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The point-of-care test provides results in 15 minutes and can be used for both symptomatic and asymptomatic patients.
Color Genomics' kit is designed for the unmonitored self-collection of nasal swab specimens for SARS-CoV-2 testing.
IVDs in the future will require certification in England, Scotland, and Wales, while companies will still be able to sell tests in Northern Ireland under existing EU regulations.
The tests are designed to detect antibodies against SARS-CoV-2 in order to help identify individuals with an adaptive immune response to the virus.
The tests are designed to detect viral RNA in individual respiratory specimens, while BayCare's tests can be used with pooled samples.
The test provides healthcare professionals with a single result to confirm HIV diagnosis and differentiate HIV-1 and HIV-2, enabling appropriate treatment options.
The two tests, both of which use RT-PCR technology to detect multiple viral targets, may be performed only by their respective developers.
The FDA does not allow labs to report hs-troponin results below assays' limits of quantitation, which some argue leaves actionable information on the table.
Under a proposed rule, devices given FDA's breakthrough designation would, upon receiving FDA market authorization, immediately be covered by Medicare.
The test is a version of Thermo Fisher Scientific's TaqPath COVID-19 Combo Kit that has been modified for use with a different PCR instrument and plate format.
The move raises questions about what precisely is an LDT outside of FDA jurisdiction and heightens concerns that poorly validated tests will enter the market and endanger public health.
KidneyIntelX is designed to help assess the risk of progressive decline in kidney function in patients with type 2 diabetes and chronic kidney disease.
The lateral flow test delivers results in 15 minutes without instrumentation and has a sensitivity of 97 percent and specificity of almost 99 percent.
QDx's RT-PCR-based test is designed to detect the SARS-CoV-2 N gene, while Biocan's immunoassay is designed to detect antibodies against the virus.
The PCR-based panel is designed to differentiate between SARS-CoV-2 and other common winter infections with high specificity and sensitivity.
Fluidigm's Advanta Dx SARS-CoV-2 RT-PCR assay is an extraction-free saliva-based test to detect nucleic acid from the SARS-CoV-2 virus.
Under the Emergency Use Authorizations, the RT-PCR tests may be performed by any laboratory CLIA-certified to perform high-complexity testing.
Streck said its collection tube maintains native cell-free DNA populations and provides sample integrity by reducing the release of cellular genomic DNA.
While observers are still sorting out the implications of the surprise announcement, it will likely limit the agency's role in regulating LDTs.
The action will immediately allow labs to offer SARS-CoV-2 LDTs without requiring EUA, and make it voluntary for labs to take LDTs through FDA premarket review.