COVID-19 IgG/IgM detection kit
COVID-19 IgG/IgM detection kit. MAYPHARM
Specification
Match rate
| - after 5 day post-symptoms onset
- positive percent agreement: >90 %
- negative percent agreement: 95.7 %
|
Interference reaction
| As a result of testing with serum and plasma samples containing the pathogens( HIV, HBV, HCV, RSV, infuenza A/B, enterovirus 71), no false negative or false positive results were found. |
| Cross reaction | There were no false-negative or false-positive results in the tests using the following substances: hemoglobin, EDTA, HAMA, human IgG, human IgM, HSA) |
Feature
- Detectable in asymptomatic or latent stage
- Appropriate for testing bulk cases of patients after 5 days of infection
INTENDED USE
The SsmarTest COVID-19 IgM/IgG Detection Kit is an in vitro diagnostic medical device that measures the presence of differentiation of IgM and IgG antibodies to SARS-CoV-2 in human serum, plasma (EDTA, Citrate) or venipuncture whole blood specimens with immunochromatography and thus assists in diagnosing COVID-19. The test results are used in conjunction with other laboratory tests
INGRIDENTS
1) Device for test: There is a circular sample spot on the outside of the plastic device and the internal examination strips are colorless with sample pads, purple conjugated pads, white nitrocellulose membranes, and absorbent pads overlaid in turn.
2) Running solution: colorless or aesthetic liquid
3) Spuit: colorless polystyrene spuit
COVID-19 IgG/IgM detection kit. MAYPHARM
EXAMINATION PROCEDURE
All components of the inspection kit start at room temperature, since opening the silver foil with temperatures below room temperature may cause high moisture content of the device due to dew formation and thus decrease the power value.
1) Write the personal identification number of the sample on the device.
2) Using the enclosed spuit, 1 drop of sample is dispensed into the device. When dispensing the sample, be careful not to overflow the sample from the sample loading area.
3) When all samples are absorbed by the sample pad after completing the sample separation, drop 3 drops of the enclosed running solution into each specimen's lower.
4) Apply the running solution, set up the timer, determines the result after 15 to 20 minutes.
5) If more than 20 minutes have elapsed since the running solution has been dropped, a reinspection shall be performed.
Conclusion
1. Valid Result
1) When the C line appears and only the 1(or G) line appears, it indicates the presence of IgG anti-SARS-CoV-2 virus. These results is positive to SARS-CoV-2 that indicate was consistent with SARS-CoV-2 recent or previous infection.
2) When the red line appears on the C line and only on the 2 line (or M) of the test line, the test results indicate the presence of IgM anti-SARS-CoV-2 virus. This result is positive for IgM following acute or recent infection.
3) Red lines appear in the all lines (Control line, C line; Test lines, 2 and 1 lines) indicating the presence of IgM anti-SARS-CoV-2 virus and IgG anti-SARS-CoV-2 virus. These results indicate an infection of the current or recent SARS-CoV-2 virus
COVID-19 IgG/IgM detection kit. MAYPHARM. Valid Result
2. Invalid Result (Re-inspection)
1) Without any lines in tested samples: control line and test lines do not appear.
2) Without test lines in tested samples: Only control lines (C) appear.
COVID-19 IgG/IgM detection kit. MAYPHARM. Invalid Result
(Caution)
SARS-CoV-2 infection cannot be ruled out, even if the test results are negative for people living in areas with high levels of infection or contact with known confirmed persons. In order to rule out the infection of these individuals, follow-up tests using molecular diagnostic tests are necessary. Antibody test results cannot be used as the sole basis for diagnosing or excluding SARS-CoV-2 infections, and may result in false positive results from cross-reactive antibodies from other infections or previous infections such as other coronaviruses. Samples with positive results should be checked through molecular diagnostics and clinical results before an accurate diagnosis is made.
#Maypharm #health #medicine #virus #coronavirus #mask #UV #protection #drugs #dust #healthcare #finedust #sanitizer #celliance #cosmetics #cosmetology #fillers #toxin #pdrn #moisturization #antiaging #beauty #antibody #kit #virusdiagnostickit #sars #covid #detectionkit #examination #test
COVID-19 IgG/IgM detection kit
COVID-19 IgG/IgM detection kit. MAYPHARM
Specification
Match rate
Interference reaction
Feature
INTENDED USE
The SsmarTest COVID-19 IgM/IgG Detection Kit is an in vitro diagnostic medical device that measures the presence of differentiation of IgM and IgG antibodies to SARS-CoV-2 in human serum, plasma (EDTA, Citrate) or venipuncture whole blood specimens with immunochromatography and thus assists in diagnosing COVID-19. The test results are used in conjunction with other laboratory tests
INGRIDENTS
1) Device for test: There is a circular sample spot on the outside of the plastic device and the internal examination strips are colorless with sample pads, purple conjugated pads, white nitrocellulose membranes, and absorbent pads overlaid in turn.
2) Running solution: colorless or aesthetic liquid
3) Spuit: colorless polystyrene spuit
COVID-19 IgG/IgM detection kit. MAYPHARM
EXAMINATION PROCEDURE
All components of the inspection kit start at room temperature, since opening the silver foil with temperatures below room temperature may cause high moisture content of the device due to dew formation and thus decrease the power value.
1) Write the personal identification number of the sample on the device.
2) Using the enclosed spuit, 1 drop of sample is dispensed into the device. When dispensing the sample, be careful not to overflow the sample from the sample loading area.
3) When all samples are absorbed by the sample pad after completing the sample separation, drop 3 drops of the enclosed running solution into each specimen's lower.
4) Apply the running solution, set up the timer, determines the result after 15 to 20 minutes.
5) If more than 20 minutes have elapsed since the running solution has been dropped, a reinspection shall be performed.
Conclusion
1. Valid Result
1) When the C line appears and only the 1(or G) line appears, it indicates the presence of IgG anti-SARS-CoV-2 virus. These results is positive to SARS-CoV-2 that indicate was consistent with SARS-CoV-2 recent or previous infection.
2) When the red line appears on the C line and only on the 2 line (or M) of the test line, the test results indicate the presence of IgM anti-SARS-CoV-2 virus. This result is positive for IgM following acute or recent infection.
3) Red lines appear in the all lines (Control line, C line; Test lines, 2 and 1 lines) indicating the presence of IgM anti-SARS-CoV-2 virus and IgG anti-SARS-CoV-2 virus. These results indicate an infection of the current or recent SARS-CoV-2 virus
COVID-19 IgG/IgM detection kit. MAYPHARM. Valid Result
2. Invalid Result (Re-inspection)
1) Without any lines in tested samples: control line and test lines do not appear.
2) Without test lines in tested samples: Only control lines (C) appear.
COVID-19 IgG/IgM detection kit. MAYPHARM. Invalid Result
(Caution)
SARS-CoV-2 infection cannot be ruled out, even if the test results are negative for people living in areas with high levels of infection or contact with known confirmed persons. In order to rule out the infection of these individuals, follow-up tests using molecular diagnostic tests are necessary. Antibody test results cannot be used as the sole basis for diagnosing or excluding SARS-CoV-2 infections, and may result in false positive results from cross-reactive antibodies from other infections or previous infections such as other coronaviruses. Samples with positive results should be checked through molecular diagnostics and clinical results before an accurate diagnosis is made.
#Maypharm #health #medicine #virus #coronavirus #mask #UV #protection #drugs #dust #healthcare #finedust #sanitizer #celliance #cosmetics #cosmetology #fillers #toxin #pdrn #moisturization #antiaging #beauty #antibody #kit #virusdiagnostickit #sars #covid #detectionkit #examination #test