SD Biosensor STANDARD Q COVID-19 IgM/IgG Combo Test Kit (Blood sample) - Box of 40 tests

This kit is a rapid immunochromatography test designed for the qualitative presumptive detection of specific IgM and IgG to 2019 novel coronavirus (nCoV) in humoral fluid.

SD Biosensor STANDARD Q COVID-19 IgM/IgG Combo Test Kit is a rapid immunochromatography test designed for the qualitative presumptive detection of specific IgM and IgG to SARS-CoV-2 in humoral fluid.

• Rapid testing for SARS-CoV-2 antibodies within 10~15 minutes
• Specimen : Whole blood (20ul), serum , plasma (10ul)
• Suitable for Point of Care Testing. No need for extra equipment
• Preferred by healthcare professionals and laboratories
• Made in Korea

Specification:

SD Biosensor STANDARD Q COVID-19 IgM/IgG Combo Test is a rapid chromatographic immunoassay for the qualitative detection of specific antibodies to SARSCoV- 2 present in human serum, plasma or whole blood. This test is for in vitro professional diagnostic use and intended as an aid to diagnosis of SARS-CoV-2 infection in convalescent phase of patient with clinical symptoms with SARSCoV- 2 infection. It provides only an initial screening test result. More specific alternative diagnosis methods should be performed in order to obtain the confirmation of SARS-CoV-2 infection.

Kit contents:

1. Test device (individually in a foil pouch with desiccant)
2. Buffer bottle
3. Capillary tube (20μl)
4. Instructions for use

Kit Storage and Stability:

• Store the kit at room temperature, 2-30°C / 36-86°F, out of direct sunlight.
• Kit materials are stable until the expiration date printed on the outer box.
• Do not freeze the kit.

Test sensitivity:

The seroconversion time of IgM and IgG antibodies varies from person to person, but it was estimated to be around 7 days after onset of symptom. The STANDARD Q COVID-19 IgM/IgG Combo Test showed 94.51% of sensitivity using specimens from patients 7 days after symptom onset (combined IgM+IgG).

Download the PDF with full details and instructions for use