Yes. The MAKO COVID-19 [TagPath RT-PCR} (720100) is available for ordering by physicians and other authorized medical providers. The test detects the presence of the underlying virus (SARS-CoV-2) that causes COVID-19 and is for use with patients who meet current guidance for evaluation of infection with COVID-19.
MAKO utilizes Life Technologies QuantStudio 12K Flex Systems to perform TaqPath COVID-19 assays. This instrumentation is Real Time — Polymerase Chain Reaction.
MAKO utilizes the ThermoFisher TaqPath assay for COVID-19. The TaqPath assay has a targeted specificity is 100% of currently available complete genomes for SARS-CoV-2.
COVID-19 testing requires specimens collected from the nose or throat. The preferred sample types are nasopharyngeal (NP) or oropharyngeal (OP) swabs.
MAKO validated multiple collection media, including universal transport media, saline, and liquid amies. MAKO utilizes collection kits from Hardy Diagnostics, Puritan, Copan, Purflock, BD Viral Transport, and Starplex.
Samples/specimens should be shipped refrigerated if received for testing within 72 hours of collection, room temperature if received within 24 hours of collection, or frozen if samples are older than 72 hours and have been frozen prior.
Detailed illustrations and instructions for NP and OP specimen collection can be found on page four and five of this document.
Unacceptable specimens include those that are: Room temperature swabs greater than 24 hours old; Refrigerated swabs greater than 72 hours old; Calcium alginate tip swabs or swabs with wooden shafts Glass tubes Improperly labeled, contaminated, broken, or leaking transport device
MAKO will report results within 48 hours of receipt within the laboratory.
Test results will be reported as "positive" or "not detected."
Positive results are treated as a critical result and called to the ordering physician or health care provider. Negative results will not be called into the order provider.
The clinical spectrum of COVID-19 ranges from mild disease with non-specific signs and symptoms of acute respiratory illness, to severe pneumonia with respiratory failure and septic shock. There have also been reports of asymptomatic infection with COVID-19.
Mako does not plan to perform additional onsite confirmatory testing on positive or negative results unless the FDA or the CDC changes current recommendations. Mako will comply with applicable public health requirements or requests for specimens from state public health departments.
The test has been validated by FDA's independent review through the Emergency Use Authorization (EUA) process.