BakoID COVID Antibody

BakoDx is receiving COVID-19 specimens and performing testing.

Patients

Healthcare Providers

  • To inquire about using our lab for diagnostic testing, complete and submit the form at the bottom of this page.
  • For inquiries outside of COVID-19 testing, please use the Contact Us form.

About Serology Laboratory Testing

BakoID COVID Antibody is a SARS-CoV-2 Serology (COVID-19) Antibody (IgG), immunoassay test. This is a qualitative test to detect immunoglobulin G (IgG) antibodies to the SARS-CoV-2 virus in blood. IgG antibody testing should be performed to help identify people who may have been previously exposed to SARS-CoV-2 and may indicate prior infection which may be resolved or is still resolving, and/or protection against re-infection (“protective immunity”). This test is available pursuant to the U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for diagnostic testing in CLIA certified laboratories.

BakoID COVID Antibody, serological testing for the detection of IgG antibodies, is available to healthcare partners. According to the Centers for Disease Control and Prevention (CDC), testing for IgG may be a better marker of durable immunity for SARS-Cov-2. It is currently unclear how SARS-CoV-2 antibodies respond over time, or whether individuals with COVID-19 antibodies are less susceptible to future infection. A negative result does not rule out SARS-CoV-2 infection and a follow up molecular (RT-PCR) diagnostic test should be considered to rule out infection.

BakoID COVID Antibody Test Information

Facilities may utilize their own supplies provided they meet the specifications outlined below. Blood specimens for SARS-CoV-2 antibody testing can be collected in any healthcare setting where a licensed phlebotomist can draw blood.

Sample types accepted

• Human serum or EDTA

• Heparin

• Citrate plasma

Collection Tubes

• 4-5 mL Red top serum tubes

Stability of the patient samples:

The Clinical and Laboratory Standards Institute (CLSI GP44-A4) recommends the following storage conditions for samples:

• Samples should be stored at room temperature no longer than 8 hours.

• If the assay will not be completed within 8 hours, the samples should be refrigerated at +2°C to +8°C.

• If the assay will not be completed within 48 hours, or if the samples will be stored beyond 48 hours, samples should be frozen at

-20°C or lower.

The Clinical and Laboratory Standards Institute (CLSI GP44-A4) recommends the following storage conditions for samples:

• Samples should be stored at room temperature no longer than 8 hours.

• If the assay will not be completed within 8 hours, the samples should be refrigerated at +2°C to +8°C.

• If the assay will not be completed within 48 hours, or if the samples will be stored beyond 48 hours, samples should be frozen at

-20°C or lower.

  • Refrigerate at 4°C until transported to the lab.

  • Do not freeze whole blood or any samples stored in a primary tube.

  • A BakoDx test requisition form must accompany each specimen.

  • Two patient identifiers are needed on the requisition and the specimen.

  • Causes for Rejection:

    – Incomplete requisition form

    – Specimens beyond the acceptable length of time from collection as listed above

    – Specimen types other than those listed above in the Sample Collection Accepted section

    – Leaking containers

    – Gross hemolysis

    – Grossly lipemic or Grossly icteric

    – Frozen Serum Separator Tube (SST)

    – Fluids other than serum and CSF

  • Results are available within 24-36 hours of when the sample is received at the lab.
  • The most effective way to receive test results is to be set up with a BakoDx online portal account.
  • If EMR integration is required, our technical department can assist.
  • Reporting via fax is also available with phone calls for positive results.

Positive

IgG antibodies to SARS-CoV-2 were detected, and the individual has potentially been exposed to COVID-19.

Equivocal

A secure evaluation is not possible; IgG was detected at a level or close to the threshold of the limit of detection for the test. It is recommended the patient may be re-drawn one to two weeks later and re-tested with the BakoID™ COVID Antibody test.

Negative

The quantity of antibodies for the SARS-CoV-2 virus present in the specimen is below the detection limit of the test.

Measure Estimate Confidence Interval
IgG Sensitivity (PPA) 90.0% (27/30) (74.4%; 96.5%)
IgG Specificity (NPA) 100% (80/80) (95.4%; 100%)
PPV for prevalence = 5% 100% (46.0%; 100%)
NPV for prevalence = 5% 99.5% (98.6%; 99.8%)

$50 / Test

Getting started with BakoID COVID Antibody testing.

  • Complete and submit the form at the bottom of this page
  • Email us: COVID19Test@bakodx.com
  • Call us at: 1-855-422-5628

Other Resources

Request BakoID COVID Antibody Testing

If you are a healthcare provider or administrator of a healthcare facility and are interested in having testing provided by BakoDx, please provide your contact information below and someone will reach out to you soon.

Disclaimer: BakoDx, as a partner to your practice, provides learning resources to help you better serve your patients. The information contained within this document should be used at a physician’s discretion. BakoDx assumes no liability for its content.

FDA disclaimers:

• This test has not been FDA cleared or approved.

• This test has been authorized by FDA under an EUA for use by authorized laboratories.

• This test has been authorized only for the detection of IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens

• 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.

• Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals.

• Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.

• Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.