Special Communication: Changes to MALIGG, FLT3MD, FLUOX, EHISTO, PBALIN, and CKISO Tests

FLT3 Mutation Detection by PCR (FLT3MD)

Effective 2/6/17, FLT3 Mutation Detection by PCR (FLT3MD) will include the following changes:

Special Information
Must indicate specimen type. Unacceptable conditions: Grossly hemolyzed or clotted specimens.

This test is New York DOH approved.

Specimen Requirement
The primary specimen will still be 5 mL whole blood in an EDTA lavender tube; however, the minimum volume will increase to 5 mL. Minimum volumes will increase for the alternate samples as well. The alternate samples include 5 mL whole blood in a sodium or lithium heparin green top tube OR ACD A or B (yellow) tube; Minimum volume 5 mL, 3 mL bone marrow in an ACD A or B (yellow) tube OR EDTA lavender tube OR sodium or lithium heparin green top tube; Minimum volume 3 mL. Also acceptable is 1 µg extracted DNA; Minimum volume 1 µg. Transport temperature is refrigerated.

Stability
Ambient: 72 hours
Refrigerated: 1 week for blood and bone marrow; indefinitely for extracted DNA
Frozen: Unacceptable

Days Performed and Reported
Days performed varies; reporting time will be 5 – 12 days.

CPT
81245 x 1, 81246 x 1

Fluoxetine/Norfluoxetine (FLOUX)

Effective 2/6/17, Fluoxetine/Norfluoxetine (FLUOX) will include the following changes:

Special Information
Unacceptable conditions: Separator tubes.

This test is New York DOH approved.

Clinical Information
Optimize drug therapy and monitor patient adherence.

Specimen Requirement
Specimen volume requirements are increasing for this test. The primary specimen will be 3 mL serum from a red top tube with no additive; Minimum volume 1.2 mL. Draw 2 tubes to ensure adequate specimen volume. Do not use serum separator tubes. Separate serum from cells ASAP or within 2 hours of collection and transfer to aliquot tube.

The alternate specimen will be 3 mL plasma from an EDTA lavender top tube; Minimum volume 1.2 mL. Draw 2 tubes to ensure adequate specimen volume. Do not use plasma separator tubes. Separate plasma from cells ASAP or within 2 hours of collection and transfer to aliquot tube.

Stability
Ambient: 1 week
Refrigerated: 2 weeks
Frozen: 18 months

Methodology
Gas Chromatography Mass Spectrometry (GCMS)

Reference Range
Fluoxetine: Refer to report
Norfluoxetine: Refer to report

Days Performed and Reported
Days performed varies; reporting time will be 5 – 12 days.

Entamoeba histolytica, IgG (EHISTO)

Effective 2/6/17, Entamoeba histolytica, IgG (EHISTO) will include the following changes:

Special Information
Acute and convalescent specimens must be labeled as such; parallel testing is preferred and convalescent specimens MUST be received within 30 days from receipt of the acute specimens. Unacceptable conditions: Contaminated, heat-inactivated, hemolyzed or severely lipemic specimens.

This test is New York DOH approved.

Clinical Information
Aid in the detection of amebic liver abscess. Test is not useful for intestinal infection. In case of extraintestinal complications, a positive antibody can indicate amebiasis even though stool findings are negative. Seroconversion between acute and convalescent sera is considered strong evidence of recent infection. The best evidence for infection is a significant change on two appropriately timed specimens where both tests are done in the same laboratory at the same time.

Specimen Requirement
The primary specimen will still be 1 mL serum from a serum separator (gold) tube. The minimum volume is decreasing to 0.1 mL. Separate serum from cells ASAP or within 2 hours of collection. Please mark specimen plainly as ACUTE or CONVALESCENT. Transport temperature is refrigerated.

Reference Range
Negative (No significant level of detectable E. histolytica IgG Antibody): 8 U or less
Equivocal (Repeat testing in 10-14 days may be helpful): 9 – 11 U
Positive (Current or past infection): 12 U or greater

Pregabalin (PBALIN)

Effective 3/1/2017, Pregabalin (PBALIN) will include the following changes:

Special Information
This test is New York State approved.

Specimen Requirement
The primary specimen will still be 1 mL serum from a red top tube with no additive. The minimum volume requirement will decrease to 0.5 mL. Draw specimen immediately before next scheduled dose. Centrifuge within 2 hours of draw and transfer to plastic vial. Do not use serum separator tubes.

Stability
Ambient: 28 days
Refrigerated: 28 days
Frozen: 28 days

Reference Range
2.0 – 5.0 mcg/mL

Days Performed and Reported
Performed daily; reporting time will be 2 – 3 days.

CK Isoenzymes (CKISO)

Effective 3/6/2017, CK Isoenzymes (CKISO) will include the following changes:

Includes
% CKBB
% CKMB
% CKMM
Creatine Kinase, Total
Interpretation

Special Information
Hemolyzed specimens will be rejected. Specimens received thawed will be rejected. CK-MB and CK-BB are temperature labile. Repeated freeze/thaw cycles destroy CK activity. If CK and CK Isoenzymes are ordered together, specimen must be submitted frozen.

Specimen Requirement
The primary specimen will still be 2 mL serum in a serum separator (gold) tube. Minimum volume is 1 mL. The change is the removal of the alternate specimen, a red top tube with no additive.

Stability
Ambient: Unacceptable
Refrigerated: 48 hours
Frozen: 14 Days