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August 2021: Changes to Specimen Requirements, Reference Ranges, and Test Builds

Special Communication

August 2021: Changes to Specimen Requirements, Reference Ranges, and Test Builds

All changes effective August 16, 2021.

Changes to Specimen Requirements

Allergen, Food, Alpha-Gal IgE (GALIGE)

Specimen Requirements

Specimen Type:
Serum

Volume:
0.25 mL

Minimum Volume:
0.25 mL

Collection Container:
Gold Serum Separation Tube (SST)

Transport Temperature:
Refrigerated

Additional Information:
Separate serum from cells ASAP or within 2 hours of collection.

Macroprolactin (MACPRO)

Specimen Requirements

Specimen Type:
Serum

Volume:
1 mL

Minimum Volume:
0.5 mL

Collection Container:
Gold Serum Separation Tube (SST)

Transport Temperature:
Frozen

Additional Information:
Allow specimen to clot completely at room temperature. Separate serum from cells and transfer into a standard aliquot tube.

Alternative Specimen Requirements

Specimen Type:
Plasma

Volume:
1 mL

Minimum Volume:
0.5 mL

Collection Container:
Lavender K2EDTA Tube or Light Green Lithium Heparin Plasma Separator Tube (PST)

Transport Temperature:
Frozen

Additional Information:
Separate plasma from cells and transfer into a standard aliquot tube.

Prolactin, Dilution Study (PROLM)

Specimen Requirements

Specimen Type:
Serum

Volume:
1 mL

Minimum Volume:
1 mL

Collection Container:
Gold Serum Separation Tube (SST)

Transport Temperature:
Frozen

Additional Information:
Allow specimen to clot completely at room temperature. Separate serum from cells and transfer into a standard aliquot tube.

Alternative Specimen Requirements

Specimen Type:
Plasma

Volume:
1 mL

Minimum Volume:
1 mL

Collection Container:
Lavender K2EDTA Tube or Light Green Lithium Heparin Plasma Separator Tube (PST)

Transport Temperature:
Frozen

Additional Information:
Separate plasma from cells and transfer into a standard aliquot tube.

Changes to Reference Ranges

Allergen, Food, Alpha-Gal IgE (GALIGE)

Less than 0.10:
No significant level detected (Class Score 0)

0.10-0.34:
Clinical relevance undetermined (Class Score 0/1)

0.35-0.70:
Low (Class Score 1)

0.71-3.50:
Moderate (Class Score 2)

3.51-17.50:
High (Class Score 3)

17.51-50.00:
Very high (Class Score 4)

50.01-100.00:
Very high (Class Score 5)

Greater than 100.00:
Very high (Class Score 6)

IBD Serology Disease Panel (IBDSER)

Saccharomyces cerevisiae Antibody, IgA

20.0 Units or less:
Negative

20.1-24.9 Units:
Equivocal

25.0 Units or greater:
Positive

Saccharomyces cerevisiae Antibody, IgG

20.0 Units or less:
Negative

20.1-24.9 Units:
Equivocal

25.0 Units or greater:
Positive

ANCA IFA Titer

Less than 1:20

ANCA IFA Pattern

None detected

Macroprolactin (MACPRO)

Prolactin

Male
2.1-17.7 ng/mL

Female, 1-9 years
2.1-17.7 ng/mL

Female, 10 years and older
2.8-29.2 ng/mL

Monomeric, Prolactin

Male
2.1-13.3 ng/mL

Female, 1-9 years
2.1-13.3 ng/mL

Female, 10 years and older
2.8-19.5 ng/mL

Percent
Greater than 50%

Oxalate (OXLATE)

Normal
< or = 2.0 umol/L

Prolactin, Dilution Study (PROLM)

Prolactin

Male
2.1-17.7 ng/mL

Nonpregnant Female, 1-9 years
2.1-17.7 ng/mL

Nonpregnant Female, 10 years and older
2.8-29.2 ng/mL

Nicotine & Metabolites, Urine (UNICOT)

Nicotine
15 ng/mL

Cotinine (metabolite)
15 ng/mL

3-OH-Cotinine (metabolite)
50 ng/mL

Anabasine (tobacco biomarker)
5 ng/mL

Changes to Test Build

Allergen, Food, Alpha-Gal IgE (GALIGE)

Components Affected

Allergen, Food, Alpha-Gal IgE

Reflex: Allergen Interp, Immunocap Score IgE

IBD Serology Disease Panel (IBDSER)

Components Affected

S. cerevisiae Antibody, IgA

S. cerevisiae Antibody, IgG

Inflammatory Bowel Disease Interp

ANCA IFA Titer

ANCA IFA Pattern

EER Inflammatory Bowel Diseases

Nicotine & Metabolites, Urine (UNICOT)

Components Affected

Remove Nornicotine, Urine

Test Discontinuations

HIV-1 Genotype (HIVGEN)

Reason for Discontinuation:
No longer offered by the vendor

Alternative Test:
HIV 1 Drug Resistance by Next Generation Sequencing (HIVNGS)

Anti-Neut Cyto Ab with Reflex to Titer and MPO/PR3 Ab (NCYTO)

Reason for Discontinuation:
No longer offered by the vendor

Alternative Test:
Neutrophil Cytoplasmic Antibody (ANCA)

Any additional information will be included in a future Technical Update.  If you have any questions about these changes, please contact Client Services for assistance.