Test directory: SARS-CoV-2 NuclCapsd Total Ab, Qual

Ordering Code7203
Test NameSARS-CoV-2 NuclCapsd Total Ab, Qual
AliasSARS-CoV-2 Nuclelocapsid Total Ab, Qual
SARS-CoV-2 NC Total, Ab, Qual
SARS-CoV-2 (COVID) Total Ab, Qualitative
Anti-SARS-CoV-2 Total, Qualitative
Preferred SpecimenSerum
Preferred ContainerSST (Gold)
Other Specimen/ContainerPlasma in EDTA, K2 (Lavender),
Plasma in Lithium Heparin (Green), Serum in Plain (Red),
Plasma in EDTA, K3
Optimum Volume1 mL
Transport RequirementsOahu: Ambient
Airline: Refrigerated
Specimen StabilityAmbient: 3 Days
Refrigerated: 7 Days
Frozen: 28 Days
Rejection CriteriaInsufficient quantity, Pooled specimen, Specimen older than stability limits, Heat-inactivated samples, samples stabilized with azide
Avail. StatNO
Analytic TimeUp to 2 Days
MethodologyElectrochemiluminescence Immunoassay

Reference range(s)

ComponentAgeMale NormMale Critical LowMale Critical HighFemale NormFemale Critical HighFemale Critical LowUnitsAdd'l info
SARS-CoV-2 NuclCapsd Total Ab, QualALLSee report.
SARS-CoV-2 NC Total Ab Qual IndexALL

INTERPRETIVE...

INTERPRETIVE INFORMATION
 
Cutoff Index (COI) Value  Interpretation
------------------------  ------------------------------------------
COI <1.0                  Negative for Anti-SARS-CoV-2 NC Antibodies
COI >=1.0                 Positive for Anti-SARS-CoV-2 NC Antibodies
 
For in vitro diagnostic use under FDA Emergency Use Authorization
(EUA) only.
 
This test detects antibody to the nucleocapsid protein, but NOT
the spike protein, which is the vaccine component.  This test
normally REMAINS NEGATIVE IN VACCINATED Individuals.  In
recently infected individuals, both this test and the Anti-
SARS-CoV-2 Spike test would be expected to be positive.
 
The magnitude of the measured result above the cutoff is not
indicative of the total amount of antibody present in the sample.
 
The individual immune response following SARS-CoV-2 infection
varies considerably and might give different results with
assays from different manufacturers.  Results of assays from
different manufacturers should not be used interchangeably.
 
Results should be used in conjunction with other data and
NOT be used as the sole basis to diagnose or exclude
SARS-CoV-2 infection or to inform infection status.
 
A negative test result does not rule out the possibility
of an infection with SARS-CoV-2.  Samples collected early
(preseroconversion) in the illness can yield negative
findings.  A molecular test and NOT this test should be
used to diagnose an acute infection.
 
Positive results suggest past exposure to SARS-CoV-2;
however, all conditions that may result in a false
positive have not been evaluated.
 
It is not yet known how long antibody detected by this
test lasts or if it signifies immunity - partial or
complete.  Consequently, results should NOT be used to
make decisions such as return to work/school, to
discontinue social distancing measures.
 
Not to be used to screen units of blood for SARS-CoV-2
infection.
 
*Fact sheets for healthcare providers and receivers
are posted at https://www.fda.gov/emergency-preparedness-
and-response/mcm-legal-regulatory-and-policy-framework/
emergency-use-authorization.
See report.