Roche Immunoassay Reference Ranges
Roche Immunoassay Reference Ranges
Roche Immunoassay Reference Ranges
Effective November 14, 2016, Clinical Pathology Laboratories (CPL) will change the current immunochemistry
instrumentation and reagents to Roche COBAS® Electrochemiluminescent (eCLIA) methodology. As a result of
this change, all related reference ranges are reviewed. Ranges for certain analytes are modified in the validation
process, and additional interpretive notes or information are added for selected assays. Gender and age
stratification is applied as appropriate. The chart below summarizes all analytes to be performed on Roche
COBAS® eCLIA. Laboratory reports will be appended with a notice. As always, please review your laboratory
results in the context of the provided reference interval and flagging.
Please contact your Account Executive should you have any questions regarding this change.
9200 Wall Street |Austin, TX 78754 |www.CPLLABS.com | Issue Date: November 2016 Page 1 of 8
Unit Stage/Clinical Reference
Test Name Gender Age Units
Code Status Range
Male Tanner II ≤ 17.0 pg/mL
Male Tanner III ≤ 49.0 pg/mL
Male Tanner IV/V ≤ 49.0 pg/mL
Female 7-9 yrs. ≤ 51.0 pg/mL
Female 10-12 yrs. ≤ 116.0 pg/mL
Female 13-15 yrs. ≤ 324.0 pg/mL
Female 16-17 yrs. ≤ 346.0 pg/Ml
Female Tanner I ≤76.0.0 pg/mL
Female Tanner II ≤ 175.0 pg/mL
Female Tanner III 20.0-360.0 pg/mL
Female Tanner IV/V ≤ 337.0 pg/mL
2090 Ferritin Male 0-1 month 25-200 ng/mL
Male 2-5 months 50-200 ng/mL
Male 6 mos. – 15 yrs. 7-140 ng/mL
Male 16-150 yrs. 30-400 ng/mL
Female 0-1 month 25-200 ng/mL
Female 2-5 mos. 50-200 ng/mL
Female 6 mos. – 15 yrs. 7-140 ng/mL
Female 16 – 150 yrs. 13-200 ng/mL
2695 Folic Acid Female ≥ 6.0 µg/L
2700 FSH Male ≥18 yrs. 1.5-12.4 IU/L
Female ≥18 yrs. Follicular 3.5-12.5 IU/L
Female Mid-Cycle 4.7-21.5 IU/L
Female Luteal 1.7-7.7 IU/L
Female Post-Menopausal 25.8-134.8 IU/L
Male 4 wks. – 5 mos. 0.2-4.1 IU/L
Male 6 mos. – 2 yrs. 0.3-2.2 IU/L
Male 3-4 yrs. 0.3-2.3 IU/L
Male 5-6 yrs. 0.3-2.0 IU/L
Male 7-9 yrs. 0.3-2.6 IU/L
Male 10-12 yrs. 0.5-4.9 IU/L
Male 13-15 yrs. 1.1-7.4 IU/L
Male 16-17 yrs. 0.9-7.8 IU/L
Male Tanner I 0.3-2.9 IU/L
Male Tanner II 0.4-4.8 IU/L
Male Tanner III 1.0-6.6 IU/L
Male Tanner IV/V 1.0-8.2 IU/L
Female 4 wks. – 5 mos. 0.2-14.2 IU/L
Female 6 mos. – 2 yrs. 1.4-8.0 IU/L
Female 3-4 yrs. 0.6-5.0 IU/L
Female 5-6 yrs. 0.5-3.2 IU/L
Female 7-9 yrs. 0.4-4.4 IU/L
9200 Wall Street |Austin, TX 78754 |www.CPLLABS.com | Issue Date: November 2016 Page 2 of 8
Unit Stage/Clinical Reference
Test Name Gender Age Units
Code Status Range
Female 10-12 yrs. 0.7-8.3 IU/L
Female 13-15 yrs. 1.0-9.1 IU/L
Female 16-17 yrs. 0.4-9.9 IU/L
Female Tanner I 0.4-6.5 IU/L
Female Tanner II 1.0-8.4 IU/L
Female Tanner III 1.0-9.5 IU/L
Female Tanner IV/V 0.6-9.4 IU/L
2713 HCG Male 0-5 mIU/mL
Female Non-pregnant 0-5 mIU/mL
Female Post-menopausal ≤7 mIU/mL
Female GA 3 weeks 6-71 mIU/mL
Female GA 4 weeks 10-750 mIU/mL
Female GA 5 weeks 217-7,138 mIU/mL
Female GA 6 weeks 158-31,795 mIU/mL
GA 7 weeks 3,697- mIU/mL
Female
163,563
GA 8 weeks 32,065- mIU/mL
Female
149,571
GA 9 weeks 63,803- mIU/mL
Female
151,410
GA 10 weeks 46,509- mIU/mL
Female
186,977
GA 12 weeks 27,832- mIU/mL
Female
210,612
GA 14 weeks 13,950- mIU/mL
Female
62,530
GA 15 weeks 12,039- mIU/mL
Female
70,971
GA 16 weeks 9,040- mIU/mL
Female
56,451
GA 17 weeks 8,175- mIU/mL
Female
55,868
GA18 weeks 8,099- mIU/mL
Female
58,176
2776 LH Male ≥18 yrs. 1.2-8.6 IU/L
Female ≥18 yrs. Follicular 2.4-12.6 IU/L
Female Mid-Cycle 14.0-95.6 IU/L
Female Luteal 1.0-11.4 IU/L
Female Post-Menopausal 7.7-58.5 IU/L
Male 7-9 yrs. 0.0-0.7 IU/L
Male 10-12 yrs. 0.0-3.4 IU/L
Male 13-15 yrs. 0.3-5.6 IU/L
9200 Wall Street |Austin, TX 78754 |www.CPLLABS.com | Issue Date: November 2016 Page 3 of 8
Unit Stage/Clinical Reference
Test Name Gender Age Units
Code Status Range
Male 16-17 yrs. 1.1-9.0 IU/L
Male Tanner I 0.0-1.0 IU/L
Male Tanner II 0.0-3.6 IU/L
Male Tanner III 0.2-6.4 IU/L
Male Tanner IV/V 1.1-8.5 IU/L
Female 7-9 yrs. 0.0-0.7 IU/L
Female 10-12 yrs. 0.0-6.8 IU/L
Female 13-15 yrs. 0.0-23.0 IU/L
Female 16-17 yrs. 0.0-26.4 IU/L
Female Tanner I 0.0-2.8 IU/L
Female Tanner II 0.0-7.9 IU/L
Female Tanner III 0.0-23.0 IU/L
Female Tanner IV/V 0.0-25.3 IU/L
2790 Progesterone Male < 0.15 ng/mL
Female Follicular 0.06-0.89 ng/mL
Female Ovulation 0.12-12.00 ng/mL
Female Luteal 1.83-23.90 ng/mL
Female Post-Menopausal < 0.13 ng/mL
Female 1st Trimester 11.00-44.30 ng/mL
Female 2nd Trimester 25.40-83.30 ng/mL
Female 3rd Trimester 58.70-214.0 ng/mL
2800 Prolactin Male 4.0-15.2 ng/mL
Female Non-pregnant 4.8-23.3 ng/mL
2690 RBC Folate 499-1504 ng/mL
4600 Rubella IgG Reactive ≥ 10 IU/mL
2991 SHBG Male 1-7 days 12.3-46.2 nmol/L
Male 8-15 days 16.2-60.7 nmol/L
Male 16 days – 3 yrs. 21.1-97.5 nmol/L
Male 4-6 yrs. 32.9-119.1 nmol/L
Male 7-8 yrs. 39.8-102.3 nmol/L
Male 9-10 yrs. 29.6-141.6 nmol/L
Male 11 yrs. 43.0-129.1 nmol/L
Male 12 yrs. 30.0-145.3 nmol/L
Male 13 yrs. 23.6-133.5 nmol/L
Male 14 yrs. 16.9-86.4 nmol/L
Male 15 yrs. 19.5-120.3 nmol/L
Male 16 yrs. 19.6-96.5 nmol/L
Male 17 yrs. 21.0-67.6 nmol/L
Male 18-20 yrs. 14.5-56.2 nmol/L
Male 21-49 yrs. 16.5-55.9 nmol/L
Male ≥ 50 yrs. 19.3-76.4 nmol/L
Female 1-7 days 11.1-33.3 nmol/L
9200 Wall Street |Austin, TX 78754 |www.CPLLABS.com | Issue Date: November 2016 Page 4 of 8
Unit Stage/Clinical Reference
Test Name Gender Age Units
Code Status Range
Female 8-15 days 13.3-46.6 nmol/L
Female 16 days – 3 yrs. 15.6-83.2 nmol/L
Female 4-6 yrs. 39.4-110.7 nmol/L
Female 7-8 yrs. 38.9-125.7 nmol/L
Female 9-10 yrs. 29.7-148.9 nmol/L
Female 11 yrs. 33.3-132.7 nmol/L
Female 12 yrs. 29.8-121.5 nmol/L
Female 13 yrs. 25.5-134.3 nmol/L
Female 14 yrs. 16.0-113.6 nmol/L
Female 15 yrs. 25.4-130.1 nmol/L
Female 16 yrs. 27.7-137.8 nmol/L
Female 17 yrs. 24.4-109.4 nmol/L
Female 18-20 yrs. 23.5-124.9 nmol/L
Female 21-49 yrs. 24.6-122.0 nmol/L
Female ≥ 50 yrs. 17.3-125.0 nmol/L
4017 Troponin T <0.010 µg/L
2830 Testosterone Male 10-11 yrs. ≤ 150 ng/dL
Male 12-13 yrs. ≤ 561 ng/dL
Male 14-15 yrs. 28-664 ng/dL
Male 16-17 yrs. 143-749 ng/dL
Male Tanner I ≤ 14 ng/dL
Male Tanner II ≤ 275 ng/dL
Male Tanner III ≤ 771 ng/dL
Male Tanner IV/V 147-768 ng/dL
Male 18-39 yrs. 300-1080 ng/dL
Male 40-59 yrs. 300-890 ng/dL
Male ≥60 yrs. 300-720 ng/dL
Female 10-11 yrs. ≤ 29 ng/dL
Female 12-13 yrs. ≤ 45 ng/dL
Female 14-15 yrs. ≤ 47 ng/dL
Female 16-17 yrs. ≤ 53 ng/dL
Female Tanner I ≤ 15 ng/dL
Female Tanner II ≤ 36 ng/dL
Female Tanner III ≤ 57 ng/dL
Female Tanner IV/V ≤ 56 ng/dL
Female 18-59 yrs. < 50 ng/dL
Female ≥ 60 yrs. < 29 ng/dL
N/A Testosterone, Male 10-11 yrs. ≤ 0.6 ng/dL
Free Male 12-13 yrs. ≤ 10.3 ng/dL
Male 14-15 yrs. 0.2-14.5 ng/dL
Male 16-17 yrs. 3.9-18.2 ng/dL
Male Tanner I ≤ 0.3 ng/dL
9200 Wall Street |Austin, TX 78754 |www.CPLLABS.com | Issue Date: November 2016 Page 5 of 8
Unit Stage/Clinical Reference
Test Name Gender Age Units
Code Status Range
Male Tanner II ≤ 2.1 ng/dL
Male Tanner III ≤ 10.3 ng/dL
Male Tanner IV 3.6-17.8 ng/dL
Male Tanner V 4.2-25.2 ng/dL
Male ≥ 18 yrs. 4.8-25.7 ng/dL
Female 10-11yrs. ≤ 0.3 ng/dL
Female 12-13 yrs. ≤ 0.6 ng/dL
Female 14-15 yrs. ≤ 0.7 ng/dL
Female 16-17 yrs. ≤ 1.0 ng/dL
Female Tanner I ≤ 0.1 ng/dL
Female Tanner II ≤ 0.4 ng/dL
Female Tanner III 0.1-0.7 ng/dL
Female Tanner IV ≤ 1.6 ng/dL
Female Tanner V ≤ 0.9 ng/dL
Female 18-30 yrs. ≤ 0.7 ng/dL
Female 31-40 yrs. ≤ 0.9 ng/dL
Female 41-51 yrs. ≤ 0.5 ng/dL
Female ≥ 52 yrs. ≤0.3 ng/dL
2606 Total PSA Male ≤ 4.00 ng/mL
Total PSA,
2613 Male ≤ 30 yrs. 1.30 ng/mL
Age-Adjusted
Male 31-32 yrs. < 1.40 ng/mL
Male 33-34 yrs. < 1.60 ng/mL
Male 35-36 yrs. < 1.70 ng/mL
Male 37-38 yrs. < 1.80 ng/mL
Male 39-40 yrs. < 1.90 ng/mL
Male 41 yrs. < 2.00 ng/mL
Male 42-43 yrs. < 2.20 ng/mL
Male 44 yrs. < 2.30 ng/mL
Male 45-46 yrs. < 2.40 ng/mL
Male 47 yrs. < 2.50 ng/mL
Male 48 yrs. < 2.60 ng/mL
Male 49-50 yrs. < 2.80 ng/mL
Male 51 yrs. < 2.90 ng/mL
Male 52 yrs. < 3.00 ng/mL
Male 53 yrs. < 3.10 ng/mL
Male 54 yrs. < 3.30 ng/mL
Male 55 yrs. < 3.40 ng/mL
Male 56 yrs. < 3.50 ng/mL
Male 57 yrs. < 3.60 ng/mL
Male 58 yrs. < 3.70 ng/mL
Male ≥ 59 yrs. < 4.00 ng/mL
2840 Vitamin B-12 200-950 pg/mL
9200 Wall Street |Austin, TX 78754 |www.CPLLABS.com | Issue Date: November 2016 Page 6 of 8
Note: Several analytes are accompanied by additional interpretive information or methodology statements. Those
are as given below. With migration to Roche Cobas electrochemiluminescent immunoassay (ECLIA),
methodology, specific tumor marker specimens will be maintained for 30 days for comparative testing for re-base
lining with the prior method. Those are:
- CA15-3
- CA19-9
- CEA
- Prolactin
PSA specimens will be maintained for 7 days for re-base lining upon request. Please review laboratory results in
the context of the provided reference interval. Please contact Client Services to arrange parallel testing.
Unit
Test Name Interpretive Notes
Code
.
NOTE:
NEW METHODOLOGY IS ROCHE COBAS ELECTROCHEMILUMINESCENT IMMUNOASSAY (ECLIA)
4825 CA 15-3 ASSOCIATED WITH REFERENCE INTERVAL CHANGE. SPECIMEN IS RETAINED IN LABORATORY FOR 30
DAYS. IF INDICATED FOR COMPARATIVE TESTING, PLEASE CONTACT LABORATORY TO REASSESS WITH
PRIOR METHOD.
NOTE:
NEW METHODOLOGY IS ROCHE COBAS ELECTROCHEMILUMINESCENT IMMUNOASSAY (ECLIA).
4976 CA 19-9 SPECIMEN IS RETAINED IN LABORATORY FOR 30 DAYS. IF INDICATED FOR COMPARATIVE TESTING,
PLEASE CONTACT LABORATORY TO REASSESS WITH PRIOR METHOD.
NOTE 1:
In otherwise healthy smokers, 95% of patients fall in the range of 0.0-5.5 ng/mL.
NOTE 2:
2645 CEA NEW METHODOLOGY IS ROCHE COBAS ELECTROCHEMILUMINESCENT IMMUNOASSAY (ECLIA)
ASSOCIATED WITH REFERENCE INTERVAL CHANGE. SPECIMEN IS RETAINED IN LABORATORY FOR 30
DAYS. IF INDICATED FOR COMPARATIVE TESTING, PLEASE CONTACT LABORATORY TO REASSESS WITH
PRIOR METHOD.
NOTE:
3034 Digoxin CONCENTRATIONS ABOVE 2.0 NG/ML ARE GENERALLY CONSIDERED TOXIC. THE RECOMMENDED
THERAPEUTIC RANGE FOR DIGOXIN IS 0.6-1.2 NG/ML (ESC GUIDELINES, 2008).
NOTE:
***** INTERPRETIVE RANGES *****
2695 Folic Acid DEFICIENCY . . . . . . . . . . . . . . . UG/L <4.0
POSSIBLE DEFICIENCY. . . . . . . UG/L 4.0-5.9
SUFFICIENT . . . . . . . . . . . . . . . UG/L >=6.0
NOTE:
NEW METHODOLOGY IS ROCHE COBAS ELECTROCHEMILUMINESCENT IMMUNOASSAY (ECLIA)
2800 Prolactin ASSOCIATED WITH REFERENCE INTERVAL CHANGE. SPECIMEN IS RETAINED IN LABORATORY FOR 7
DAYS. IF INDICATED FOR COMPARATIVE TESTING, PLEASE CONTACT LABORATORY TO REASSESS WITH
PRIOR METHOD.
9200 Wall Street |Austin, TX 78754 |www.CPLLABS.com | Issue Date: November 2016 Page 7 of 8
NOTE:
***** INTERPRETIVE RANGES *****
DEFICIENCY . . . . . . . . . . . . . . . NG/ML <=150
2690 RBC Folate POSSIBLE DEFICIENCY. . . . . . NG/ML 151-498
SUFFICIENT . . . . . . . . . . . . . . . NG/ML 499-1504
EXCESS . . . . . . . . . . . . . . . . . NG/ML >1504
NOTE:
NEGATIVE: <0.010 UG/L
CARDIAC TROPONIN T (cTnT) IN THIS RANGE IS BELOW THE 99TH PERCENTILE OF APPARENTLY HEALTHY
ADULT PATIENTS.
LOW POSITIVE: 0.010-0.099 UG/L
4017 Troponin T cTnT VALUES IN THIS RANGE ARE ABOVE THE 99TH PERCENTILE BUT BELOW THE WORLD HEALTH
ORGANIZATION (WHO) AND RECEIVER OPERATOR CURVE (ROC) CUTOFFS. VALUES IN THIS RANGE MAY
REPRESENT MYOCARDIAL NECROSIS BUT OTHER CAUSES SUCH AS ANGINA, CONGESTIVE HEART
FAILURE, RENAL FAILURE AND PULMONARY EMBOLISM CANNOT BE EXCLUDED.
HIGH POSITIVE: >=0.100 UG/L
cTnT VALUES IN THIS RANGE ARE ABOVE WHO CUTOFF.
NOTE:
NEW METHODOLOGY IS ROCHE COBAS ELECTROCHEMILUMINESCENT IMMUNOASSAY (ECLIA).
2606 Total PSA SPECIMEN IS RETAINED IN LABORATORY FOR 7 DAYS. IF INDICATED FOR COMPARATIVE TESTING,
PLEASE CONTACT LABORATORY TO REASSESS WITH PRIOR METHOD.
9200 Wall Street |Austin, TX 78754 |www.CPLLABS.com | Issue Date: November 2016 Page 8 of 8