***EFFECTIVE MARCH 21, 2012*** Hepatitis C Virus Antibody (RIBA), Supplemental ( ) and Associated Tests UNAVAILABLE

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1 ***EFFECTIVE MARCH 21, 2012*** Hepatitis C Virus Antibody (RIBA), Supplemental ( ) and Associated Tests UNAVAILABLE Due to a nationwide reagent backorder from a single source vendor, the Hepatitis C Virus Antibody (RIBA), Supplemental and associated tests are unavailable as of 3/21/2012. The vendor has provided no plan for resolution of the backorder in the near future. The following tests will be unavailable as of March 21, 2012 due to the reagent backorder: Hepatitis C Virus Antibody (RIBA), Supplemental (ARUP test code ) Hepatitis C Virus Antibody with Reflex to Supplemental RIBA (ARUP test code ) Hepatitis C Virus RNA Quantitative bdna with Reflex to Hepatitis C Virus Antibody (RIBA), Supplemental (ARUP test code ) Hepatitis C Virus Antibody RNA Qualitative PCR with Reflex to Hepatitis C Virus Antibody (RIBA), Supplemental (ARUP test code ) Hepatitis C Virus Antibody RNA Quantitative by Real-Time PCR with Reflex to Hepatitis C Virus Antibody (RIBA), Supplemental (ARUP test code ) RECOMMENDATIONS for follow-up testing The HCV RIBA reagent back order presents an educational opportunity to adopt efficient HCV testing algorithms. For more information regarding diagnosis and laboratory testing refer to the Diagnosis tab of the entry in ARUP Consult for Hepatitis C Virus - HCV at For follow up to a low positive Hepatitis C Virus Antibody by CIA (Chemiluminescent Immunoassay) result, and in lieu of the unavailable HCV RIBA, ARUP offers the two options below. Please note that due to stringent specimen integrity requirements for testing by PCR, specimens may not be eligible for PCR testing subsequent to antibody testing Hepatitis C Virus RNA Quantitative, Real-Time PCR HEPCQNT Specimen Required: Collect: Lavender (EDTA), pink (K 2EDTA), or serum separator tube. Specimen Preparation: Separate serum or plasma from cells within 6 hours. Transfer 3.5 ml serum or plasma to an ARUP Standard Transport Tube. (Min: 1.8 ml) Unacceptable Conditions: Heparinized specimens. Stability (collection to initiation of testing): On Cells: Ambient: 6 hours; After separation from cells: Refrigerated: 72 hours; Frozen: 6 weeks This assay has a lower limit of detection of 18 IU/mL, and a lower limit of quantitation of 43 IU/mL Hepatitis C Virus RNA Qualitative PCR HEP C PCR Specimen Required: Collect: Lavender (EDTA), pink (K 2EDTA), or serum separator tube. Specimen Preparation: Separate serum or plasma from cells within 6 hours. Transfer 2 ml serum or plasma to an ARUP Standard Transport Tube. (Min: 0.25 ml) Unacceptable Conditions: Heparinized specimens. Stability (collection to initiation of testing): On cells: Ambient: 6 hours. After separation from cells: Refrigerated: 72 hours; Frozen: 4 months This assay has a lower limit of detection of 100 IU/mL. Page 1

2 This Hot Line is published by ARUP Laboratories to notify clients of updates to our test menu. New tests, inactivated tests, and test changes will be included in the Hot Line, which is published twice monthly, as needed. Hot Lines and the up-to-date Laboratory Test Directory may also be viewed on our Web site at aruplab.com. For additional information, contact ARUP Client Services at (800) Changes are indicated by the red type. Note that only amended fields of an assay appear in this publication. All other fields remain the same. A red check mark ( ) indicates changes that also apply to other tests. Unless otherwise indicated, the tests updated in this Hot Line are referred outside of ARUP Laboratories and reflect the changes made by the laboratory where specimens are sent for testing. MEDICARE COVERAGE OF LABORATORY TESTING Please remember when ordering laboratory tests that are billed to Medicare/Medicaid or other federally funded programs, the following requirements apply: 1. Only tests that are medically necessary for the diagnosis or treatment of the patient should be ordered. Medicare does not pay for screening tests except for certain specifically approved procedures and may not pay for non-fda approved tests or those tests considered experimental. 2. If there is reason to believe that Medicare will not pay for a test, the patient should be informed. The patient should then sign an Advance Beneficiary Notice (ABN) to indicate that he or she is responsible for the cost of the test if Medicare denies payment. 3. The ordering physician must provide an ICD-9 diagnosis code or narrative description, if required by the fiscal intermediary or carrier. 4. Organ- or disease-related panels should be billed only when all components of the panel are medically necessary. 5. Both ARUP- and client-customized panels should be billed to Medicare only when every component of the customized panel is medically necessary. 6. Medicare National Limitation Amounts for CPT codes are available through the Centers for Medicare & Medicaid Services (CMS) or its intermediaries. Medicaid reimbursement will be equal to or less than the amount of Medicare reimbursement. The CPT Code(s) for test(s) profiled in this bulletin are for informational purposes only. The codes reflect our interpretation of CPT coding requirements, based upon AMA guidelines published annually. CPT codes are provided only as guidance to assist you in billing. ARUP strongly recommends that clients reconfirm CPT code information with their local intermediary or carrier. CPT coding is the sole responsibility of the billing party. The regulations described above are only guidelines. Additional procedures may be required by your fiscal intermediary or carrier Blastomyces dermatitidis Antigen EIA BLAST DERM Specimen Required: Collect: Random urine OR plain red, serum separator tube, or green (sodium or lithium heparin). Also acceptable: CSF or BAL. Specimen Preparation: Transfer 2 ml urine, serum, or plasma to an ARUP Standard Transport Tube. (Min: 1 ml) Storage/Transport Temperature: Refrigerated. Also acceptable: Room temperature or frozen. Unacceptable Conditions: EDTA plasma. Stability (collection to initiation of testing): Ambient: 2 weeks; Refrigerated: 2 weeks; Frozen: Indefinitely Complement Activity, Alternative Pathway (AH50) AH50 Assay improvement affecting reference interval. Reference Interval: Effective April 2, percent normal or greater Corticotropin Releasing Hormone CORT REL Specimen Required: Collect: Collect: Green (sodium heparin). Specimen Preparation: Transport 3 ml plasma. (Min: 1.1 ml) Storage/Transport Temperature: Refrigerated. Also acceptable: Frozen. Stability (collection to initiation of testing): Ambient: 72 hours; Refrigerated: 1 week; Frozen: 1 month Page 2

3 FibroSURE HCV FIBRO Specimen Required: Patient Preparation: Patient must be 14 years of age or older. Collect: Plain red or serum separator tube. Specimen Preparation: Separate from cells within one hour of collection. Transfer 3 ml serum to an ARUP standard Transport Tube. (Min: 3 ml) Remarks: Patient age and gender must be included on the request form. Unacceptable Conditions: Grossly hemolyzed or lipemic specimens. Stability (collection to initiation of testing): Ambient: Unacceptable; Refrigerated: 72 hours; Frozen: 1 month HemoQuant, Fecal HEMO FECES Specimen Required: Patient Preparation: Patient should not ingest red meat or aspirin for at least 72 hours prior to collection. Collect: Stool from a single defecation in a sterile, plastic, screw-top container with no preservatives. Specimen Preparation: Transport 1 g stool. (Min: 1 g) Storage/Transport Temperature: Refrigerated. Also acceptable: Frozen or room temperature. Stability (collection to initiation of testing): Ambient: 1 week; Refrigerated: 1 week; Frozen: 1 month Interpretive Data: Test Information: This test detects the presence of blood in feces and is appropriate for use in the evaluation of iron deficiency. Other uses include detection of bleeding as a result of anticoagulant therapy or from other medically prescribed treatment regimens. HOT LINE NOTE: Remove information found in the Unacceptable Conditions field. Delete Hepatitis Delta Antigen HEP D AG HOT LINE NOTE: Delete this test and refer to Hepatitis Delta Antigen by ELISA ( ). New Test Hepatitis Delta Antigen by ELISA HEPD AG Qualitative Enzyme-Linked Immunosorbent Assay 3-10 days Specimen Required: Collect: Plain red. Specimen Preparation: Separate from cells within 1 hour of draw. Transfer 1 ml serum to an ARUP Standard Transport Tube and freeze immediately. (Min: 0.5 ml) Storage/Transport Temperature: CRITICAL FROZEN. Separate specimens must be submitted when multiple tests are ordered. Unacceptable Conditions: Grossly hemolyzed or lipemic specimens. Thawed specimens. Stability (collection to initiation of testing): Ambient: Unacceptable; Refrigerated: Unacceptable; Frozen: 3 months Reference Interval: By report CPT Code(s): New York DOH approval pending. Call for status update. HOT LINE NOTE: Refer to the Test Mix Addendum for interface build information Niacin (Vitamin B 3 ) NIACIN B days Specimen Required: Collect: Lavender (EDTA). Specimen Preparation: Protect from light. Transfer 4 ml plasma to an ARUP Amber Transport Tube and freeze immediately. (Min: 1 ml) Storage/Transport Temperature: CRITICAL FROZEN. Separate specimens must be submitted when multiple tests are ordered. Unacceptable Conditions: Thawed specimens or specimens not protected from light. Grossly hemolyzed or lipemic specimens. Stability (collection to initiation of testing): Ambient: Unacceptable; Refrigerated: Unacceptable; Frozen: 2 months Page 3

4 SCN1A-Related Seizure Disorders (SCN1A), Sequencing and Deletion/Duplication SCN1A COM Polymerase Chain Reaction/Sequencing/Multiplex Ligation-dependent Probe Amplification Assay days CPT Code(s): Isolation, Digestion, x26 Nucleic acid probes, x29 Amplification, Multiplex amplification, x24 Amplification, x21 Mutation scanning, x16 Sequencing, Capillary electrophoresis, Interpretation and report New Test Selection of Retrieved Archived Tissue APBLOCKSEL New test to enhance customer service and provide communication for ancillary testing on stored Pathology specimens. Block evaluation and selection for ancillary testing Mon-Sat Within 48 hours Specimen Required: Collect: Paraffin block from a case performed by ARUP / Department of Pathology at University of Utah Hospital. Storage/Transport Temperature: Room temperature or refrigerated. Remarks: This test is for the selection of a block from a case performed, and blocks retained at ARUP Laboratories and/or Department of Pathology for University of Utah Hospital. Unacceptable Conditions: Any case performed elsewhere or if there is not enough usable tissue in the block for requested testing. Stability (collection to initiation of testing): Ambient: Indefinitely; Refrigerated: Indefinitely; Frozen: Indefinitely HOTLINE NOTE: Results will include specific information about the specimen selected for ancillary testing. CPT Code(s): Stachybotrys chartarum/atra Panel II STACHPANII 5-10 days Tin Total, Serum or Plasma TIN SP Specimen Required: Collect: Royal blue (no additive or EDTA). Specimen Preparation: Transfer 1 ml serum or plasma to an ARUP Standard Transport Tube. (Min: 0.4 ml) Storage/Transport Temperature: Refrigerated. Unacceptable Conditions: Separator tubes. Stability (collection to initiation of testing): Ambient: 2 weeks; Refrigerated: 2 weeks; Frozen: 2 weeks HOT LINE NOTE: There is a component change associated with this test that affects interface clients only. Refer to Test Mix Addendum for further information Tropheryma whipplei DNA, Qualitative RT PCR T WHIPPLEI Specimen Required: Collect: Lavender (EDTA), pink (K 2EDTA), or yellow (ACD solution A or B). Also acceptable: CSF or tissue. Specimen Preparation: Transport 0.7 ml whole blood or CSF. (Min: 0.3 ml) Tissue: Transport 3 mm tissue in an ARUP Standard Transport Tube with sterile saline to prevent drying. (Min: 3 mm) Storage/Transport Temperature: Refrigerated. Tissue: Frozen. Stability (collection to initiation of testing): Ambient: 48 hours; Refrigerated: 1 week; Frozen: Whole blood: Unacceptable, CSF or Tissue: 1 month HOT LINE NOTE: There is a clinically significant charting name change associated with this test. Interface clients, refer to Test Mix Addendum for further information. Page 4

5 Vitamin D, 25-Hydroxy VIT D 25 The vendor (DiaSorin) made modifications to their Vit D kit which impacts the acceptable specimen type. Only serum and Lithium Heparin plasma are acceptable. DiaSorin has discontinued the old kit. Specimen Required: Collect: Serum separator tube. Also acceptable Green (sodium or lithium heparin). Specimen Preparation: Transfer 1 ml serum or heparinized plasma to an ARUP Standard Transport Tube. (Min: 0.3 ml) Storage/Transport Temperature: Refrigerated. Unacceptable Conditions: Tissue or urine. Grossly hemolyzed or lipemic specimens. Stability (collection to initiation of testing): After separation from cells: Ambient: 72 hours; Refrigerated: 1 week; Frozen: 6 months Zolpidem, Urine - Screen with Reflex to Confirmation/Quantitation ZOLPIDEM Quantitative High Performance Liquid Chromatography/Tandem Mass Spectrometry 3-10 days Specimen Required: Collect: Random urine. Specimen Preparation: Transfer 1 ml urine to an ARUP Standard Transport Tube. (Min: 0.5 ml) Storage/Transport Temperature: Refrigerated. Also acceptable: Room temperature or frozen. Stability (collection to initiation of testing): Ambient: 1 week; Refrigerated: 1 month; Frozen: 1 month CPT Code(s): 80100; if positive, add Page 5