Test ID LDALD Lysosomal and Peroxisomal Disorders Newborn Screen, Blood Spot
Useful For
First-tier newborn screen for the lysosomal disorders: Fabry, Gaucher, Krabbe, mucopolysaccharidosis I (MPS I) and II (MPS II), infantile neurovisceral or chronic visceral acid sphingomyelinase deficiency, and Pompe (glycogen storage disorder type II)
First-tier newborn screen for the peroxisomal disorder, X-linked adrenoleukodystrophy and may also detect Zellweger spectrum disorders
This test is supplemental and not intended to replace state-mandated newborn screening.
Test is not intended for metabolic screening of symptomatic patients.
Testing Algorithm
First-tier results will be reviewed, and second-tier screening performed at a clinical biochemical geneticist's discretion at no additional charge. This minimizes the false-positive rate and maximizes the positive predictive value of screening for these lysosomal disorders.
The following algorithms are available:
-Newborn Screen Follow-up for Acid Sphingomyelinase Deficiency
-Newborn Screen Follow-up for Gaucher Disease
-Newborn Screen Follow-up for Mucopolysaccharidosis Type I
-Newborn Screen Follow-up for Pompe Disease
-Newborn Screen Follow-up for X-Linked Adrenoleukodystrophy
-Newborn Screening Follow up for Mucopolysaccharidosis type II
If the patient has abnormal newborn screening results for X-linked adrenoleukodystrophy or a lysosomal disorder, immediate actions should be taken. Refer to the appropriate American College of Medical Genetics and Genomics Newborn Screening ACT Sheet.(1)
Method Name
Flow Injection Analysis Tandem Mass Spectrometry (FIA-MS/MS)
Reporting Name
LSD/X-ALD Newborn Screen, BSSpecimen Type
Whole bloodOrdering Guidance
Testing performed in the context of newborn screening only. For diagnostic testing or at a clinical biochemical geneticist's discretion, testing may be changed to PLSD / Lysosomal and Peroxisomal Disorders Screen, Blood Spot.
Necessary Information
Birth weight, time of birth, and gestational age are required.
Specimen Required
Patient must be older than 24 hours and younger than 1 week of age.
Supplies: Card-Blood Spot Collection (Filter Paper) (T493)
Container/Tube:
Preferred: Blood Spot Collection Card
Acceptable: PerkinElmer 226 filter paper, Munktell filter paper, Whatman Protein Saver 903 Paper, local newborn screening card, or blood collected in tubes containing ACD, or EDTA and then spotted and dried on filter paper
Specimen Volume: 2 Blood spots
Collection Instructions:
1. Completely fill at least 2 circles on the filter paper card (approximately 100 microliters blood per circle).
2. Let blood dry on the filter paper at ambient temperature in a horizontal position for a minimum of 3 hours.
3. Do not expose specimen to heat or direct sunlight.
4. Do not stack wet specimens.
5. Keep specimen dry.
Additional Information:
1. For collection instructions, see Blood Spot Collection Instructions
2. For collection instructions in Spanish, see Blood Spot Collection Card-Spanish Instructions (T777)
3. For collection instructions in Chinese, see Blood Spot Collection Card-Chinese Instructions (T800
Specimen Minimum Volume
1 Blood spot
Specimen Stability Information
Specimen Type | Temperature | Time | Special Container |
---|---|---|---|
Whole blood | Refrigerated (preferred) | 90 days | FILTER PAPER |
Frozen | 90 days | FILTER PAPER | |
Ambient | 28 days | FILTER PAPER |
Reference Values
An interpretive report will be provided.
Day(s) Performed
Monday through Sunday
Report Available
2 daysPerforming Laboratory
Mayo Clinic Laboratories in RochesterTest Classification
This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. It has not been cleared or approved by the US Food and Drug Administration.CPT Code Information
83789
LOINC Code Information
Test ID | Test Order Name | Order LOINC Value |
---|---|---|
LDALD | LSD/X-ALD Newborn Screen, BS | 85267-3 |
Result ID | Test Result Name | Result LOINC Value |
---|---|---|
38521 | LSD/X-ALD Newborn Screen Result | 85268-1 |
38520 | Reviewed By | 18771-6 |
BG684 | Birth Weight (grams, XXXX) | 8339-4 |
BG685 | Time of Birth (24hr Time, XX:XX) | 57715-5 |
BG686 | Gestational Age (weeks, XX.X) | 76516-4 |
NY State Approved
YesGenetics Test Information
Lysosomal disorders are a diverse group of inherited diseases characterized by the intracellular accumulation of macromolecules leading to cell damage and organ dysfunction.
Peroxisomal disorders, such as X-linked adrenoleukodystrophy are caused by a defect in a single peroxisomal enzyme/transporter, whereas Zellweger spectrum disorders are caused by peroxisome biogenesis defects.
Due to the improved outcomes associated with presymptomatic intervention, some states have recently added select lysosomal disorders and peroxisomal disorders to their newborn screening programs.
Additional biochemical or molecular testing is required to confirm a diagnosis if enzyme deficiency is detected by this screening test.
Forms
1. Biochemical Genetics Patient Information (T602)
2. If not ordering electronically, complete, print, and send 1 of the following with the specimen.
-Biochemical Genetics Test Request (T798)
-General Test Request (T239)
Special Instructions
- Biochemical Genetics Patient Information
- Blood Spot Collection Card-Spanish Instructions
- Newborn Screen Follow-up for X-Linked Adrenoleukodystrophy
- Newborn Screen Follow-up for Pompe Disease
- Newborn Screen Follow-up for Mucopolysaccharidosis Type I
- Newborn Screen Follow-up for Gaucher Disease
- Blood Spot Collection Card-Chinese Instructions
- Blood Spot Collection Instructions
- Newborn Screen Follow-up for Acid Sphingomyelinase Deficiency
- Newborn Screening Follow-up for Mucopolysaccharidosis type II