Ordering Recommendation

Use to stratify the risk of aggressive prostate cancer in individuals 45 years or older with elevated prostate-specific antigen (PSA) for whom biopsy is being considered. This test should not be ordered if (1) prostate cancer was previously diagnosed; (2) digital rectal exam was performed within the last 4 days; (3) any procedure or therapy was used to treat symptomatic benign prostatic hyperplasia (BPH) within the past 6 months; (4) any invasive, urologic procedure that may be associated with a secondary PSA evaluation was performed within the past 6 months; (5) 5-alpha reductase inhibitor (5-ARI) therapy, such as Avodart (dutasteride) or Proscar (finasteride), was administered within the past 6 months.

New York DOH Approval Status

This test is New York state approved.

Specimen Required

Patient Preparation
Collect

Serum separator tube (SST).

Specimen Preparation

Transfer 4 mL serum to an ARUP standard transport tube. (Min: 3 mL)
Test is not performed at ARUP; separate specimens must be submitted when multiple tests are ordered.

Storage/Transport Temperature

Frozen.

Unacceptable Conditions

Frozen serum separator tubes (SST).

Remarks

Biopsy history and clinical indication for ordering are required. Digital Rectal Exam (DRE) result should be provided, if available.

Stability

Ambient: Unacceptable; Refrigerated: 72 hours; Frozen: 1 month

Methodology

Electrochemiluminescent Immunoassay (ECLIA)

Performed

Varies

Reported

5-10 days

Reference Interval

By report

Interpretive Data



Compliance Category

Performed by non-ARUP Laboratory

Note

4 Kallikrein Biomarkers: Total PSA, free PSA, percent free PSA, intact PSA, and hK2. Digital Rectal Exam (DRE) result should indicate "abnormal", "normal", or "unavailable". Test should not be ordered if DRE has been performed within the last 4 days or if biopsy history is positive. DREs performed after collection of specimen are acceptable.

Hotline History

N/A

CPT Codes

81539

Components

Component Test Code* Component Chart Name LOINC
2014060 4K - Biopsy History 66117-3
2014061 4K - Digital Rectal Exam (DRE) 10205-3
2014063 4K - Score 19146-0
2014309 4K - PSA, Total 83112-3
2014310 4K - PSA, Free 83113-1
2014311 4K - PSA, Percent Free 12841-3
3018825 4K - Clinical Indication for Order 104720-8
* Component test codes cannot be used to order tests. The information provided here is not sufficient for interface builds; for a complete test mix, please click the sidebar link to access the Interface Map.

Aliases

  • 4K Prostate Screen; Prostate test
  • Kallikrein score
Prostate-Specific Kallikrein, 4Kscore

BioReference Laboratories