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Official Description

Immunoassay for infectious agent antibody(ies), qualitative or semiquantitative, single-step method (eg, reagent strip); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19])

© Copyright 2026 American Medical Association. All rights reserved.

Common Language Description

The CPT® Code 86328 refers to an immunoassay designed for the qualitative or semiquantitative detection of antibodies against the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which is responsible for coronavirus disease (COVID-19). This procedure utilizes a single-step method, commonly known as a rapid reagent test strip, which allows for a swift diagnosis within approximately 10 to 15 minutes. The test is particularly effective in identifying antibodies produced by the body in response to SARS-CoV-2 infection, typically detectable between 3 and 7 days after the onset of symptoms. The immunoassay is performed using a membrane-based test strip that can analyze serum, plasma, or whole blood samples. The test strip consists of specific regions: one for detecting IgG antibodies, another for IgM antibodies, and a control area to ensure the test is functioning correctly. When a blood sample is applied to the test strip, it interacts with SARS-CoV-2 antigen-coated particles, and the resulting mixture moves along the membrane through capillary action. The appearance of colored lines in the test regions indicates the presence of antibodies, while the control line confirms the validity of the test. This rapid testing method is crucial for timely diagnosis and management of COVID-19, providing healthcare professionals with immediate results to guide further clinical decisions.

© Copyright 2026 Coding Ahead. All rights reserved.

1. Indications

The immunoassay for SARS-CoV-2 antibodies, as described by CPT® Code 86328, is indicated for the following:

  • Diagnosis of COVID-19: The test is utilized to detect the presence of antibodies against SARS-CoV-2, aiding in the diagnosis of coronavirus disease (COVID-19) in individuals who may have been exposed to the virus.
  • Assessment of Immune Response: It helps in evaluating the immune response in patients who have recovered from COVID-19, determining whether they have developed antibodies that may confer some level of immunity.
  • Screening in Populations: The test can be used for screening purposes in various populations, including healthcare workers and individuals in congregate settings, to identify those who may have been previously infected.

2. Procedure

The procedure for conducting the immunoassay for SARS-CoV-2 antibodies involves several key steps:

  • Step 1: Sample Collection A sample of the patient's blood is collected, which can be serum, plasma, or whole blood, depending on the specific requirements of the test.
  • Step 2: Preparation of the Test Strip The rapid test cassette, which contains the immunoassay components, is prepared. This includes ensuring that the test strip is at room temperature and ready for use.
  • Step 3: Application of the Sample The collected blood sample is added to the specimen well of the test cassette. A diluent may also be added to facilitate the reaction.
  • Step 4: Reaction Process The blood sample interacts with the SARS-CoV-2 antigen-coated particles within the cassette. The mixture moves along the test membrane through capillary action, allowing for the detection of antibodies.
  • Step 5: Observation of Results After the appropriate reaction time, typically within 10 to 15 minutes, the test is evaluated. The appearance of colored lines in the IgG and IgM test regions indicates the presence of antibodies, while the control line confirms the test's validity.

3. Post-Procedure

After the immunoassay is completed, the results are read and reported. It is essential to interpret the results in conjunction with clinical findings and other diagnostic tests. If the test indicates the presence of IgG or IgM antibodies, further clinical evaluation may be warranted to assess the patient's condition and potential need for additional testing or treatment. Patients should be informed about the meaning of their test results, including the implications of positive or negative findings regarding their immune status and potential exposure to SARS-CoV-2. Follow-up care may be necessary based on the results and the patient's overall health status.

Short Descr IA NFCT AB SARSCOV2 COVID19
Medium Descr IA INFECTIOUS AGT ANTIBODY SARS-COV-2 COVID-19
Long Descr Immunoassay for infectious agent antibody(ies), qualitative or semiquantitative, single-step method (eg, reagent strip); severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (coronavirus disease [COVID-19])
Status Code Statutory Exclusion (from MPFS, may be paid under other methodologies)
Global Days XXX - Global Concept Does Not Apply
PC/TC Indicator (26, TC) 9 - Not Applicable
Multiple Procedures (51) 9 - Concept does not apply.
Bilateral Surgery (50) 9 - Concept does not apply.
Physician Supervisions 09 - Concept does not apply.
Assistant Surgeon (80, 82) 9 - Concept does not apply.
Co-Surgeons (62) 9 - Concept does not apply.
Team Surgery (66) 9 - Concept does not apply.
Diagnostic Imaging Family 99 - Concept Does Not Apply
CLIA Waived (QW) Yes
APC Status Indicator Service Paid under Fee Schedule or Payment System other than OPPS
Type of Service (TOS) 5 - Diagnostic Laboratory
Berenson-Eggers TOS (BETOS) none
MUE 3
QW Clia waived test
90 Reference (outside) laboratory: when laboratory procedures are performed by a party other than the treating or reporting physician or other qualified health care professional, the procedure may be identified by adding modifier 90 to the usual procedure number.
59 Distinct procedural service: under certain circumstances, it may be necessary to indicate that a procedure or service was distinct or independent from other non-e/m services performed on the same day. modifier 59 is used to identify procedures/services, other than e/m services, that are not normally reported together, but are appropriate under the circumstances. documentation must support a different session, different procedure or surgery, different site or organ system, separate incision/excision, separate lesion, or separate injury (or area of injury in extensive injuries) not ordinarily encountered or performed on the same day by the same individual. however, when another already established modifier is appropriate it should be used rather than modifier 59. only if no more descriptive modifier is available, and the use of modifier 59 best explains the circumstances, should modifier 59 be used. note: modifier 59 should not be appended to an e/m service. to report a separate and distinct e/m service with a non-e/m service performed on the same date, see modifier 25.
GV Attending physician not employed or paid under arrangement by the patient's hospice provider
77 Repeat procedure by another physician or other qualified health care professional: it may be necessary to indicate that a basic procedure or service was repeated by another physician or other qualified health care professional subsequent to the original procedure or service. this circumstance may be reported by adding modifier 77 to the repeated procedure or service. note: this modifier should not be appended to an e/m service.
95 Synchronous telemedicine service rendered via a real-time interactive audio and video telecommunications system: synchronous telemedicine service is defined as a real-time interaction between a physician or other qualified health care professional and a patient who is located at a distant site from the physician or other qualified health care professional. the totality of the communication of information exchanged between the physician or other qualified health care professional and the patient during the course of the synchronous telemedicine service must be of an amount and nature that would be sufficient to meet the key components and/or requirements of the same service when rendered via a face-to-face interaction. modifier 95 may only be appended to the services listed in appendix p. appendix p is the list of cpt codes for services that are typically performed face-to-face, but may be rendered via a real-time (synchronous) interactive audio and video telecommunications system.
CR Catastrophe/disaster related
CS Cost-sharing waived for specified covid-19 testing-related services that result in and order for or administration of a covid-19 test and/or used for cost-sharing waived preventive services furnished via telehealth in rural health clinics and federally qualified health centers during the covid-19 public health emergency
GA Waiver of liability statement issued as required by payer policy, individual case
GW Service not related to the hospice patient's terminal condition
Q5 Service furnished under a reciprocal billing arrangement by a substitute physician or by a substitute physical therapist furnishing outpatient physical therapy services in a health professional shortage area, a medically underserved area, or a rural area
SA Nurse practitioner rendering service in collaboration with a physician
SL State supplied vaccine
Date
Action
Notes
2022-01-01 Note Grammar correction
2022-01-01 Changed Code description changed.
2021-01-01 Added First appearance of addition in code book.
2021-01-01 Changed Code description changed.
2020-04-10 Added Code added.
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