November 2022 WML Test Directory Update

Suggested replacement is test code BSDQL – Borrelia species DNA, Qual Real-Time PCR.

Update to turnaround time and performed days.

Performed Days: Monday – Friday 

Turnaround Time: 1 – 3 days 

Update to performed days and turnaround time.

Performed Days: Monday – Friday

Turnaround Time: 1 – 3 days

Update to specimen preparation, alternate specimen, rejection criteria, and performing laboratory.

Specimen Preparation: Send 1.0 mL serum collected in a serum separator tube. PROTECT FROM LIGHT.

Alternate Specimen: No alternate specimen accepted.

Rejection Criteria: Samples that are not shipped the same day of collection; samples without protection from light exposure; red top tube (no gel).

Performing Laboratory: Quest SJC performed at Cleveland HeartLab, Inc. 

Update to performed days and turnaround time.

Performed Days: Monday – Friday

Turnaround Time: 1 – 3 days

Update to specimen preparation, rejection criteria, reference range, and performing laboratory.

Specimen Preparation: Place 10.0 g or 10.0 mL stool in a Total-Fix® transport vial. Stool must be collected in a clean dry container and must not be contaminated with urine or water. Add stool to bring the liquid to the “fill to here” line and mix contents until homogeneous.

Rejection Criteria: Stool in Cary-Blair transport medium, frozen stool, specimens containing barium or received in other than Zn-PVA or Total-Fix®, unpreserved stool

Reference Range:  Fecal Leukocyte      Not Detected

Performing Laboratory:  Quest SJC

Update to specimen preparation, alternate specimen, rejection criteria, and stability.

Collect:  HCV Antibody Screen: Serum Separator Tube (SST)
HCV PCR: Lavender EDTA
*Both specimens required. 

Specimen Preparation:

HCV Antibody Screen (Label: HCAB) –
Centrifuge, separate serum from cells and send 1.0 mL serum in a screw capped plastic vial.

HCV PCR Plasma (Label: HCVFR):
Centrifuge, separate plasma from cells within 6 hours of collection. Send 3.0 mL plasma in screw capped plastic vial.

*PCR and antibody testing cannot be done on shared specimens. Separate tubes must be clearly labeled for antibody and PCR specimens.

Alternate Specimen:

HCV Antibody: red top, lavender EDTA (follow Plasma collection guide for PCR )
HCV PCR: Serum: red top

*PCR and antibody testing cannot be done on shared specimens. Separate tubes must be clearly labeled for antibody and PCR specimens.

Rejection Criteria:

HCV Antibody: red top, lavender EDTA (follow Plasma collection guide for PCR )
HCV PCR: Serum: red top

*PCR and antibody testing cannot be done on shared specimens. Separate tubes must be clearly
labeled for antibody and PCR specimens.

Stability:

HCV Antibody:
Room temperature: Undetermined
Refrigerated: 7 days
Frozen: Undetermined

HCV PCR:
Room temperature: Unacceptable
Refrigerated: 3 days
Frozen: 60 days

Update to specimen preparation, stability, rejection criteria, and alternate specimen.

Collect: HCV Antibody Screen: Serum Separator Tube (SST)
HCV PCR: Lavender EDTA
*Both specimens required. 

Specimen Preparation:

HCV Antibody Screen (Label: HCAB) –
Centrifuge, separate serum from cells and send 1.0 mL serum in a screw capped plastic vial.

HCV PCR Plasma (Label: HCVFR):
Centrifuge, separate plasma from cells within 6 hours of collection. Send 3.0 mL plasma in screw
capped plastic vial.

*PCR and antibody testing cannot be done on shared specimens. Separate tubes must be clearly labeled for antibody and PCR specimens.

Alternate Specimen:

HCV Antibody: red top, lavender EDTA (follow Plasma collection guide for PCR )
HCV PCR: Serum: red top

*PCR and antibody testing cannot be done on shared specimens. Separate tubes must be clearly labeled for antibody and PCR specimens.

Rejection Criteria: HCV Antibody: gross hemolysis, gross lipemia, heparin plasma

HCV PCR: gross hemolysis, gross lipemia, heparin plasma, gel-based plasma separation tubes, specimens subjected to repeat freeze thaw cycles, shared specimens

Stability:

HCV Antibody:
Room temperature: Undetermined
Refrigerated: 7 days
Frozen: Undetermined

HCV PCR:
Room temperature: Unacceptable
Refrigerated: 3 days
Frozen: 60 days

Update to rejection criteria.

Rejection Criteria: Clotted specimen, lavender EDTA tube 

Update to test name, patient preparation, rejection criteria, methodology, performed days, and performing location.

Test Name: Osteocalcin, N-MID

Patient Preparation: Dietary supplements containing biotin may interfere in assays and may skew results to be either falsely high or falsely low. For patients receiving the recommended daily doses of biotin, draw samples at least 8 hours following the last biotin supplementation. For patients on mega doses of biotin supplements, draw samples at least 72 hours following the last biotin supplementation.

Rejection Criteria: Hemolysis, heat inactivated samples, serum separator tube (SST), specimens stabilized with azide, patient administered with biotin within 8 hours

Methodology: Electrochemiluminescence immunoassay (ECLIA) 

Performed Days: Monday – Saturday

Performing Laboratory: Quest SJC

Update to transport temperature.

Transport Temperature: Refrigerated

Update to reference range.

Reference Range: <11 ug/L 

Update to stability.

Stability:

Room temperature: Unacceptable
Refrigerated: Unacceptable
Frozen: 30 days

Update to stability.

Stability:

Room temperature: Unacceptable
Refrigerated: Unacceptable
Frozen: 30 days

Update to reference range.

Reference Range: Venlafaxine + O-desmethylvenlafaxine: 100 – 400 ng/mL 

Update to stability.

Stability:

Room temperature: 30 days
Refrigerated: 30 days
Frozen: 4 months

Update to stability and methodology.

Stability: Room temperature: 30 days
                Refrigerated: 30 days
                Frozen: 3 months 

Methodology: LC-MS/MS

Update to specimen preparation and rejection criteria.

Specimen Preparation: Send 1.0 mL vitreous fluid refrigerated in a preservative free screw capped plastic vial.

Rejection Criteria: Grey top tube (sodium fluoride or potassium oxalate) 

Update to specimen preparation, stability, rejection criteria, and methodology.

Specimen Preparation: Centrifuge, separate serum from cells and send 1.0 mL serum refrigerated in a screw capped plastic vial.

Rejection Criteria: Serum separator tube (SST) or Plasma separator tube (PST), samples received at room temperature 

Stability: Room temperature: Unacceptable
                Refrigerated: 30 days
                Frozen: 3 months 

Methodology: LC-MS/MS 

Update to stability and performed days.

Stability: Room temperature: Unacceptable
                Refrigerated: 7 days
                Frozen: 3 months (if frozen within 24 hours)

Performed Days: Sunday – Saturday 

Update to specimen preparation, alternate specimen, rejection criteria, stability, and performed days.

Specimen Preparation: Whole Blood or Maternal cell contamination specimen:
Send 3.0 mL whole blood refrigerated in a screw capped plastic vial.

Alternate Specimen: Whole blood or Maternal cell contamination specimens: Yellow ACD solution A or B

Rejection Criteria: Plasma or serum. Specimens collected in sodium heparin or lithium heparin tubes. Frozen specimens in glass collection tubes. 

Stability: Whole blood or Maternal cell contamination specimen:
                 Room temperature: 72 hours
                 Refrigerated: 7 days
                 Frozen: 30 days 

Performed Days: Varies

Update to rejection criteria.

Rejection Criteria: Hemolyzed or lipemic specimens, plasma

Update to rejection criteria.

Rejection Criteria: Smears fixed with cytology fixative, excessively bloody samples, DNA probe transport device, viral transport medium, stool, broken slides, corneal rim, bone, catheter tips, smears to thick to read, slides previously stained by cytology and cover slipped. 

Update to CPT codes.

CPT Code(s): 81120, 81121

Update to CPT code.

CPT Code(s): 81287

Update to test name, patient preparation, stability, methodology, and reference range.

Test Name: Sertraline, Serum or Plasma

Patient Preparation: Pre-dose (trough) draw at steady state concentration.

Stability:

Room temperature: 24 hours
Refrigerated: 14 days
Frozen: 4 months

Methodology: Liquid Chromatography – Tandem Mass Spectrometry 

Reference Range:

Therapeutic Range: 30 – 200 ng/mL
Toxic: > 300 ng/mL

Update to test name, specimen requirements, stability, rejection criteria, methodology, reference range, and performed days.

Test Name: Transforming Growth Factor beta1, Serum

Specimen Preparation: Centrifuge, remove serum from cells ASAP or within two hours of collection and send 1.0 mL serum in screw capped plastic vial. CRITICAL FROZEN

Separate specimens must be submitted when multiple tests ordered.

New York DOH Approval Status: Pending

Rejection Criteria: Contaminated, severely hemolyzed, heat-inactivated or grossly lipemic specimens 

Stability:

Room temperature: 30 minutes
Refrigerated: Unacceptable
Frozen: 60 days

Methodology: Quantitative Enzyme-Linked Immunosorbent Assay 

Reference Range: 16542 – 50426 pg/mL 

Performed Days:  Monday

Update to test name, specimen requirements, rejection criteria, stability, methodology, reference range, NY DOH approval status, and performed days.

Test Name: Transforming Growth Factor beta1, Serum

Collect: Lavender 

Specimen Preparation: Centrifuge anticoagulated whole blood within 2 hours of collection at 1500 g for 10 minutes. Collect plasma and transfer to fresh tube. Immediately centrifuge plasma at 3000 g for 10 minutes. Collect plasma from upper 2/3 of tube without disturbing lower 1/3 of tube and transfer to fresh tube for storage or transport. Separate plasma from cells ASAP or within 2 hours of collection. Send 1.0 mL plasma in a screw capped plastic vial. CRITICAL FROZEN 

Separate specimens must be submitted when multiple tests are ordered.

New York DOH Approval Status: Pending

Rejection Criteria: Contaminated, severely hemolyzed, heat-inactivated or grossly lipemic specimens 

Stability:

After separation from cells:
Room temperature: 30 minutes
Refrigerated: Unacceptable
Frozen: 60 days

Methodology: Quantitative Enzyme-Linked Immunosorbent Assay 

Reference Range: 1654 – 19951 pg/mL

Performed Days: Monday

Update to alternate specimen, stability, and rejection criteria.

Alternate Specimen:

Whole Blood: ACD yellow top tube, royal blue top, sodium or lithium heparin green tube.

Bone marrow:
Collect and send 10.0 mL (10.0 mL minimum) bone marrow in Lavender EDTA tube.

Rejection Criteria: Do not reject.

Stability: Whole blood or bone marrow:
               Room temperature: 8 days
               Refrigerated: 8 days
               Frozen: Unacceptable

Update to specimen preparation and performed days.

Specimen Preparation: Centrifuge and separate serum from cells and send 1.0 mL serum in a preservative free screw capped plastic vial.

Performed Days: Sunday – Saturday