Fragile X, PCR and southern blot analysis-13566

1/15/2024:  This test has been discontinued. To order a referred alternate, place an MSO order for LabCorp 481701 Fragile X Syndrome, Diagnostic

Test info

  
Fragile X, PCR and southern blot analysis
  
13566
  
LAB13566
  
FRAXA
  

Diagnostic testing for:

  • Unexplained intellectual disabilities, developmental delay or autism
  • Women with primary ovarian insufficiency or failure, premature menopause, or infertility associated with elevated FSH levels before the age of 40 with no known cause
  • Individuals with late onset intention tremor and/or cerebellar ataxia of unknown origin

Specimen

  
EDTA whole blood
  
  
10 mL
  

Immediately after collection, mix tube thoroughly by gentle inversion, 8 - 10 times, to prevent clotting

  

Lavender (EDTA), 10mL

  
ACD whole blood
  

Yellow ACD (A or B)

 

  

Yellow ACD (A or B)

  

Molecular Medicare billing request

Hospital clients submitting a request for this assay on an outpatient with Medicare should complete and submit a Molecular Medical billing request form along with the sample.

  • Complete and submit the form to notify us of the need for Allina Health Laboratory to bill insurance for Molecular testing performed
  • All information requested is required in order for your request to be completed
  

Ambient

  
  • Frozen specimen
  • Hemolysis
  • Quantity not sufficient for analysis (QNS) 
  • Improper container
  • Unlabeled or mislabeled specimen
  • PCR testing cannot be added on to a sample that has been opened and/or used for other testing. If the sample has already been used for testing, a new specimen will need to be collected.

Performance

  
LabCorp RTP (511655): R-LC
  
PCR - Daily
Southern Blot - 1x per week
  
8 - 12 days
  

Polymerase chain reaction (PCR) followed by capillary electrophoresis and Southern blot (SB) analysis.

Clinical and Interpretive info

  

An interpretive report will be provided

  

Fragile X syndrome is the leading cause of inherited intellectual disability, affecting approximately 1 in 4,000 males and 1 in 8,000 females. It is found in all ethnic groups, and can occur in families with no history of intellectual disability. Women may decide to have testing to find out if they are carriers, and therefore are at risk of having a child with Fragile X syndrome. The carrier frequency in women is approximately 1 in 260. Fragile X Test is commonly used for individuals at higher risk, including those that may be symptomatic or have a family history suggestive of Fragile X syndrome.

Billing

  
This test may require preauthorization from the insurance provider. Check the payer guidelines and, if needed, obtain the pre-authorization prior to sample collection.
  
81244
81243
  
Yes
  
Result 77202-0
  

Medical necessity

Hospital clients submitting a request for this assay on an outpatient with Medicare should complete and submit a Molecular Medical billing request form along with the sample.

  • Complete and submit the form to notify us of the need for Allina Health Laboratory to bill insurance for Molecular testing performed
  • All information requested is required in order for your request to be completed

Molecular Medicare billing request

Tracking

  
03/29/2019
  
01/23/2024
  
01/02/2024