GenMark ePlex Controls
The ePlex SARS-CoV-2 Test is intended for the qualitative detection of SARS-CoV-2 nucleic acid in nasopharyngeal swab specimens (NPS) eluted in viral transport media (VTM) collected from individuals suspected of COVID-19 by their health care provider. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. § 263a, that meet requirements to perform moderate or high complexity tests.
Results are for the detection of SARS-CoV-2 RNA that are detectable in NPS specimens during infection. Positive results are indicative of active infection with SARS-CoV-2; 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 the disease. Laboratories within the United States and its territories are required to report all positive 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. Testing with the ePlex SARS-CoV-2 Test is intended for use by qualified and trained laboratory personnel who are have been trained and are proficient in performing testing on the ePlex system. The ePlex SARS-CoV-2 Test is only for use under the Food and Drug Administration’s Emergency Use Authorization.
SUMMARY AND EXPLANATION OF TEST
An outbreak of pneumonia caused by a novel coronavirus (SARS-CoV-2) in Wuhan City, Hubei Province, China was initially reported to the WHO on December 31, 2019. On January 31, 2020, Health and Human Services Secretary Alex M. Azar II declared a public health emergency for the United States to aid the nation’s healthcare community in responding to COVID-19.
The emergence and rapid spread of SARS-CoV-2 to numerous areas throughout the world necessitates preparedness and response in public health laboratories, as well as healthcare facilities and other areas of society in general. The availability of specific and sensitive assays for the detection of the virus is essential for accurate diagnosis of cases, assessment of the extent of the outbreak, monitoring of intervention strategies, and surveillance studies.
The ePlex SARS-CoV-2 Test is an automated qualitative nucleic acid in vitro diagnostic test that aids in the detection of SARS-CoV-2 and diagnosis of COVID-19 using The True Sample-to-Answer Solution ePlex instrument. The test is based on nucleic acid amplification technology and each test cartridge includes all reagents needed to extract, amplify and detect SARS-CoV-2 RNA in nasopharyngeal swab samples.
PRINCIPLES OF TECHNOLOGY
The True Sample-to-Answer Solution ePlex instrument automates all aspects of nucleic acid testing including extraction, amplification, and detection, combining electrowetting and GenMark’s eSensor® technology in a single-use cartridge. sensor technology is based on the principles of competitive DNA hybridization and electrochemical detection, which is highly specific and is not based on fluorescent or optical detection.
