Testosterone, Total

Cleveland HeartLab Hormones, T, Test

NEW YORK DOH APPROVED: YES
CPT Code: 84403
Order Code: C156
ABN Requirement:  No
Synonyms: Total Testosterone
Specimen: Serum
Volume: 0.5 mL
Minimum Volume: 0.2 mL
Container: Gel-barrier tube (SST, Tiger Top)

Collection:

  1. Collect and label sample according to standard protocols.
  2. Gently invert tube 5 times immediately after draw. DO NOT SHAKE.
  3. Allow blood to clot 30 minutes.
  4. Centrifuge for 10 minutes.

Special Instructions: Samples should not be taken from patients receiving therapy with high biotin doses (>5 mg/day) until at least 8 hours following the last dose.

Transport: Store serum at 2°C to 8°C after collection and ship the same day per packaging instructions provided with the Cleveland HeartLab shipping box.

Stability:

Ambient (15-25°C): not acceptable
Refrigerated (2-8°C): 2 weeks
Frozen (-20°C): 6 months
Deep Frozen (-70°C): 6 months

Causes of Rejection: Samples from patients under Nandrolone treatment; samples which are heat-inactivated; specimens other than serum; improper labeling; samples not stored properly; samples older than stability limits

Methodology: Electrochemiluminescence Immunoassay (ECLIA)

Turn Around Time: 1 to 3 days

Reference Range:

Sex Age/Stage ng/dL
Male 18-49 Years 249-836
≥50 Years 193-740
Female 18-49 Years 8-48
≥50 Years 3-41
Male
(7-17 years)
Tanner Stage I <3
Tanner Stage II <3-432
Tanner Stage III 65-778
Tanner Stage IV 180-763
Tanner Stage V 188-882
Female
(8-17 years)
Tanner Stage I <3-6
Tanner Stage II <3-10
Tanner Stage III <3-24
Tanner Stage IV <3-27
Tanner Stage V 5-38

Note: Males <7 years and Females <8 years do not have an established reference interval.

Intended Use: The total testosterone test may be used to evaluate infertility, erectile dysfunction or osteoporosis in men and to evaluate hirsutism, polycystic ovarian disease and virilization in women. The test may also be used to monitor the efficacy of testosterone-lowering therapies in prostate cancer.

Limitations: Results from patients under Nandrolone treatment are unreliable. In women, therapy with estrogen can result in elevated testosterone levels, and in rare cases women with end stage renal disease. In rare cases, interference due to extremely high titers of antibodies to analyte-specific antibodies, streptavidin or ruthenium can occur.

Additional Information: Implausible elevated testosterone values in women should be verified by a LC-MS/MS method. Patients taking Norethisterone (19-Noresthisterone) or norethindrone may exhibit mildly elevated results. Interpret results with caution.

The CPT codes provided 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 payer being billed.