Medical Necessity Documentation:
Client Notes:
Patient Preparation:
The 4K Score test is limited to patients age 40 and over.
Specimen Requirements:
4.0 mL Serum from a SST Gold Top Tube
Collection Instructions:
Fill tube, invert gently 5 times, label with patient name, let stand for minimum of 30 minutes, maximum of 1 hr, spin for 10-15 minutes
Biopsy history must be provided
Minimum Volume:
3.0 mL Serum
Transport & Storage: Temperature/Stability:
**SPECIMEN MUST BE SHIPPED WITHIN 24HRS OF COLLECTION**
Transport Frozen
Rejection Criteria:
Received beyond 72 hours from collection • hemolyzed • lipemic
Reference Range:
Critical Ranges:
Test Comments:
Methodology:
Electrochemiluminescene Immunoassay
Clinical Significance:
The 4Kscore Test is an in vitro diagnostic test system designed to evaluate a patient’s likelihood of aggressive prostate cancer by measuring concentrations of four proteins(total PSA, free PSA, intact PSA, and kallikrein 2) in a patient’s blood sample, along with a patient’s age, previous biopsy, and digital rectal exam results.
Documentation:
4 Kallikrein Biomarkers: Total PSA, Free PSA, percent free PSA, Intact PSA and hK2. Test should not be ordered if Digital Rectal Exam (DRE) has been performed within the last 4 days or if biopsy history is positive
Custom Panel:
No
PRODUCTION SCHEDULE
Turn Around Time:
2 to 3 days
Sites Performed:
GenPath Diagnostics
Other Testing Facility:
Bio Reference Laboratories
PHL Test Code:
MSOT
EPIC Test Code:
MISC
Send Out Test Code:
J148-8
Alternate Test Names:
4K Prostate Screen; 4Kscore; Four K; Kallikrein Score
Included Tests:
PSA Total, PSA, FREE
CPT Coding:
81539