Special Communication
Changes to Vitamin B12 (B12) Testing
Effective December 7, 2017.
Stability
Ambient:
24 hours
Refrigerated:
24 hours
Frozen:
2 months – freeze once and protect from light
Reference Range
232 – 1245 pg/mL
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.
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
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)
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.
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.
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.
August 2018: Changes to ADRENL & RICKGM Testing
Special Communication
Changes to ADRENL & RICKGM Testing
Adrenal Antibody (ADRENL)
Effective September 10, 2018.
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
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
If the Adrenal Antibody screen is positive, then an Adrenal Antibody Titer will be performed at an additional cost.
Clinical Information
Adrenal antibody is detected in patients with autoimmune adrenal disease (e.g., Addison’s disease).
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 2018: Changes to Cyanide, Blood (CYANID) Testing
Special Communication
Changes to Cyanide, Blood (CYANID) Testing
Effective August 15, 2018.
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.
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
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
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.
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:
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.
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, 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, 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
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).
February 2018: Polio Testing Update
Special Communication
Polio Testing Update
Effective on March 12, 2018, Poliovirus (Types 1, 3) Antibodies, IFA (POLIO) will be discontinued.
We suggest ordering Polio Neutralization (PNEUT) for future testing.
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)