Hardy Diagnostics products

An immunochromatographic rapid diagnostic test (RDT) intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct nasopharyngeal (NP) or anteriornasal (AN) swab specimens. Authorized for use under an Emergency Use Authorization (EUA) and for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.

A rapid immunoassay for the simultaneous direct detection and differential diagnosis of SARS-CoV-2, Influenza Type A and Type B antigen from anterior nasal (AN) or nasopharyngeal (NP) swab specimens. Kit includes extraction buffer vials and flocked nasopharyngeal (NP) swabs for superior specimen collection and patient comfort, and provides a visual read-out in 15 minutes with no equipment needed! This product is CLIA waived.

Intended use: Hardy Diagnostics Viral Transport Medium is recommended for the collection and transport of clinical specimens for the recovery of viral agents including, but not limited to, Herpes Simplex Type I, Herpes Simplex Type II, Cytomegalovirus (CMV), Influenza A, Influenza B, Respiratory Syncytial Virus (RSV), Echovirus, Adenovirus, etc. Storage: Media can be stored at room temperature (RT) 2-30°C  without decreased performance. Data permitting, the length of RT storage shall continue to be extended as the real-time findings are collected, and applied to each lot. For the length of allowable RT storage (post retrieval from 2-30°C conditions), please refer to the respective Certificate of Analysis for the lot-specific information.

The RightSign COVID-19 IgG/IgM Rapid Test Cassette is a lateral flow immunochromatographic assay for the detection of SARS-CoV-2 antibodies in venous whole blood, serum, or plasma. The COVID-19 IgG/IgM Rapid Test is intended for use as an aid in identifying individuals with an adaptive immune response (due to infection or vaccination) to SARS-CoV-2, indicating recent or prior infection.