Amazon Real-Time RT-PCR Test for detecting SARS-CoV-2 receives FDA EUA
The Amazon Real-Time RT-PCR Test for Detecting SARS-CoV-2 (“Amazon Test”) will be performed at laboratories designated by STS Lab Holdco (a subsidiary of Amazon.com Services LLC) (“Amazon”) that are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a and meet the requirements to perform high complexity tests as described in the Laboratory Standard Operating Procedures that were reviewed by the FDA under this EUA), stated an emergency use authorization (EUA) summary from the U.S. Food and Drug Administration (FDA).
The Amazon Real-Time RT-PCR Test for Detecting SARS-CoV-2 (“Amazon Test”) is an in vitro diagnostic real-time reverse transcription polymerase chain reaction (rRT-PCR) test for the qualitative detection of nucleic acid from SARS-CoV-2 in anterior nasal swab specimens that are self-collected by any individuals (18 years of age or older), including individuals without symptoms or other reasons to suspect COVID-19, using either (1) the Amazon COVID-19 Collection Kit under the supervision of a healthcare provider (HCP) or, (2) the Amazon COVID19 Test Collection Kit unsupervised at home.
The Amazon Test is also intended for the qualitative detection of nucleic acid from SARS-CoV-2 in pooled samples containing up to five individual anterior nasal swab specimens per pool that are self-collected using the Amazon COVID-19 Collection Kit under the supervision of a healthcare provider in individual vials containing transport medium by any individual (18 years of age or older), including individuals without symptoms or other reasons to suspect COVID-19.
Testing is limited to laboratories designated by STS Lab Holdco (a subsidiary of Amazon.com Services LLC) that are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, and meet requirements to perform high complexity tests. Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in nasal swab specimens during the acute phase of infection.
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. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities.
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. Negative results from pooled testing should not be treated as definitive. If a patient’s clinical signs and symptoms are inconsistent with a negative result and if results are necessary for patient management, then the patient should be considered for individual testing. Specimens included in pools with a positive or invalid result must be tested individually prior to reporting a result. Specimens with low viral loads may not be detected in sample pools due to the decreased sensitivity of pooled testing.
The Amazon Test is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures. The Amazon Test with the Amazon COVID-19 Collection Kit and Amazon COVID19 Test Collection Kit is only for use under the FDA’s EUA.
