17-Hydroxyprogesterone Neonatal/Infant

Test Code
17654


CPT Codes
83498

Preferred Specimen
0.5 mL serum collected in a red-top tube (no gel)


Minimum Volume
0.25 mL


Other Acceptable Specimens
Plasma collected in: EDTA (lavender-top) tube, EDTA (royal blue-top) tube, sodium heparin (green-top) tube, or lithium heparin (green-top) tube


Instructions
A special sample handling bulletin is required for this assay in order to assure expedited testing. Contact Client Services at 1-800-553-5445 to request this special service.
SST tubes are unacceptable. Draw blood in a red-top tube (no gel). Separate serum after clotting. Ship serum refrigerated or frozen. Do not submit glass tubes.


Transport Temperature
Refrigerated (cold packs)


Specimen Stability
Room temperature: 48 hours
Refrigerated: 7 days
Frozen: 2 years


Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Gross hemolysis • Serum separator tubes (SST) • Glass tubes • Received room temperature


Methodology
Chromatography/Mass Spectrometry

FDA Status
This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by the U.S. Food and Drug Administration. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

Setup Schedule
Set up: Sun-Fri; Report available: 2-4 days


Reference Range
Pediatric
Cord Blood** 1000-3000 ng/dL
Premature Infants** (31-35 weeks) ≤405 ng/dL
Term Infants (12 hrs)** <460 ng/dL
Values decline gradually to prepubertal levels 
   
Male and Female  
  <30 days Not established
  1-11 months ≤147 ng/dL
  1 year ≤139 ng/dL
  2 years ≤134 ng/dL
  3 years ≤131 ng/dL
  4 years ≤131 ng/dL
  5 years ≤133 ng/dL
  6 years ≤137 ng/dL
  7 years ≤145 ng/dL
  8 years ≤154 ng/dL
  9 years ≤166 ng/dL
  10 years ≤180 ng/dL
  11 years ≤196 ng/dL
  12 years ≤213 ng/dL
  13 years ≤233 ng/dL
  14 years ≤254 ng/dL
  15 years 19-276 ng/dL
  16 years 23-300 ng/dL
  17 years 26-325 ng/dL

Tanner Stages**
II-III Males 12-130 ng/dL
II-III Females 18-220 ng/dL
IV-V Males 51-190 ng/dL
IV-V Females 36-200 ng/dL

**Includes data from J Clin Endocrinol Metab.1991;73:674-686; J Clin Endocrinol Metab. 1989; 69:1133-1136; and J Clin Endocrinol Metab. 1994; 78:266-270. Pediatr Res 1988;23:525-529. MedLinePlus (accessed 6/16/14).


Clinical Significance
17-Hydroxyprogesterone is elevated in patients with Congenital Adrenal Hyperplasia (CAH). CAH is a group of autosomal recessive diseases characterized by a deficiency of Cortisol and an excess of ACTH concentration. 17-Hydroxyprogesterone is also useful in monitoring Cortisol replacement therapy and in evaluating infertility and adrenal and ovarian neoplasms.




The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.