Category: Special Communication

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

Special Communication

Changes To COMPC1, COMP3A, & COMP4A Testing

Changes effective as of November 5, 2018.

COMPC1

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

COMP3A

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

COMP4A

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.

Special Communications
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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
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QuantiFERON-TB Gold Plus (QTB-Plus) 4-Tube Assay

Special Communication

QuantiFERON-TB Gold Plus

Effective September 12, 2018.

Cleveland Clinic Laboratories will only accept the QuantiFERON-TB Gold Plus (QTB-Plus) 4-Tube Assay for Mycobacterium tuberculosis testing (Normal: INFTBG, INFINC; High Altitude: INFTBP, INTPGP)

New QuantiFERON-TB Gold Plus Collection Tube Kits have a total of four (4) blood collection tubes instead of three.

Regular and High Altitude tubes are available to order from the Supply Storefront.

Please note: Prior to collection, tubes must be stored at 4° to 25°C.

Order QuantiFERON-TB Gold Plus Tubes

Important Details

The 3-Tube QuantiFERON System will no longer be accepted.

Line draws will no longer be accepted.
•  Venipuncture is the only acceptable draw type.

New order codes will be listed in the Test Directory on September 12, 2018.
• Collection sites, processing, handling, and incubation specifications will remain the same.

All unused 3-Tube QuantiFERON Kits should be returned to our laboratories.
• Tubes can be given to couriers or transport can be arranged through Client Services.

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
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August 2018: Changes to ADRENL & RICKGM Testing

Special Communication

Changes to ADRENL & RICKGM Testing

Adrenal Antibody (ADRENL)

Effective September 10, 2018.

Specimen Requirements

Specimen Requirements

Volume:
2 mL, serum

Minimum Volume:
0.5 mL, serum

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

Do not use Gold Serum Separation Tubes (SST).

Transport:
Refrigerated – send specimen to laboratories with cold packs

Test Details

Interfaced Clients Only: The ADRENL test build may need to be modified.

Stability

Ambient:
48 hours

Refrigerated:
14 days

Frozen:
30 days

Methodology

Immunofluorescence

Reference Range

Normal Individuals
Negative

Days Performed/Reported

Performed
Wednesday, Friday

Turnaround Time
3–8 days

Special Information

Special Information

If the Adrenal Antibody screen is positive, then an Adrenal Antibody Titer will be performed at an additional cost.

Clinical Information

Clinical Information

Adrenal antibody is detected in patients with autoimmune adrenal disease (e.g., Addison’s disease).

Discontinued: Rickettsia Antibodies, IgG & IgM

Effective September 10, 2018, Rickettsia Antibodies IgG & IgM (RICKGM) will be discontinued.

We suggest ordering Rickettsia rickettsii IgG & IgM Abs (ROCKY) and Rickettsia typhi IgG & IgM Abs (TYPHUS).

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
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June 2018: Changes to Cyanide, Blood (CYANID) Testing

Special Communication

Changes to Cyanide, Blood (CYANID) Testing

Effective August 15, 2018.

Specimen Requirements

Specimen Requirements

Volume:
4 mL, whole blood

Minimum Volume:
3 mL, whole blood

Specimen Container (Primary):
Green Sodium Heparin Tube

Specimen Container (Primary):
Green Lithium Heparin Tube

Alternative Container:
Lavender BD Hemogard™ K2EDTA Tube

Serum or plasma specimens are unacceptable.

Transport:
Ambient (room) temperature

Patient Preparation:
Timing of specimen collection is dependent on the time of exposure; test upon presentation to hospital.

Test Details

Stability

Ambient
72 hours, if tightly-capped

Refrigerated
Unacceptable

Frozen
Unacceptable

Methodology

Quantitative Colorimetric

Reference Range

Non-smoker: < 20 μg/dL

Smoker: < 40 μg/dL

Days Performed/Reported

Performed
Sunday, Wednesday, and Friday

Turnaround Time
2–6 days

Special Information

Special Information

Timing of specimen collection is dependent on the time of exposure; test upon presentation to hospital.

This test is New York DOH approved.

Frozen or refrigerated specimens will be rejected.

Clotted or hemolyzed specimens will be rejected.

Serum or plasma specimens are unacceptable.

Clinical Information

Clinical Information

This test is used to monitor cyanide exposure. Cyanide poisoning can cause hypoxia, dizziness, weakness, and mental and motor impairment.

Elevated cyanide concentrations rarely indicate toxicity for patients on nitroprusside therapy. Thiocyanate should be monitored in patients on nitroprusside therapy for potential toxicity. Toxicity may occur with long-term nitroprusside use (longer than 7–14 days with normal renal function, and 3-6 days with renal impairment at greater than 2 μg/kg/min infusion rates).

Thiocyanate levels may be monitored on an every-other-day basis to assess potential thiocyanate toxicity and to indicate possible adjustments in dosage.

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

April 2018: Changes to Chemistry Tests

Special Communication

Changes to Chemistry Tests

Changes effective as of April 17, 2018

Tests

6-Monoacetylmorphine (6-MAM) Confirmation, Urine (U6AMCO)

Amphetamine Confirmation, Urine (UAMPC)

Benzodiazepines Conf, Urine (UBENZC)

Benzoylecgonine Confirmation/Quantitation (BECGO)

Buprenorphine Quant, Urine (UQNTBU)

Cannabinoid Confirmation, Urine (UTHCC)

Cocaine Confirmation, Urine (UCOCC)

Fentanyl and Metabolite, Urine (UFENT)

Methadone Quantitation, Urine (UQMET)

Opiate Confirmation, Urine (OPICON)

Oxycodone Confirmation, Urine (UOXYCC)

Quantitative Pain Panel, Urine (UQNTPP)

Tramadol and Metabolite, Quantitation (TRAQNT)

Build / Reference Range

Specimen Validity pH, Urine:
4.5 – 8.0

Specimen Validity Specific Gravity, Urine:
1.002 – 1.030

Specimen Validity Creatinine, Urine:

18–99 Years (Male):
46.8 – 314.5 mg/dL

18–99 Years (Female):
42.2 – 237.9 mg/dL

Specimen Validity Nitrites, Urine:
≤ 50 mg/L

Specimen Validity Oxidants, Urine:
< 200 mg/L

Specimen Validity Chromate, Urine:
< 50 mg/L

Oxycodone

In addition to build and special/clinical information changes, the following tests will also have an adjustment to the reference range for Oxycodone:

Tests

Opiate Confirmation, Urine (OPICON)

Oxycodone Confirmation, Urine (UOXYCC)

Quantitative Pain Panel, Urine (UQNTPP)

Reference Range

Oxycodone, Urine:
< 10 ng/mL

Special Information

Specimen Validity Testing (SVT) analytes have a stability of up to 5 days at 2 – 8 °C, as stated in the Instructions for Use (IFU).

Based on the laboratory’s studies, this stability is based on samples that have reached an equilibrium.

  • Introduction of oxidants to a urine sample will not be stable until an equilibrium is achieved.
  • Time to reach equilibrium will vary dependent on the type and amount of oxidant used as an adulterant.

Clinical Information

For Specimen Validity Interpretations, the following rules are applied:

Diluted

Creatinine: ≥ 2 mg/dL but < 20 mg/dL

Specific Gravity: > 1.0010 but < 1.0030

Substituted

Creatinine: < 2 mg/dL

Specific Gravity: < 1.0010 or ≥ 1.0200

Adulterated

pH: < 3.0 or ≥ 11.0

or Nitrites: ≥ 500 mg/L

or Oxidants: ≥ 200 mg/L

or Chromate: ≥ 50 mg/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.

Special Communications
Immediate Test Changes
News & Updates

April 2018: Upcoming Test Changes

Special Communication

April 2018 – Upcoming Changes to Testing

Beginning in April 2018, there will be several testing changes, discontinuations, and additions:

Folate RBC

Folate, Red Blood Cell (RBCFLP)

This new test will replace FOLRBC.  It includes Folate RBC and Hematocrit.

Test Name

Folate RBC (RBCFLP)

Clinical Information

Aids in detecting folate deficiency.

CPT Codes

82747 x 1

85014 x 1

Methodology

Automated Cell Counter and Quantitative Chemiluminescent Immunoassay

Turnaround Time

Testing will be performed Sunday through Saturday.

Reporting time will be 2–3 days.

Specimen Requirements

This test requires multiple specimen tubes.

Separate specimens must be submitted when multiple tests are ordered.

Tube 1:

  • Collect 1 ml whole blood in a Lavender BD Hemogard™ K2EDTA Tube.
  • Protect tubes from light during collection, storage, and shipment.
  • Mix specimen well, transfer into an amber transport tube, freeze, and transport frozen (critical).

Tube 2:

  • Collect 2.5 mL whole blood in a Lavender BD Hemogard™ K2EDTA Tube.
  • Fill tube to at least half of fill volume, and send refrigerated.
  • Note: Minimum volume is 1 mL split between 2 aliquots of 0.5 mL each.

Stability

Folate RBC:

Ambient: 2 hours

Refrigerated: 4 hours

Frozen: 2 months

Hematocrit:

Ambient: 24 hours

Refrigerated: 48 hours

Frozen: Unacceptable

Reference Range

Folate RBC:

≥ 366 ng/mL

Hematocrit:

0 – 14 Days: 39.6 – 57.2%

15 – 30 Days: 30.5 – 45.0%

31 – 60 Days: 26.8 – 37.5%

61 – 179 Days: 28.6 – 37.2%

6 – 23 Months: 30.8 – 37.9%

2 – 5 Years: 31.0 – 37.8%

6 – 11 Years: 32.2 – 39.8%

12 – 14 Years: 33.4 – 46.0%

15 – 99 Years (Male): 39.0 – 51.0%

15 – 99 Years (Female): 36.0 – 46.0%

Special Information

  • Hematocrit must be performed and submitted with the order.
  • If the patient has not received a transfusion or experienced excessive bleeding between the RBC folate draw and the hematocrit draw, any hematocrit drawn within 24 hours of the RBC folate draw is acceptable.
  • Folate RBC tube only: it is critical to submit the specimen as frozen; the specimen must be protected from light during collection, storage, and shipment.
  • Separate specimens must be submitted when multiple tests are ordered.
  • Specimens that are clotted or non-frozen will be rejected.
  • This test is New York DOH approved.

Torch Antibodies Panel

Torch Antibodies Panel, IgG & IgM (TORGMP)

Test Name

Torch Antibodies Panel, IgG & IgM (TORGMP)

Clinical Information

Toxoplasmosis IgM and IgG, Ab: Equivocal results should have a new sample collected and tested 3 weeks later.

Rubella IgG Ab: If exposure to Rubella is suspected and a negative result is obtained, a second specimen should be collected and tested 1-2 weeks later.  Equivocal results should have a second sample collected and tested.

Rubella IgM Ab: Parallel testing is preferred and convalescent specimens MUST be received within 30 days from receipt of acute specimens.

Herpes Simplex Type 1 and 2 IgG Antibodies: Equivocal results should be followed up by obtaining a new sample for re-testing.

Herpes Simplex IgM, Abs: A negative result does not rule out a primary or reactivated infection with HSV1 or HSV2 because the sample may have been obtained too early in the course of infection.  If a primary infection is suspected, obtain a new sample 1-2 weeks later.  Patients with equivocal results should have a new sample collected and tested 1-3 weeks later.

CPT Codes

86644 x 1

86645 x 1

86694 x 1

86695 x 1

86696 x 1

86762 x 2

86777 x 1

86778 x 1

Methodology

Chemiluminescence Immunoassay (CLIA)

Chemiluminescent Microparticle Immunoassay (CMIA)

Enzyme Immunoassay (EIA)

Multiplex

Semi-Quantitative Chemiluminescent Immunoassay

Turnaround Time

Refer to individual components.

Stability

After separation from cells:

Ambient: 8 hours

Refrigerated: 48 hours (note: For Rubella IgM: 2 weeks)

Frozen: 14 days

Reference Range

Refer to report.

Special Information

Grossly hemolyzed, icteric, lipemic, and heat-inactivated samples are unacceptable.

Samples containing particulate matter or exhibiting obvious microbial contamination will be rejected.

Test Updates

Glomerular Basement Membrane IgG (GBMBG)

GBMBG updates will occur on April 26, 2018.

Changes to special/clinical information, specimen requirements, stability, methodology, reference range, and days performed/reported were originally scheduled for May 8 in the March 2018 Technical Update.

Norovirus Group 1 and 2 Detection by PCR (NORPCR)

NORPCR updates will occur on April 26, 2018.

Changes to special/clinical information, specimen requirements, stability, methodology, reference range, and days performed/reported were originally scheduled for May 8 in the March 2018 Technical Update.

Discontinued Tests

EBV by PCR Qualitative (EBPCR)

EBPCR will be discontinued on April 12, 2018. 

Discontinuation was originally scheduled for May 8 in the March 2018 Technical Update.

We suggest ordering EBV by PCR Quantitative (EBVQNT).

RBC Folate (FOLRBC)

FOLRBC will be discontinued on April 26, 2018.

We suggest ordering Folate RBC (RBCFLP).

Torch Antibodies, IgG & IgM (TORCH)

TORCH will be discontinued on April 26, 2018.

We suggest ordering Torch Antibodies Panel, IgG & IgM (TORGMP).

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

Special Communications
Immediate Test Changes
News & Updates

December 2017: Changes to Chemistry Testing Go-Live Dates

Special Communication

Changes to Chemistry Testing Go-Live Dates

Due to unforeseen circumstances, the go-live dates for the following tests will be delayed until the indicated date.

Please continue to follow the current protocol for testing until the revised go-live date.

January 9 Go-Live:

• Lithium (LI)

February 28 Go-Live:

• Acetaminophen (ACETM)
• Amikacin, Post Dose (AMIKPO)
• Amikacin, Pre Dose (AMIKPR)
• Amikacin, Random (AMIKRA)
• Ammonia (NH3)
• Carbamazepine (CARBAM)
• Ceruloplasmin (CERULO)
• Digoxin (DIG)
• Ethanol (ALCO)
• Gentamicin, Post Dose (GENTPO)
• Gentamicin, Pre Dose (GENTPR)
• Gentamicin, Random (GENTRA)

• Mycophenolic Acid (MYCOPH)
• Phenobarbital (PHEN)
• Phenytoin (PHT)
• Salicylate (SALI)
• Theophylline (THEO)
• Tobramycin, Post Dose (TOBRPO)
• Tobramycin, Pre Dose (TOBRPR)
• Tobramycin, Random (TOBRRA)
• Toxicology Screen, Urine (UTOX2)
• Toxicology Screen, Urine with Confirmation (UTOXWC)
• Valproic Acid (VPA)
• Vancomycin (VANCRA)

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

Special Communications
Immediate Test Changes
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