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Official Description

Chromogenic substrate assay

© Copyright 2025 American Medical Association. All rights reserved.

Common Language Description

The chromogenic substrate assay, identified by CPT® Code 85130, is a specialized analytical technique utilized to assess enzyme activity within biological samples. This method involves the addition of a chromogenic-linked substrate to a sample of body tissue or fluid, resulting in a color change that correlates with the activity level of the specific enzyme or factor being measured. The intensity of the color produced serves as an indicator of the relative activity of the target factor, allowing for quantitative analysis. This assay is particularly valuable in the context of evaluating the effects of anti-thrombotic medications, such as heparin, as well as in the assessment of anticoagulant proteins like antithrombin (AT) and Protein C (PC). Additionally, it plays a role in the analysis of various components of the fibrinolytic system. To perform this assay, a blood sample is required, which is obtained through a separately reportable venipuncture procedure. Furthermore, the assay can be employed to quantitatively test plasma for heparin cofactor II, enhancing its utility in clinical settings where monitoring of coagulation factors is essential.

© Copyright 2025 Coding Ahead. All rights reserved.

1. Indications

The chromogenic substrate assay is indicated for various clinical scenarios where enzyme activity needs to be evaluated. The following conditions and situations warrant the use of this assay:

  • Assessment of Anti-Thrombotic Drug Effects This assay is commonly used to monitor the activity of anti-thrombotic drugs, particularly heparin, to ensure therapeutic efficacy and safety.
  • Evaluation of Anticoagulant Proteins The assay is utilized to measure the activity levels of anticoagulant proteins such as antithrombin (AT) and Protein C (PC), which are critical in the regulation of blood coagulation.
  • Analysis of Fibrinolytic System Components It is also employed to assess various components of the fibrinolytic system, which is essential for understanding clot formation and dissolution.

2. Procedure

The procedure for conducting a chromogenic substrate assay involves several key steps that ensure accurate measurement of enzyme activity. The following outlines the procedural steps:

  • Step 1: Sample Collection A blood sample is obtained from the patient through a venipuncture. This step is crucial as it provides the necessary plasma for the assay. The venipuncture must be performed using standard protocols to ensure sample integrity.
  • Step 2: Plasma Preparation After collection, the blood sample is processed to separate the plasma from the cellular components. This is typically done by centrifugation, which allows for the isolation of the plasma that will be used in the assay.
  • Step 3: Addition of Chromogenic Substrate The prepared plasma is then mixed with a chromogenic-linked substrate. This substrate is specifically designed to react with the enzyme or factor of interest, leading to a color change that can be quantitatively measured.
  • Step 4: Measurement of Color Intensity Following the addition of the substrate, the intensity of the color produced is measured using a spectrophotometer. The degree of color change is directly proportional to the activity of the enzyme being assessed, allowing for accurate quantification.

3. Post-Procedure

After the chromogenic substrate assay is completed, the results are analyzed and interpreted by qualified healthcare professionals. It is important to ensure that the findings are documented accurately in the patient's medical record. Depending on the results, further clinical actions may be required, such as adjustments to anticoagulant therapy or additional testing. Patients may not require specific post-procedure care related to the assay itself, but standard post-venipuncture care should be provided to prevent complications such as hematoma or bleeding at the puncture site. Continuous monitoring of the patient's coagulation status may be necessary based on the assay results and the clinical context.

Short Descr CHROMOGENIC SUBSTRATE ASSAY
Medium Descr CHROMOGENIC SUBSTRATE ASSAY
Long Descr Chromogenic substrate assay
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) No
APC Status Indicator Conditionally packaged laboratory tests
Type of Service (TOS) 5 - Diagnostic Laboratory
Berenson-Eggers TOS (BETOS) T1H - Lab tests - other (non-Medicare fee schedule)
MUE 1
CCS Clinical Classification 233 - Laboratory - Chemistry and Hematology
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.
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.
GA Waiver of liability statement issued as required by payer policy, individual case
GY Item or service statutorily excluded, does not meet the definition of any medicare benefit or, for non-medicare insurers, is not a contract benefit
Date
Action
Notes
1993-01-01 Added First appearance in code book in 1993.
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Description
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