Category: Immediate Test Changes

March 2019: Changes to PR1433, GM1BM, OMEGAC

Immediate Test Changes

Changes to 14-3-3 Protein, CSF (PR1433), Ganglioside Antibody Panel (GM1BM), and OmegaCheck (OMEGAC)

14-3-3 Protein, CSF (PR1433)

Effective March 22, 2019.

Effective immediately, 14-3-3 Protein, CSF (PR1433) is discontinued with no recommended replacement.

The performing laboratory is evaluating new reagents; if these are found to be acceptable, this test may be reactivated in the future.

Ganglioside Antibody Panel (GM1BM)

Effective April 18, 2019.

Ganglioside Antibody Panel (GM1BM) will be discontinued on April 18, 2019.

We suggest ordering Ganglioside Antibodies (GANGAB).

OmegaCheck (OMEGA)

Effective April 22, 2019.

Changes to Reference Ranges

OmegaCheck:
> 5.4% by wt

Arachidonic Acid/EPA Ratio:
3.7 – 40.7

Omega-6/3 Ratio:
3.7 – 14.4

EPA:
0.2 – 2.3% by wt

DPA:
0.8 – 1.8% by wt

DHA:
1.4 – 5.1% by wt

Arachidonic Acid:
8.6 – 15.6% by wt

Linoleic Acid:
18.6 – 29.5% by wt

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.

Special Communications
Immediate Test Changes
News & Updates

March 2019: Changes to Acceptable Clobazam (CLOBAZ) Specimen Types

Immediate Test Changes

Changes to Acceptable Clobazam (CLOBAZ) Specimen Types

Effective March 6, 2019.

Specimen Requirements

Volume:
0.5 mL, serum

Minimum Volume:
0.35 mL, serum

Collection Container:
Red BD Hemogard™ Serum Tube (No Additive)

Plasma is no longer an acceptable specimen type.
Serum from a gel tube remains unacceptable.

Specimen Instructions:
Draw specimen immediately before the next scheduled dose. Trough specimens are recommended, as therapeutic ranges are based on trough collections.

Centrifuge the specimen within two hours of collection, transfer the serum into a standard plastic aliquot tube, and transport refrigerated.

Transport Temperature:
Refrigerated

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.

Special Communications
Immediate Test Changes
News & Updates

March 2019: Changes to IgG Subclass Reference Ranges

Immediate Test Changes

Changes to IgG Subclass Reference Ranges

Effective March 2, 2019.

IgG Subclass Testing

• IgG Subclass 4 (IGG4)

• IgG Subclasses (IGGSUB)

• IgG Subclasses 1, 2, 3, 4 (IG1234)

Reference Ranges

IgG Subclass 1
10 – 12 Years:  423.0 – 1060.0 mg/dL

IgG Subclass 4:
6 – 8 Years:  0.4 – 99.2 mg/dL

All other reference ranges will remain the same.

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 or email Kamran Kadkhoda, PhD, D(ABMLI) with medical questions.

Special Communications
Immediate Test Changes
News & Updates

November 2018: Changes to Melatonin (MELAT) Testing

Immediate Test Changes

Changes to Melatonin (MELAT) Testing

Effective November 14, 2018.

Specimen Requirements
• 3 mL plasma in a Lavender BD Hemogard™ K2EDTA Tube
Note: Draw two tubes to ensure adequate volume.

• Minimum volume: 1 mL

Specimen Collection
• Patient Preparation: Fasting specimen preferred.

Centrifuge the tubes, then transfer plasma into a standard aliquot tube before freezing the specimen.

Transportation
• Transport Temperature: Frozen

Additional Information
Melatonin concentration varies with light and dark cycles: concentration is lower during the day and higher at night.Patients treated with pituitary or steroid hormones influence the concentration.  Hormones should be discontinued for two days prior to collection.

Alternative Specimen Types
• 3 mL serum in a Gold BD Hemogard™ Serum Separation Tube (SST)™

• 3 mL serum in a Red BD Hemogard™ Serum Tube (No Additive)

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.

Special Communications
Immediate Test Changes
News & Updates

October 2018: Changes to ASPIGG, GAL3, HV6ABS, LIDO, & PROPA Testing

Special Communication

Changes to ASPIGG, GAL3, HV6ABS, LIDO, & PROPA Testing

Effective November 12, 2018.

Aspergillus fumigatus Antibody IgG (ASPIGG)

Previously Aspergillus fumigatus Antibody, IgG by ELISA

Volume:
0.5 mL, serum

Minimum Volume:
0.2 mL

Specimen Container:
Gold BD Hemogard™ Serum Separation Tubes (SST)™

Galectin-3 (GAL3)

Volume:
1 mL, serum

Specimen Container:
Red BD Hemogard™ Serum Tube (No Additive)

Do not draw Gold Serum Separation Tube (SST) tubes.

Propafenone (PROPA)

Volume:
2 mL, serum

Minimum Volume:
0.7 mL

Specimen Container:
Red BD Hemogard™ Serum Tube (No Additive)

Volume (Alternative):
2 mL, plasma

Minimum Volume:
0.7 mL

Alternative Specimen Container:
Lavender BD Hemogard™ K2EDTA Tube

Effective November 26, 2018.

Herpesvirus 6 Human IgG & IgM Abs (HV6ABS)

Volume:
0.5 mL, serum

Specimen Container:
Red BD Hemogard™ Serum Tube (No Additive)

Transport Temperature:
Ambient (room temperature)

Effective November 27, 2018.

Lidocaine (LIDO)

Volume:
1 mL, plasma

Specimen Container:
Green Sodium Heparin or Lithium Heparin Tube

Volume (Alternative):
1 mL, serum

Alternative Specimen Container:
Red BD Hemogard™ Serum Tube (No Additive)

Effective November 12, 2018.

Reference Range Changes

• Arsenic, Blood (ASB)
• Aspergillus fumigatus Antibody IgG (ASPIGG)
• Eosinophil Cationic Protein (EOSPRO)
• Heavy Metals Screen, Whole Blood (HEVMET)
• Heavy Metals, Urine (UTXM3)
• Heavy Metals with Cadmium, Urine (UTXM4)
• Heavy Metals with Cadmium, Whole Blood (HEVMT4)

• Lead, Urine 24 Hour (ULEADQ)
• Mercury, Blood (MERC2)
• Mercury, Urine 24 Hour (UMERC3)
• Mexiletine (MEX)
• Propafenone (PROPA)*
• Sotalol (SOTAL)*
• Thallium, Urine (UTHAL)

Additional reference range changes:

October 22, 2018
Galactose-alpha-1,3-galactose IgE (13GAL)

November 26, 2018
Herpesvirus 6 Human IgG & IgM Abs* (HV6ABS)

November 27, 2018
Lidocaine (LIDO)

Interfaced clients may need to adjust the test build for Herpesvirus 6 Human IgG & IgM Abs (HV6ABS), Propafenone (PROPA), and Sotalol (SOTAL).

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.

Special Communications
Immediate Test Changes
News & Updates

Heparin Anti Xa Assay (HEPASY), PTT Incubated Mixing Study (PTTIM)

Immediate Test Change

Changes to Heparin Anti-Xa Assay (HEPASY) and PTT Incubated Mixing Study (PTTIM)

Heparin Anti Xa Assay (HEPASY)

Effective February 22, 2018

Specimen Requirements

Volume:
1 mL, platelet-poor plasma

Minimum Volume:
0.5 mL, platelet-poor plasma

Collection Container:
Light Blue Sodium Citrate Coagulation Tube

Stability

Ambient:
Centrifuge within one hour of phlebotomy and test; or freeze platelet-poor plasma within 4 hours

Refrigerated:
Unacceptable

Frozen:
2 weeks at minus 20°C
6 months at minus 70°C

Reference Range

0 – 99 Years:
Therapeutic range: 0.3 – 0.7 (standard nomogram) IU/mL

0 – 99 Years:
< 0.10 IU/mL

0 – 99 Years:
Stroke or low dose protocol: 0.2 – 0.5 IU/mL

Partial Thrombin Time (PTT) Incubated Mixing Study (PTTIM)

Effective February 22, 2018

Reference Ranges

PT + APPT Screen

PT Screen

0 – 1 Days:
7.9 – 14.8 sec

2 – 5 Days:
7.4 – 14.2 sec

6 – 30 Days:
7.2 – 13.3 sec

1 – 3 Months:
7.2 – 13.2 sec

4 – 11 Months:
8.3 – 12.9 sec

1 – 99 Years:
8.4 – 13.0 sec

APPT Screen

0 – 1 Days:
28.7 – 45.1 sec

2 – 5 Days:
23.3 – 49.4 sec

6 – 30 Days:
23.5 – 45.6 sec

1 – 3 Months:
22.1 – 41.4 sec

4 – 11 Months:
25.8 – 35.5 sec

1 – 99 Years:
24.4 – 33.4 sec

Immediate + Incubated PTT

Immediate PTT, 1:1 Mix

0 – 99 Years:
< 30.9 sec

Incubated PTT, 1:1 Mix

0 – 99 Years:
< 33.6 sec

Thrombin Time

Thrombin Time

0 – 1 Days:
< 17.4 sec

2 – 5 Days:
< 17.9 sec

6 – 30 Days:
< 17.9 sec

1 – 3 Months:
< 18.2 sec

4 – 11 Months:
< 19.1 sec

1 – 99 Years:
< 18.6 sec

Heparin Anti Xa

Heparin Anti Xa

0 – 99 Years:
Therapeutic range: 0.3 – 0.7 (standard nomogram) IU/mL

0 – 99 Years:
< 0.10 IU/mL

0 – 99 Years:
Stroke or low dose protocol: 0.2 – 0.5 IU/mL

If you have any questions about these changes, please contact Client Services for assistance.

Immediate Test Changes
Special Communications
News & Updates

FLT3 Mutation Detection by PCR (FLT3MD)

Immediate Test Change

FLT3 Mutation Detection by PCR (FLT3MD)

Effective February 5, 2018.

New Specimen Requirements

Volume:
3 mL, whole blood; or
1 mL, bone marrow

Minimum Volume:
1 mL, whole blood; or
0.25 mL, bone marrow

Collection Container:
Green BD Hemogard™ Sodium Heparin Tubes

Specimens submitted in a lithium heparin (green) tube are no longer acceptable for FLT3MD Testing.

 

If you have any questions about this change, please contact Client Services for assistance.

Immediate Test Changes
Special Communications
News & Updates

Chromogranin A (CHROMA)

Immediate Test Change

Chromogranin A (CHROMA)

Effective September 12, 2017.

Due to a reagent shortage, Chromogranin A testing was recently discontinued by our current vendor.

This situation requires our laboratories to change to a laboratory using a different assay.

Because Chromogranin A assays are not standardized to a common reference material, the numerical values reported by different assays can vary significantly, and results from different methods or kits cannot be used interchangeably.

Based on historical data, the results from the new assay will be substantially higher than seen with the previous test, which is reflected in the higher reference range of the new assay.

<

If you have any questions about this change, please contact Client Services for assistance.

Immediate Test Changes
Special Communications
News & Updates