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 must be provided at time of order.

Stability

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

Methodology

Electrochemiluminescent Immunoassay (ECLIA)

Performed

Varies

Reported

3-6 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. A digital rectal exam (DRE) is required and submissions should indicate "nodule" or "no nodule."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
* 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