Ordering Code | 7203 |
---|---|
Test Name | SARS-CoV-2 NuclCapsd Total Ab, Qual |
Alias | SARS-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 Specimen | Serum |
Preferred Container | SST (Gold) |
Other Specimen/Container | Plasma in EDTA, K2 (Lavender), Plasma in Lithium Heparin (Green), Serum in Plain (Red), Plasma in EDTA, K3 |
Optimum Volume | 1 mL |
Handling Instructions | ADD-ON WARNING: LIS may restrict add-on requests for this specific test based on available tubes due to the potential of carryover that exists when adding on to previously aliquoted tubes using non-disposable pipettes. |
Transport Requirements | Oahu: Ambient Airline: Refrigerated |
Specimen Stability | Ambient: 3 Days Refrigerated: 7 Days Frozen: 28 Days |
Rejection Criteria | Insufficient quantity, Pooled specimen, Specimen older than stability limits, Heat-inactivated samples, samples stabilized with azide |
Avail. Stat | NO |
Analytic Time | Up to 2 Days |
Methodology | Electrochemiluminescence Immunoassay |
Reference range(s)
The reference ranges listed below are valid on this date of April 18, 2024.
Component | Age | Male Norm | Male Critical Low | Male Critical High | Female Norm | Female Critical High | Female Critical Low | Units | Add'l info |
---|---|---|---|---|---|---|---|---|---|
SARS-CoV-2 NuclCapsd Total Ab, Qual | ALL | See report. | |||||||
SARS-CoV-2 NC Total Ab Qual Index | ALL | INTERPRETIVE... Note1 |
Note1:
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.
Elecsys Anti-SARS-CoV-2 - Recipient Fact Sheet
https://dlslab.com/documents/ref/2023/eua-137604.pdf
See report..