results are as follows:

 

NewScen	Clinical Sample Information				Total
	Positive		Negative
Positive	A	129	B	0	A+B	129
Negative	C	13	D	381	C+D	394
Total	A+C	142	B+D	381	A+B+ C+D	523

 

Positive Coincidence Rate

 

Positive Coincidence Rate: A/(A+C)%=90.85% (Credibility Interval: 84.85% ～95.04%)

Negative Coincidence Rate: D/(B+D)%=100.00% (Credibility Interval: 99.04%～100.00%)

Total Coincidence Rate: (A+D)/( A+B+ C+D)% = 97.51% (Credibility interval: 95.79%～98.67%)

 

Built-In Control

 

COVID-19 IgG/lgM Rapid Test Cassette has a built-in procedural control to see whether or not the operation is correct or effective, if one color line appeared on the control zone C, it indicates that the test operation is Correct.

 

Warning

 

For in vitro diagnostic use ONLY

Read the package insert completely before use.It is very important that the correct procedure is followed. Fail to add the patient sample may lead to a false negative result (i.e.a missed positive) .

 

Storage

 

COVID-19 IgG/IgM Rapid Test Cassette should be stored in dark place at 2-30°C for 12 months from the date of manufacture. Keep the test cassette in sealed pouch until use. Once you have taken the test cassette out of the pouch, use it immediately. Do not use the test beyond the indicated expiration date.