Novel Coronavirus (2019-nCoV) Antibody IgG/IgM Rapid Test Cassette
COVID-19 Rapid Teste Kit Novel Coronavirus Colloidal Gold Antibody
IgG/IgM Test Cassette
Main Features
| 1 | Fast to get the result in 15-20 mins |
| 2 | High sensitivity and specificity |
| 3 | Simple to use |
| 4 | High Accurate (97.51%) and Reliable (Credibility interval:
95.79%～98.67%) |
| 5 | Certified by Authoritative Certification |
| 6 | Ambient Storage |
| 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
COVID-19IgG/lgM Fast Diagnostic Cassette is for the detection of
lgG/lgM in human serum, plasma or whole blood.
It is used as a supplementary test indicator for suspected cases of
Novel Coronavirus negative nucleic acid detection or used combine
with nucleic acid detection in the diagnosis of suspected cased, It
cannot be used as the evidence for the diagnosis and exclusion of
COVID-19.
Materials Required But Not Provided
► Timer or stopwatch
► Blood collection devices, for the testing of venipuncture whole
blood, serum or plasma
► Biohazard disposal container
► Disposable gloves
► Pipette and pipette tip
For fingerstick samples, the following materials are required:
Alcohol pad
Sterile lancet
Sterile gauze or cotton
Cassette and Materials Provided
► Test cassette(individually pouched)
► Each pouch contains one cassette with one desiccant bag
► Diluent buffer
► Instruction for use
► Plastic dropper(optional)
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
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.
Storage
COVID-19 IgG/IgM Rapid Diagnostic Kit should be placed in dark
place at 2-30°C for 12 months from the date of manufacture.
Keep the test kit in sealed pouch until use. Once you have taken
the test cassette out of the pouch, use it immediately. Do not use
the test kit once it exceeds the indicated expiration date.
