ABBOT RAPID LATERAL FLOW
FINGERSTICK IgG/IgM ASSAY
• Antibody tests are important to confirm
that an infection has occurred
• Rapid scale-up capability
• Time to result: 10–20 minutes
• Fingerstick whole blood, venous whole blood
or serum/plasma sample types
• Decentralized testing can help to alleviate
overcrowding in hospitals
• Useful in drive-through, home visit,
point-of-care, or lab settings
SPECIFICATIONS
INTENDED USE: An in vitro diagnostic rapid test for the qualitative detection of IgG and IgM antibodies to SARS-CoV-2 in human serum, plasma, venous and fingerstick whole blood. For professional use only.
Intended to be used as an aid in the diagnosis of SARS-CoV-2 infection. The product may be used in any laboratory and non-laboratory environment that meets the requirements specified in the Instructions for Use and local regulation. The test provides preliminary test results. Negative results will not preclude SARSCoV-2 infection, and they cannot be used as the sole basis for treatment or other management decisions.
The test is not intended to be used as a donor screening test for SARS-CoV-2.
• TEST TIME: 10–20 minutes
• SAMPLE TYPE: Fingerstick whole blood,
venous whole blood, serum/plasma
• SENSITIVITY: 95.8%
• SAMPLE SIZE:
• SPECIFICITY: 94.0%
• STORAGE: 2°C–30°C
– 20 μL fingerstick or venipuncture whole blood
– 10 μL serum or plasma
• CE MARK