Molecular Reagent Kit LumiraDx™ Real-time PCR SARS-CoV-2 RNA STAR Complete For use with Thermocycler 384 Tests

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, 2 mL Salt Mix, 1 mL extraction buffer, 240 µL internal control and primer mix, 2 X 2 mL Master Mix

Options for PCR Instruments (not provided): 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