COVID-19 rapid test RightSignTM

for serologyIgGIgM

Product Overview
The RightSign COVID-19 IgG/IgM Rapid Test Cassette (Cat. No. INGM-MC42) is a lateral flow chromatographic immunoassay for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human venous whole blood (sodium heparin, potassium EDTA, sodium citrate), serum, plasma, and fingerstick whole blood. The device is intended for prescription use by healthcare professionals and authorized for use under Emergency Use Authorization. This product is for in vitro diagnostic use only.

Product Features

• For Emergency Use Authorization (EUA) only
• For prescription use only
• For in vitro diagnostic (IVD) use only
• Cassette format for rapid qualitative antibody detection

Performance
Combined results reported by manufacturer:

• Sensitivity (combined IgM/IgG): 100% (30/30)
• Specificity (combined IgM/IgG): 100% (80/80)
• PPV at prevalence = 5%: 100%
• NPV at prevalence = 5%: 100%

Product Specification

• Principle: Chromatographic immunoassay (lateral flow)
• Format: Cassette
• Regulatory status: FDA EUA
• Specimen types: Whole blood (venous and fingerstick), serum, plasma
• Operating temperature: 2-30 ℃
• Shelf life: 24 months

Ordering Information
Cat.No: INGM-MC42 - Product: RightSign COVID-19 IgG/IgM Rapid Test Cassette (EUA Fingerstick Blood) - Specimen: WB / S / P - Format: Cassette - Pack: 20/25 T

Technical Specifications

• Detection targets: IgM and IgG antibodies to SARS-CoV-2
• Sample volume and procedure: see manufacturer instructions for use
• Storage conditions: store at 2-30 ℃
• Kit contents: test cassettes, buffer, instructions (refer to IFU)