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Official Description

Immunofluorescence, per specimen; initial single antibody stain procedure

© Copyright 2025 American Medical Association. All rights reserved.

Common Language Description

The CPT® Code 88346 refers to a laboratory procedure known as immunofluorescence, specifically for the initial single antibody stain performed on a specimen. This test is crucial for identifying the presence of specific antibodies within various types of specimens, which may include tissue sections, cultured cell lines, or individual cells. The process utilizes fluorescent staining techniques in conjunction with advanced microscopy methods, such as epifluorescence or confocal microscopy, to visualize the antibodies. In primary (direct) immunofluorescence, a single antibody is chemically linked to a fluorophore, allowing it to bind to the epitope region of the target antigen. When exposed to light, the fluorophore emits a specific wavelength that can be detected under the microscope, indicating the presence of the target antigen. Alternatively, secondary (indirect) immunofluorescence employs two antibodies: an unlabeled primary antibody that attaches to the target antigen and a labeled secondary antibody that binds to the primary antibody. This method can amplify the immunofluorescent signal, enhancing the detection of the target. The use of code 88346 is specifically for reporting the initial single antibody staining procedure, while code 88350 is designated for each additional single antibody stain performed on the same specimen.

© Copyright 2025 Coding Ahead. All rights reserved.

1. Indications

The immunofluorescence procedure represented by CPT® Code 88346 is indicated for various diagnostic purposes, particularly in the evaluation of autoimmune diseases, infectious diseases, and certain malignancies. The following conditions may warrant the use of this procedure:

  • Autoimmune Disorders The test is often utilized to detect specific autoantibodies that may indicate the presence of autoimmune conditions such as systemic lupus erythematosus, rheumatoid arthritis, and scleroderma.
  • Infectious Diseases Immunofluorescence can be employed to identify pathogens in tissue samples, aiding in the diagnosis of infections caused by viruses, bacteria, or fungi.
  • Malignancies The procedure may also be used to detect tumor markers or specific antigens associated with certain types of cancers, assisting in the diagnosis and management of malignancies.

2. Procedure

The immunofluorescence procedure involves several key steps to ensure accurate identification of antibodies within the specimen. The following outlines the procedural steps for the initial single antibody stain:

  • Step 1: Specimen Preparation The specimen, which may consist of tissue sections, cultured cell lines, or individual cells, is prepared for analysis. This involves fixing the specimen to preserve cellular structures and antigens, followed by appropriate sectioning or culturing techniques to facilitate staining.
  • Step 2: Application of Primary Antibody A single primary antibody, which is specific to the target antigen, is applied to the prepared specimen. This antibody is chemically linked to a fluorophore, allowing it to bind to the epitope region of the target antigen present in the specimen.
  • Step 3: Incubation The specimen is incubated for a specified period to allow the primary antibody to bind effectively to the target antigen. This step is critical for ensuring optimal binding and subsequent detection.
  • Step 4: Washing After incubation, the specimen is washed to remove any unbound primary antibodies. This step helps to reduce background noise and enhances the clarity of the results.
  • Step 5: Microscopy The specimen is then examined under an epifluorescence or confocal microscope. The fluorophore emits a specific wavelength of light when excited, allowing for the visualization of the bound antibody-antigen complexes. This step is essential for confirming the presence of the target antigen.

3. Post-Procedure

Following the immunofluorescence procedure, the specimen is analyzed, and results are documented. The expected recovery time for the specimen is minimal, as the procedure is primarily laboratory-based and does not involve patient intervention. However, it is essential to ensure that the results are interpreted by qualified personnel, as the findings can significantly impact diagnosis and treatment decisions. Additionally, any necessary follow-up testing or additional antibody stains can be performed as indicated, with subsequent procedures reported using CPT® Code 88350 for each additional single antibody stain.

Short Descr IMFLUOR 1ST 1ANTB STAIN PX
Medium Descr IMMUNOFLUORESCENCE PER SPEC 1ST SINGLE ANTB STN
Long Descr Immunofluorescence, per specimen; initial single antibody stain procedure
Status Code Active Code
Global Days XXX - Global Concept Does Not Apply
PC/TC Indicator (26, TC) 1 - Diagnostic Tests for Radiology Services
Multiple Procedures (51) 0 - No payment adjustment rules for multiple procedures apply.
Bilateral Surgery (50) 0 - 150% payment adjustment for bilateral procedures does NOT apply.
Physician Supervisions 09 - Concept does not apply.
Assistant Surgeon (80, 82) 0 - Payment restriction for assistants at surgery applies to this procedure...
Co-Surgeons (62) 0 - Co-surgeons not permitted for this procedure.
Team Surgery (66) 0 - Team surgeons not permitted for this procedure.
Diagnostic Imaging Family 99 - Concept Does Not Apply
APC Status Indicator T-Packaged Codes
Type of Service (TOS) 5 - Diagnostic Laboratory
Berenson-Eggers TOS (BETOS) T1G - Lab tests - other (Medicare fee schedule)
MUE 2
CCS Clinical Classification 234 - Pathology

This is a primary code that can be used with these additional add-on codes.

0845T Add On Code Resequenced Code MPFS Status: Carrier Priced APC N Digitization of glass microscope slides for immunofluorescence, per specimen; initial single antibody stain procedure (List separately in addition to code for primary procedure)
88350 Addon Code Resequenced Code MPFS Status: Active Code APC N Immunofluorescence, per specimen; each additional single antibody stain procedure (List separately in addition to code for primary procedure)
26 Professional component: certain procedures are a combination of a physician or other qualified health care professional component and a technical component. when the physician or other qualified health care professional component is reported separately, the service may be identified by adding modifier 26 to the usual procedure number.
GC This service has been performed in part by a resident under the direction of a teaching physician
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.
TC Technical component; under certain circumstances, a charge may be made for the technical component alone; under those circumstances the technical component charge is identified by adding modifier 'tc' to the usual procedure number; technical component charges are institutional charges and not billed separately by physicians; however, portable x-ray suppliers only bill for technical component and should utilize modifier tc; the charge data from portable x-ray suppliers will then be used to build customary and prevailing profiles
XU Unusual non-overlapping service, the use of a service that is distinct because it does not overlap usual components of the main service
XE Separate encounter, a service that is distinct because it occurred during a separate encounter
AQ Physician providing a service in an unlisted health professional shortage area (hpsa)
76 Repeat procedure or service by same physician or other qualified health care professional: it may be necessary to indicate that a procedure or service was repeated by the same physician or other qualified health care professional subsequent to the original procedure or service. this circumstance may be reported by adding modifier 76 to the repeated procedure or service. note: this modifier should not be appended to an e/m service.
CR Catastrophe/disaster related
91 Repeat clinical diagnostic laboratory test: in the course of treatment of the patient, it may be necessary to repeat the same laboratory test on the same day to obtain subsequent (multiple) test results. under these circumstances, the laboratory test performed can be identified by its usual procedure number and the addition of modifier 91. note: this modifier may not be used when tests are rerun to confirm initial results; due to testing problems with specimens or equipment; or for any other reason when a normal, one-time, reportable result is all that is required. this modifier may not be used when other code(s) describe a series of test results (eg, glucose tolerance tests, evocative/suppression testing). this modifier may only be used for laboratory test(s) performed more than once on the same day on the same patient.
X5 Diagnostic services requested by another clinician: for reporting services by a clinician who furnishes care to the patient only as requested by another clinician or subsequent and related services requested by another clinician; this modifier is reported for patient relationships that may not be adequately captured by the above alternative categories; reporting clinician service examples include but are not limited to, the radiologist's interpretation of an imaging study requested by another clinician
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.
XS Separate structure, a service that is distinct because it was performed on a separate organ/structure
52 Reduced services: under certain circumstances a service or procedure is partially reduced or eliminated at the discretion of the physician or other qualified health care professional. under these circumstances the service provided can be identified by its usual procedure number and the addition of modifier 52, signifying that the service is reduced. this provides a means of reporting reduced services without disturbing the identification of the basic service. note: for hospital outpatient reporting of a previously scheduled procedure/service that is partially reduced or cancelled as a result of extenuating circumstances or those that threaten the well-being of the patient prior to or after administration of anesthesia, see modifiers 73 and 74 (see modifiers approved for asc hospital outpatient use).
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.
CC Procedure code change (use 'cc' when the procedure code submitted was changed either for administrative reasons or because an incorrect code was filed)
GA Waiver of liability statement issued as required by payer policy, individual case
GT Via interactive audio and video telecommunication systems
GV Attending physician not employed or paid under arrangement by the patient's hospice provider
GW Service not related to the hospice patient's terminal condition
GZ Item or service expected to be denied as not reasonable and necessary
Q1 Routine clinical service provided in a clinical research study that is in an approved clinical research study
Q6 Service furnished under a fee-for-time compensation 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
XP Separate practitioner, a service that is distinct because it was performed by a different practitioner
Date
Action
Notes
2024-01-01 Changed Short and Medium Descriptions changed. Guideline added.
2016-01-01 Changed Description Changed
Pre-1990 Added Code added.
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