English | Chinese

Search form

FDA Emergency Use Authorization

The Lyra SARS-CoV-2 Assay is a real-time RT-PCR assay intended for the in vitro qualitative detection of human coronavirus SARS-CoV-2 from viral RNA extracted from nasal, nasopharyngeal (NP) or oropharyngeal (OP) swab specimens from patients with signs and symptoms of COVID-19. The Assay targets the non-structural Polyprotein (pp1ab) of the SARS-CoV-2 virus. The authorized testing consists of nucleic acid extraction on the bioMerieux NucliSENS® easyMAG® system or EMAG system, followed by RT-PCR on one of six thermocyclers: Applied Biosystems® 7500 Fast Dx, Applied Biosystems 7500 Standard, QuantStudioTM Real-Time PCR Instrument, Roche LightCycler® 480, BioRad CFX96 Touch, or Qiagen Rotor-Gene Q.

Quidel General Information for Lyra SARS-CoV-2 Assay

Where can I go for updates and more information?

General Information - Coronavirus (COVID-19)
Information for Healthcare Professionals
Information for Laboratories
Laboratory Biosafety
Isolation Precautions in Healthcare Settings
Specimen Collection
Infection Control

General Information - Coronavirus (COVID-19)
Emergency Use Authorizations
Additional Information - Quidel's EUA COVID-19 Products (Scroll down to the list of EUA products and enter “Quidel” in the search box)

Features & Benefits


One-step reagent set-up

Rehydration solution is simply added to the lyophilized Master Mix


Results in less than 75 minutes after extraction

Easy training

Simplified and uniform workflow with standard pipetting volumes

Refrigerated storage

No freezer needed. 2°C to 8°C storage

Flexible 96-test format

Kit includes vials of 12x8 Master Mix, Rehydration Solution and liquid Process Controls

Product Specifications

Product Spec NameProduct Spec Data
Sample type

Nasal, Nasopharyngeal (NP) or Oropharyngeal (OP) swab

Time to results

Less than 75 minutes after extraction

Reagent and Controls storage conditions

2°C to 8°C

Sample volume needed for extraction

180 µL

Ordering Information

Catalog NumberDescriptionKit Size / Case Size

Lyra SARS-CoV-2 Assay (includes controls)

96 tests

Lyra SARS-CoV-2 Assay (Microfuge Format) with Nasopharyngeal Swabs and Transport Tubes

96 tests, one 96-well Deep-well Plate, 100 NP Swabs, 100 Transport Media

Lyra SARS-CoV-2 Assay (Microwell Format) with Nasal/Oropharyngeal Swabs and Transport Tubes

96 tests, one 96-well Deep-well Plate, 100 Nasal/OP Swabs, 100 Transport Media