September 2019: Changes to Lp-PLA2 Activity Reference Ranges

Special Communication

Changes to Lp-PLA2 Activity Reference Ranges

Changes to Reference Ranges

Effective September 16, 2019.

Lp-PLA2 Activity (PLAA2)

Goal (Optimum)

0 – 99 Years:
≤ 123 nmol/min/mL

High-Risk

0 – 99 Years:
> 123 nmol/min/mL

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.

August 2019: Changes to PARNEO, FTESTO Testing

Special Communication

Changes to Paraneoplastic Autoantibody Evaluation, Serum (PARNEO) and  Testosterone, Free and Total (FTESTO) Testing

Changes to Test Build

Paraneoplastic Autoantibody Evaluation, Serum (PARNEO)

Effective September 5, 2019.

Interfaced Clients: These updates may require changes to the Test Build.

Test Discontinuation

Testosterone, Free and Total (FTESTO)

Effective August 29, 2019.

FTESTO will be made obsolete on August 29, 2019.

This test will be replaced with Testosterone, Total and Free, Serum (TFTEST).  Learn more about this test discontinuation.

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.

July 2019: Changes to NCYTO, URCAT2, MYOSPL, RUFIN, LIVFIB, & AJPWO Testing

Special Communication

Changes to NCYTO, URCAT2, MYOSPL, RUFIN, LIVFIB, & AJPWO Testing

Changes to Reference Ranges

Effective August 19, 2019.

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

Charting Name Change

Serine Protease 3, IgG will change to Serine Proteinase 3, IgG.

Effective August 19, 2019.

Catecholamines Fractionated by LC-MS/MS, Urine Free (URCAT2)

Reference Ranges: Epinephrine, Urine per 24h

0 – 3 Years:
Not Established

4 – 10 Years:
1 – 14 µg/d

11 – 17 Years:
1 – 18 µg/d

18 – 99 Years:
1 – 14 µg/d

Effective August 19, 2019.

Polymyositis and Dermatomyositis Panel (MYOSPL)

Reference Ranges:

Jo-1 Antibody, IgG

Negative:
29 AU/mL or less

Equivocal:
30 – 40 AU/mL

Positive:
41 AU/mL or greater

PL-7 (threonyl-tRNA synthetase) Antibody:
Negative

PL-12 (alanyl-tRNA synthetase) Antibody:
Negative

EJ (glycyl-tRNA synthetase) Antibody:
Negative

SRP (Signal Recognition Particle) Ab:
Negative

OJ (isoleucyl-tRNA synthetase) Antibody:
Negative

Mi-2 (nuclear helicase protein) Antibody:
Negative

P155/140 Antibody:
Negative

SAE1 (SUMO activating enzyme) Antibody:
Negative

MDA5 (CADM-140) Antibody:
Negative

NXP-2 (Nuclear matrix protein-2) Antibody:
Negative

TIF-1 gamma (155 kDa) Antibody:
Negative

Effective August 19, 2019.

Rufinamide (RUFIN)

Reference Ranges:

Therapeutic Range:
5 – 30 µg/mL

Dose-Related Range (values at dosages of 800 – 7200 mg/day):
3 – 30 µg/mL

Effective September 23, 2019.

Liver Fibrosis, FibroTest-ActiTest (LIVFIB)

Reference Ranges: Fibrosis Interpretation

No fibrosis
FibroTest Score: ≥ 0 and ≤ 0.21
Metavir Score: F0

No fibrosis
FibroTest Score: > 0.21 and ≤ 0.27
Metavir Score: F0 – F1

Minimal fibrosis
FibroTest Score: > 0.27 and ≤ 0.31
Metavir Score: F1

Minimal fibrosis
FibroTest Score: > 0.31 and ≤ 0.48
Metavir Score: F1 – F2

Moderate fibrosis
FibroTest Score: > 0.48 and ≤ 0.58
Metavir Score: F2

Advanced fibrosis
FibroTest Score: > 0.58 and ≤ 0.72
Metavir Score: F3

Advanced fibrosis
FibroTest Score: > 0.72 and ≤ 0.74
Metavir Score: F3 – F4

Severe fibrosis
FibroTest Score: > 0.74 and ≤ 1.00
Metavir Score: F4

Reference Ranges: Necroinflammatory Activity Interpretation

No activity
ActiTest Score: ≥ 0 and ≤ 0.17
Metavir Score: A0

No activity
ActiTest Score: > 0.17 and ≤ 0.29
Metavir Score: A0 – A1

Minimal activity
ActiTest Score: > 0.29 and ≤ 0.36
Metavir Score: A1

Minimal activity
ActiTest Score: > 0.36 and ≤ 0.52
Metavir Score: A1 – A2

Significant activity
ActiTest Score: > 0.52 and ≤ 0.60
Metavir Score: A2

Significant activity
ActiTest Score: > 0.60 and ≤ 0.62
Metavir Score: A2 – A3

Severe activity
ActiTest Score: > 0.62 and ≤ 1.00
Metavir Score: A3

Changes to Test Build

Ashkenazi Jewish Diseases (AJPWO)

Effective August 19, 2019.

Interfaced Clients: These updates may require changes to the Test Build.

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.

June 2019: Changes to UALDOS, TSIG, TRAB

Special Communication

Changes to Aldosterone with Na and K, 24hr Urine (UALDOS), Thyroid Stimulating Immunoglobulin (TSIG), and TSH Receptor Antibody (TRAB) Testing

Changes to Specimen Requirements

Effective May 20, 2019.

Specimen Requirements:

Aldosterone with Na and K, 24-hr Urine (UALDOS)

Volume:
1 mL, 24-hour urine

Minimum Volume:
0.5 mL

Collection Container:
Clean container

Transport Temperature:
Refrigerated

Samples with additives will be rejected.

Changes to Reference Ranges

Effective August 28, 2019.

Interfaced Clients: These updates may require changes to the Test Build.

Reference Ranges:

Thyroid Stimulating Immunoglobulin (TSIG)

Thyroid Stimulating Immunoglobulin:
< 0.55 IU/L

Thyroid Stimulating Immunoglobulin, Qualitative:
Negative

Reference Ranges:

TSH Receptor Antibody (TRAB)

Thyroid Stimulating Immunoglobulin:
< 0.55 IU/L

Thyroid Stimulating Immunoglobulin, Qualitative:
Negative

TSH Binding Inhibition (0 – 99 Years):
< 1.0 U/L

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.

May 2019: Changes to Reference Ranges & Test Builds

Special Communication

May 2019: Changes to Reference Ranges & Test Builds

Changes to Reference Ranges

Effective May 21, 2019.

Reference Ranges:

Cysticercus IgG Ab, Serum (CYSGBL)

≤ 0.8 IV:
Negative
No significant level of cysticercosis IgG antibody detected

0.9 – 1.1 IV:
Equivocal
Questionable presence of cysticercosis IgG antibody detected; repeat testing in 10-14 days may be helpful

≥ 1.2 IV:
Positive
IgG antibodies to cysticercosis detected, which may suggest current or past infection

Effective June 3, 2019.

Reference Ranges:

Liver Fibrosis, FibroTest-ActiTest (LIVFIB)

Apolipoprotein A1

Male:
≥ 115 mg/dL

Female:
≥ 125 mg/dL

Effective June 4, 2019.

Reference Ranges:

Galactose Quant, Plasma (GALAC)

≤ 7 days:
< 5.4 mg/dL

8 – 14 days:
< 3.6 mg/dL

≥ 15 days:
< 2.0 mg/dL

Effective July 2, 2019.

Reference Ranges:

Hemoglobin, A2 (HBA2)

Reference Range
2.0 – 3.1%

Effective July 2, 2019.

Reference Ranges:

Hemoglobin, A2 and F (A2F)

Hemoglobin Fetal:
0.0 – 0.9%

Hemoglobin A2 Percent:
2.0 – 3.1%

Effective July 2, 2019.

Reference Ranges:

Hemoglobin, Fetal (HBF)

Reference Range
0.0 – 0.9%

Effective July 9, 2019.

Reference Ranges:

Vancomycin (VANCRA)

0 – 99 Years:
10.0 – 20.0 µg/mL

Test Build Changes

These updates may require changes to the Test Build for interfaced clients.

Spinal Muscular Atrophy Carrier Screening and Diagnostic (SMAGEN)

Effective May 30, 2019.

Paraneoplastic Autoantibody Evaluation, CSF (PARCSF)

Effective June 11, 2019.

Discontinued Tests

Effective May 21, 2019.

Degradation Products (FDP)

Due to the lack of availability of the appropriate tubes, this test has been discontinued.

We suggest ordering D-Dimer (DDMER).

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.

May 2019: Upcoming Test Changes, Updates, and Discontinuations

Special Communication

May 2019: Upcoming Test Changes, Updates, and Discontinuations

Changes to Reference Ranges

Effective April 24, 2019.

Trypsinogen (TRYPSI)

0 – 17 Years:
Not established

18 Years & Older:
180.5 – 885.3 ng/mL

Changes to Specimen Requirements

Effective May 20, 2019.

Drug Detection Panel, TOF-MS, Umbilical Cord Tissue (DRGTOF)

Volume:
8 inches of umbilical cord (approximately the width of a sheet of paper)

Minimum Volume:
6 inches

Collection Instructions:
Drain and discard any blood. Rinse the exterior of the cord segment with normal saline or water. Pat the cord dry and transport the specimen in a routine urine collection cup or use a Security Kit for Meconium/Umbilical Drug Detection.

Transport Temperature:
Refrigerated

Reference Range:
Gabapentin: Cut-off 10 ng/g

Buprenorphine-G will be removed; all other reference ranges will remain the same.

Drug Detection Panel, Umbilical Cord Tissue, with Marijuana Metabolite (DTOFMP)

Volume:
8 inches of umbilical cord (approximately the width of a sheet of paper)

Minimum Volume:
8 inches

Collection Instructions:
Drain and discard any blood. Rinse the exterior of the cord segment with normal saline or water. Pat the cord dry and transport the specimen in a routine urine collection cup or use a Security Kit for Meconium/Umbilical Drug Detection.

Transport Temperature:
Refrigerated

Reference Range:
Gabapentin: Cut-off 10 ng/g

Buprenorphine-G will be removed; all other reference ranges will remain the same.

Marijuana Metabolite, Umbilical Cord Tissue, Qualitative (DRGTHC)

Volume:
8 inches of umbilical cord (approximately the width of a sheet of paper)

Minimum Volume:
6 inches

Collection Instructions:
Drain and discard any blood. Rinse the exterior of the cord segment with normal saline or water. Pat the cord dry and transport the specimen in a routine urine collection cup or use a Security Kit for Meconium/Umbilical Drug Detection.

Transport Temperature:
Refrigerated

Test Build Changes

These updates may require changes to the Test Build for interfaced clients.

Effective May 20, 2019.

Disopyramide (Norpace) (DISOP)

Drug Detection Panel, TOF-MS, Umbilical Cord Tissue (DRGTOF)

Drug Detection Panel, Umbilical Cord Tissue, with Marijuana Metabolite (DTOFMP)

Ethosuximide (ETHOS)

Discontinued Tests

Effective May 20, 2019.

5-Fluorouracil Toxicity, Chemo Response, 5 Mut (5FLUO)
We suggest ordering Dihydropyrimidine Dehydrogenase (DPYD), 3 Variants (5FUDPD).

Cytochrome P450 2D6 (CYP2D6) Geno (2D6GEN)
We suggest ordering the new test, CYP2D6 (Cytochrome P450 2D6) (2D6GTP).

Cyto P450 2C19 – 9 Variants (2C19PL)
We suggest ordering the new test, CYP2C19 (Cytochrome P450 2C19) (2C19CY).

Warfarin Sensitivity Genotyping (WARSEN)
We suggest ordering new test Warfarin Sensitivity (CYP2C8, CYP2C9, CYP4F2, VKORC1) Genotyping (WRFSEN).

Fats, Urine (UFAT)

Changes to Specimen Requirements

Effective May 29, 2019.

Complement Deficiency Assay (COMPD)

Volume:
1 mL, serum

Minimum Volume:
0.25 mL

Collection Container:
Red (Serum) No Additive Tube

Collection Instructions:
Allow sample to clot, then separate serum from cells as soon as possible. Centrifuge, then remove serum and freeze at minus 20°C or colder (up to 7 days post-draw). Minus 70 °C or colder is preferred and is acceptable up to 30 days post-draw.

Transport Temperature:
Frozen

Tryptase (TRYPT)

Reference Range:
< 8.4 µg/L

Test Build Changes

Effective June 24, 2019.

These updates may require changes to the Test Build for interfaced clients.

HIV-1 Integrase Genotype (HIVIGT)

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.

December 2018: Changes to RETAB, IA2AB, and PNHPNL Testing

Special Communication

Changes to RETAB, IA2AB, and PNHPNL Testing

Reticulin IgA and IgG Antibodies (RETAB)

Effective December 31, 2018.

Specimen Requirements

Volume:
0.8 mL, serum

Minimum Volume:
0.4 mL, serum

Collection Container:
Gold BD Hemogard™ Serum Separation Tube (SST)™

Alternate Container:
Red BD Hemogard™ Serum Tube

Specimen Instructions:
Centrifuge the specimen, then aliquot serum into a standard, non-sterile aliquot tube.

Transport Temperature:
Refrigerated

 

Insulinoma-Associated Antibody 2 (IA2AB)

Effective January 11, 2019.

Specimen Requirements

Volume:
0.5 mL, serum

Minimum Volume:
0.1 mL, serum

Collection Container:
Gold BD Hemogard™ Serum Separation Tube (SST)™

Transport Temperature:
Frozen

Stability

Ambient:
8 hours

Refrigerated:
48 hours

Frozen:
14 days

Other Information

Methodology:
Enzyme-Linked Immunosorbent Assay (ELISA)

Reference Range:
< 7.5 U/mL

Paroxysmal Nocturnal Hemoglobinuria (PNH) Panel by FCM (PNHPNL)

Effective January 15, 2019.

Stability

Ambient:
48 hours

Refrigerated:
Unacceptable

Frozen:
Unacceptable

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.

October 2018: Changes To COMPC1, COMP3A, & COMP4A Testing

Special Communication

Changes To COMPC1, COMP3A, & COMP4A Testing

Changes effective as of November 5, 2018.

Complement C 1 (COMPC1)

Separate specimens must be submitted when multiple tests are ordered.

Volume:
1 mL, serum

Minimum Volume:
0.25 mL

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

Collection Instructions:
Allow blood to clot for 20 – 60 minutes at room temperature (or 37 °C), then centrifuge.  Aliquot serum into a standard aliquot tube, then freeze the specimen immediately on dry ice or at -70 °C.

Do not draw gel separator tubes.

Transport Temperature:
Critical Frozen – send the frozen specimen via Priority Overnight in a well-insulated container on dry ice.

Thawed specimens or specimens stored at or above -20°C will not be accepted.

Reference Range
• 116,373 – 264,072 units/mL

Complement Component Level 3A (COMP3A)

Separate specimens must be submitted when multiple tests are ordered.

Volume:
1 mL, plasma

Minimum volume:
0.5 mL

Collection Container:
Lavender BD Hemogard™ K2EDTA Tube

Collection Instructions:
Mix well. Centrifuge the specimen at room temperature within 30 minutes of collection, then transfer the plasma to a standard aliquot tube.  Immediately freeze the specimen on dry ice or at -70°C.

Transport Temperature:
Critical Frozen – send the frozen specimen via Priority Overnight in a well-insulated container on dry ice.

Thawed specimens or specimens stored at or above -20°C will not be accepted.

Reference Range
• 0 – 780 ng/mL

Complement Component Level 4A (COMP4A)

Separate specimens must be submitted when multiple tests are ordered.

Volume:
1 mL, plasma

Minimum volume:
0.5 mL

Collection Container:
Lavender BD Hemogard™ K2EDTA Tube

Collection Instructions:
Mix well. Centrifuge at room temperature within 30 minutes of collection, then transfer plasma to a standard aliquot tube and freeze immediately.  Plasma may be frozen at -20°C then transferred to dry ice for shipment within 6 hours or immediately frozen on dry ice/at -70°C or below.

Transport Temperature:
Critical Frozen – send the frozen specimen via Priority Overnight in a well-insulated container on dry ice.

Thawed specimens or specimens stored at room temperature prior to shipment are unacceptable.

Reference Range
• 0 – 2,830 ng/mL

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.

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.