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ANs - anterior nasal/nares
BAL(F) - bronchoalveolar lavage (fluid)
DBS - dry blood spot
GE - Genome Equivalents
IFU - Instructions For Use
LOD - Limit Of Detection. For CoV-2 EUA, FDA defines LOD as the lowest copy number where at least 19/20 samples deliver the correct result.
LRT - lower respiratory tract
MTNs - mid-turbinate nasal
NA - not applicable
ND - not disclosed
NPV - Negative Predictive Value - FDA calculator
NP - nasopharyngeal
Ns - nasal swab
OF - oral fluid
OP - oropharyngeal
Pla - Plasma
POC - Point of Care
PPV - Positive Predictive Value - FDA calculator
rRT-PCR - real-time reverse-transcriptase polymerase chain reaction
RT-LAMP - reverse-transcriptase loop-mediated isothermal amplification
Sal - saliva
Ser - serum
Spu - sputum
TAT - turn-around time
Tr - tracheal
URL - internet address for the test’s web page. If site has not been established this will direct to the company home page.
UTM - Universal Transport Medium
VTM - Viral Transport Medium
VWB - venous whole blood
Authorized settings per the FDA:
H - authorized for use in Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests.
M - authorized for use in laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity and moderate complexity tests.
W - authorized for use in laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity and moderate complexity tests, and deemed to be CLIA waived for use in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance.
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