Test directory: SARS-CoV-2 Spike Total Ab, Semi-Qnt

Ordering Code7681
Test NameSARS-CoV-2 Spike Total Ab, Semi-Qnt
AliasAnti-SARS-CoV-2 S Total, Semi-Quantitative
SARS CoV-2 (COVID) S Total Ab, Semi-Quantitative
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
The sample may be frozen once
Rejection CriteriaInsufficient quantity, Specimen older than stability limits,
Heat-inactivated samples
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 Spike Total Ab, Semi-QntALLU/mL

INTERPRETIVE...

INTERPRETIVE INFORMATION
 
Result:                Interpretation:
<0.80 U/mL             Negative for Anti-SARS-CoV-2-S
>=0.80 U/mL            Positive for Anti-SARS-CoV-2-S,
                        numeric value within the measuring interval
>250.00 U/mL           Positive for Anti-SARS-CoV-2-S,
                        numeric value exceeds the measuring interval
 
For In vitro diagnostic use under the FDA Emergency Use Authorization
(EUA) only.
 
This detects antibody to the spike protein, which is the vaccine
component.  This test normally BECOMES POSITIVE in vaccinated
individuals, whereas Anti-SARS-CoV-2 test (nucleocapsid) remains
NEGATIVE.  In recently infected individuals, both this test and
the Anti-SARS-CoV-2 test (nucleocapsid) would be expected to be
positive.                                                     
 
Numerical results obtained from a single sample using similar tests
from different manufacturers can differ.
 
Results should be used in conjunction with other data to
diagnose or exclude acute SARS-CoV-2 infection.
 
The clinical applicability of semi-quantitative results is
currently unknown and cannot be interpreted as an indication
or degree of immunity nor protection from reinfection, nor
to other SARS-CoV-2 antibody assays.
 
A negative test result does not rule out the possibility of
an infection with SARS-CoV-2.  Samples collected early (pre-
seroconversion) 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 either past exposure to SARS-CoV-2
or vaccination; however, all conditions that may result in
a false positive have not been evaluated.  A second but
different serology test may be useful to confirm an immune
response.
 
Results should NOT be used to make decisions such as return
to work/school, to discontinue personal protective equipment,
or 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.