Molecular Reagent LumiraDx™ SARS-CoV-2 RNA STAR Complete For Thermocycler 96 Tests

Features

• The LumiraDX SARS-CoV-2 RNA STAR Complete is for Emergency Use Authorization (EUA) Only: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-molecular-diagnostic-tests-sars-cov-2#individual-molecular
• LumiraDx SARS-CoV-2 RNA STAR Complete is a rapid, non-isothermal nucleic acid amplification qSTAR (Selective Temperature Amplification Reaction) method intended for the qualitative detection of nucleic acid from SARS-CoV-2 in anterior nasal, mid-turbinate nasal, nasopharyngeal and oropharyngeal swab specimens collected dry or in transport media from individuals suspected of COVID-19 by their healthcare provider (HCP)
• This test is also authorized for use with anterior nasal swab specimens collected dry or in transport media from any individual, including individuals without symptoms or other reasons to suspect COVID-19 when collected by a HCP or self-collected under the supervision of a HCP
• This test is also authorized for use with anterior nasal swab specimens that are collected using a collection kit that conforms to HealthPulse@home when used consistent with its authorization
• Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 USC. §263a that meet requirements to perform high complexity tests
• Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions; negative results must be combined with clinical observations, patient history, and epidemiological information
• Specimens included in pools with a positive or presumptive positive result must be tested individually prior to reporting a result
• Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status
• Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities
• Materials provided: 500 µL positive control media, 1.5 mL negative control media, 1 mL Salt Mix, 500 µL extraction buffer, 120 µL internal control and primer mix, 2 X 1 mL Master Mix
• Options for PCR Instruments: Roche LightCycler 480 II (software version SW 1.5.1), Applied Biosystems 7500 Fast Dx (software version 1.4.1), Applied Biosystems QuantStudio 5 (software version 1.5.1), Applied Biosystems QuantStudio 7 Flex (software version 1.3), Applied Biosystems QuantStudio 7 Pro (software version 2.4.3), Bio-Rad CFX96 Touch System (software version 3.1), Agilent AriaMx (software version 1.71), Agilent Stratagene Mx3005P (software version 4.10) or the Analytik Jena qTOWER3 (software version 4.1) RT-PCR Instruments
• Reliable and robust performance when compared to traditional RT-PCR tests
• Increased throughput with 5:1 pooling on 96-well RT-PCR instruments
• Direct amplification within 20 minutes drives lab's efficiency and productivity
• Authorized with HealthPulse@home for at-home collection by any individual aged 16 years and older (self-collected), or 2 years and older (collected with adult assistance), including individuals without symptoms or other reasons to suspect COVID-19

More Information

• LumiraDx SARS-CoV-2 RNA Star Complete EUA Letter
• LumiraDx SARS-CoV-2 RNA Star Complete IFU
• LumiraDx SARS-CoV-2 RNA STAR Complete Healthcare Providers Fact Sheet
• LumiraDx SARS-CoV-2 RNA Star Complete Patients Fact Sheet
• LumiraDx SARS-CoV-2 RNA STAR Complete Quick Reference