CPT® Code 86408

1. Indications

The neutralizing antibody screening test for SARS-CoV-2 (CPT® Code 86408) is indicated for the following:

• Plasma Donor Eligibility This test is performed to determine if a post COVID-19 convalescent patient is eligible to donate plasma, which may contain antibodies beneficial for treating current COVID-19 patients.
• Immune Response Assessment The test is used to evaluate an individual's immune response to SARS-CoV-2, whether from a previous infection or vaccination, to ascertain their level of protection against infection or reinfection.

2. Procedure

The procedure for conducting the neutralizing antibody screening test involves several detailed steps:

• Sample Preparation Blood serum or plasma is collected from the individual being tested. This sample is then mixed with a test diluent to prepare it for the screening process.
• Incubation with Pseudovirus A synthetic virus that expresses the SARS-CoV-2 spike protein is added to the prepared serum or plasma mixture. This combination is placed in a multi-well plate, where it is allowed to incubate for a specified duration, facilitating interaction between the antibodies and the pseudovirus.
• Substrate Addition After the incubation period, a substrate is introduced to the wells of the multi-well plate. This substrate is designed to emit a luminescent signal in the presence of viral infection, indicating whether the antibodies have successfully neutralized the virus.
• Measurement and Analysis The luminescent signal produced is measured using a multi-well plate reader. The results are then compared to a control specimen to determine the qualitative outcome of the screening test.

3. Post-Procedure

Post-procedure, the results of the neutralizing antibody screening test are analyzed and reported. Individuals may receive guidance based on their test results, particularly regarding their immune status and potential eligibility for plasma donation. It is important for healthcare providers to discuss the implications of the results with the patient, including any necessary follow-up actions or additional testing that may be warranted based on the findings.