Synonyms
- SARS-CoV-2 Antibody Titer
Special Instructions
On May 19, 2021, the FDA issued a safety communication reiterating that "antibody testing should not be used to evaluate a person's level of immunity or protection from COVID-19 at any time, and especially after the person received a COVID-19 vaccination." Visit http://www.fda.gov/medical-devices/safety-communications/antibody-testing-not-currently-recommended-assess-immunity-after-covid-19-vaccination-fda-safety for more information.
Expected Turnaround Time
1 - 3 days
Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.
Related Documents
Specimen Requirements
Specimen
Serum or plasma
Volume
1.5 mL
Minimum Volume
0.7 mL (Note: This volume does not allow for repeat testing.)
Container
Gel-barrier tube, red-top tube, or serum transfer tube, or plasma from lithium heparin tube, EDTA, or sodium citrate tube
Storage Instructions
Room temperature
Stability Requirements
Temperature | Period |
|---|---|
Room temperature | 14 days |
Refrigerated | 14 days |
Frozen | 28 days (stability provided by manufacturer or literature reference) |
Freeze/thaw cycles | Stable x3 |
Causes for Rejection
Gross hemolysis; visible microbial contamination
Test Details
Use
Qualitative and semi-quantitative detection of antibodies to SARS-CoV-2 spike protein receptor binding domain (RBD). Aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. At this time it is unknown how long antibodies persist following infection and if the presence of antibodies confers protective immunity. The performance of this test has not been established in individuals that have received a COVID-19 vaccine. The clinical significance of a positive or negative antibody result following COVID-19 vaccination has not been established and the result from this test should not be interpreted as an indication or degree of protection from infection after vaccination.
Limitations
This test should not be used to diagnose or exclude acute SARS-CoV-2 infection. The results should always be assessed in conjunction with patient's medical history, clinical presentation, and other findings. A negative test result does not rule out the possibility of an infection with SARS-CoV-2. Serum or plasma samples from the very early (pre-seroconversion) phase can yield negative findings. Therefore, this test cannot be used to diagnose an acute infection. It has also been reported that certain patients with confirmed infection do not develop SARS-CoV-2 antibodies. Furthermore, waning of antibody titers has been reported in some individuals within a range of months after infection, a feature which has also been reported for other coronaviruses.
This test has not been FDA cleared or approved. This test has been authorized by FDA under an Emergency Use Authorization (EUA). This test is only authorized for the duration of the declaration that circumstances exist, justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. This test has been authorized only for detecting the presence of antibodies against SARS-CoV-2, not for any other viruses or pathogens.
Methodology
Electrochemiluminescence Immunoassay (ECLIA)
Additional Information
FDA-authorized Fact sheets for patients and providers canbe accessed at the following link: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations#covid19ivd
LOINC® Map
| Order Code | Order Code Name | Order Loinc | Result Code | Result Code Name | UofM | Result LOINC |
|---|---|---|---|---|---|---|
| 164090 | SARS-CoV-2 Semi-Quant Spike Ab | 94769-7 | 164091 | SARS-CoV-2 Semi-Quant Spike Ab | U/mL | 94769-7 |
| 164090 | SARS-CoV-2 Semi-Quant Spike Ab | 94769-7 | 164092 | SARS-CoV-2 Spike Ab Interp | 94661-6 |
| Reflex Table for SARS-CoV-2 Semi-Quant Spike Ab | ||||||
|---|---|---|---|---|---|---|
| Order Code | Order Name | Result Code | Result Name | UofM | Result LOINC | |
| Reflex 1 | 164093 | SARS-CoV-2 Spike Ab Dilution | 164093 | SARS-CoV-2 Spike Ab Dilution | U/mL | 94769-7 |
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