Streptococcus pneumoniae IgG AB (13 Serotypes), MAID... 7

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1 Volume 12 December 2011 Table of Contents Summary of Test Changes... 3 Test Changes... 6 Human Anti-Mouse AB (HAMA), ELISA... 6 Hepatitis E Antibody (IgG, IgM)... 6 Hepatitis E Antibody (IgG)... 6 Hepatitis E Antibody (IgM)... 7 IgG AB (6 Serotypes), MAID... 7 IgG AB (7 Serotypes), MAID... 7 IgG AB (12 Serotypes), MAID... 7 IgG AB (13 Serotypes), MAID... 7 IgG AB (14 Serotypes), MAID... 7 IgG AB (23 Serotypes), MAID... 7 Herpes Simplex Virus 1/2 (IgG) Type-Specific Antibodies, CSF... 7 Herpes Virus-6 DNA, Qualitative Real-Time PCR... 7 Herpes Virus-6 DNA, Quantitative Real-Time PCR... 8 Susceptibility Panel, Gram-Negative Rods, MIC... 8 Cysticercus Antibody, ELISA (CSF)... 8 Lymphocytic choriomeningitis (LCM) Virus AB, IFA (CSF)... 8 Mumps Virus Direct Detection, DFA... 9 Custom MIC, 1 Drug... 9 Custom MIC/MFC, 1 Drug... 9 Custom MIC, 2 Drug... 9 Custom MIC/MFC, 2 Drug... 9 Custom MIC, 3 Drug... 9 Custom MIC/MFC, 3 Drug... 9 Custom MIC, 4 Drug... 9 Custom MIC, 5 Drug... 9 Custom MIC, 6 Drug... 9 Actin (Smooth Muscle) Antibody (IgG)... 9 Lymphogranuloma venereum (LGV) Diff AB Pnl, MIF (Serum) Strongyloides IgG Antibody, ELISA Cytomegalovirus (CMV) IgG Avidity (AviDx), ELISA Leishmania Antibody, IFA Borrelia hermsii Antibody Panel, IFA Campylobacter jejuni Antibody, ELISA Listeria Antibody, CF (Serum) Colorado Tick Fever Antibody, IFA Colorado Tick Fever IgG Antibody, IFA Colorado Tick Fever IgM Antibody, IFA Focus Diagnostics Page 1 of 11 December 2011

2 Myelin IgG Antibody, IFA Mycoplasma pneumoniae IgG Antibody, IFA (Serum) Mycoplasma pneumoniae IgM Antibody, IFA (Serum) Mycoplasma pneumoniae IgG and IgM Antibody, IFA (Serum) Mycoplasma pneumoniae IgG and IgM Antibody, IFA (CSF) Measles (Rubeola) IgG AB, IFA (CSF) Measles (Rubeola) IgM AB, IFA (CSF) Measles (Rubeola) IgG and IgM Antibody Panel, IFA (CSF) Toxoplasma gondii DNA, Qualitative Real-Time PCR Ehrlichia chaffeensis DNA Real-Time PCR Focus Diagnostics requires a current address to continue to provide updates to our reference laboratory menu. Please inform our Client Services Department if there is a change in staffing or address. Call (800) or [email protected]. All third party marks ' and ' are the property of their respective owners. The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge. Focus Diagnostics Page 2 of 11 December 2011

3 Summary of Test Changes Performing Site Test Code Test Code(s) Human Anti-Mouse AB (HAMA), ELISA Hepatitis E Antibody (IgG, IgM) Hepatitis E Antibody (IgG) Hepatitis E Antibody (IgM) IgG AB (6 Serotypes), MAID IgG AB (7 Serotypes), MAID IgG AB (12 Serotypes), MAID IgG AB (13 Serotypes), MAID IgG AB (14 Serotypes), MAID IgG AB (23 Serotypes), MAID Herpes Simplex Virus 1/2 (IgG) Type-Specific Antibodies, CSF Herpes Virus-6 DNA, Qualitative Real-Time PCR Herpes Virus-6 DNA, Quantitative Real-Time PCR Susceptibility Panel, Gram- Negative Rods, MIC Cysticercus Antibody, ELISA (CSF) Lymphocytic choriomeningitis (LCM) Virus AB, IFA (CSF) Mumps Virus Direct Detection, DFA Custom MIC, 1 Drug Specimen Requirements Transport Temperature Specimen Stability Units of Measure Reference Range Methodology CPT Codes Reject Criteria Other (see listing) Focus Diagnostics Page 3 of 11 December 2011

4 Performing Site Test Code Test Code(s) Custom MIC/MFC, 1 Drug Custom MIC, 2 Drug Custom MIC/MFC, 2 Drug Custom MIC, 3 Drug Custom MIC/MFC, 3 Drug Custom MIC, 4 Drug Custom MIC, 5 Drug Custom MIC, 6 Drug Actin (Smooth Muscle) Antibody (IgG) Lymphogranuloma venereum (LGV) Diff AB Pnl, MIF (Serum) Strongyloides IgG Antibody, ELISA Cytomegalovirus (CMV) IgG Avidity (AviDx), ELISA Leishmania Antibody, IFA Borrelia hermsii Antibody Panel, IFA Campylobacter jejuni Antibody, ELISA Listeria Antibody, CF (Serum) Colorado Tick Fever Antibody, IFA Colorado Tick Fever IgG Antibody, IFA Colorado Tick Fever IgM Antibody, IFA Myelin IgG Antibody, IFA Mycoplasma pneumoniae IgG Antibody, IFA (Serum) Mycoplasma pneumoniae IgM Antibody, IFA (Serum) Specimen Requirements Transport Temperature Specimen Stability Units of Measure Reference Range Methodology CPT Codes Reject Criteria Other (see listing) Focus Diagnostics Page 4 of 11 December 2011

5 Test Code(s) Mycoplasma pneumoniae IgG and IgM Antibody, IFA (Serum) Mycoplasma pneumoniae IgG and IgM Antibody, IFA (CSF) Measles (Rubeola) IgG AB, IFA (CSF) Measles (Rubeola) IgM AB, IFA (CSF) Measles (Rubeola) IgG and IgM Antibody Panel, IFA (CSF) Toxoplasma gondii DNA, Qualitative Real-Time PCR Ehrlichia chaffeensis DNA Real-Time PCR Performing Site Test Code Specimen Requirements Transport Temperature Specimen Stability Units of Measure Reference Range Methodology CPT Codes Reject Criteria Other (see listing) Focus Diagnostics Page 5 of 11 December 2011

6 Test Changes The following test changes will be effective on the dates indicated below. Please note that only the information that is changing appears in this update. Former test codes and test names have been italicized. Human Anti-Mouse AB (HAMA), ELISA ****This test change requires immediate action Effective Date: January 9, 2012 Test Code: Transport Temperature: Specimen Stability: Reference Range: Always Message: Refrigerated Room temperature: 7 days <75 ng/ml REFERENCE RANGE: <75 ng/ml INTERPRETIVE CRITERIA: <75 ng/ml Normal HAMA level >=75 ng/ml Increased HAMA level Assay Category: HAMA produced following therapeutic murine monoclonal antibody treatment may reduce the effectiveness of the monoclonal antibody therapy, or cause anaphylactic complications during subsequent rounds of treatment. HAMA may also be detected in a small percentage of the general population, and usually represent heterophilic antibodies or dietary exposure to murine proteins. FDA Approved Hepatitis E Antibody (IgG, IgM) Effective Date: January 23, 2012 Test Code: Always Message: REFERENCE RANGE: NOT DETECTED Hepatitis E virus (HEV) is a major cause of enteric non-a hepatitis worldwide. Both HEV IgM and IgG are typically detected within one month after infection; IgM persists for about two months, whereas IgG levels persist for months to years after recovery. Approximately 20% of the US population is positive for HEV IgG, indicating that HEV exposure is more common than previously thought. Assay Category: This test was developed and its performance characteristics have been determined by Focus Diagnostics. Performance characteristics refer to the analytical performance of the test. Laboratory Developed Test Hepatitis E Antibody (IgG) Effective Date: January 23, 2012 Test Code: Focus Diagnostics Page 6 of 11 December 2011

7 Always Message: REFERENCE RANGE: NOT DETECTED Hepatitis E virus (HEV) is a major cause of enteric non-a hepatitis worldwide. HEV IgG is typically detected within one month after infection, and persists for months to years after recovery. Approximately 20% of the US population is positive for HEV IgG, indicating that HEV exposure is more common than previously thought. Assay Category: This test was developed and its performance characteristics have been determined by Focus Diagnostics. Performance characteristics refer to the analytical performance of the test. Laboratory Developed Test Hepatitis E Antibody (IgM) Effective Date: January 23, 2012 Test Code: Always Message: REFERENCE RANGE: NOT DETECTED Hepatitis E Virus (HEV) is a major cause of enteric non-a hepatitis worldwide. HEV IgM is typically detected within 2-4 weeks after infection, and then persists for about two months. Assay Category: This test was developed and its performance characteristics have been determined by Focus Diagnostics. Performance characteristics refer to the analytical performance of the test. Laboratory Developed Test IgG AB (6 Serotypes), MAID IgG AB (7 Serotypes), MAID IgG AB (12 Serotypes), MAID IgG AB (13 Serotypes), MAID IgG AB (14 Serotypes), MAID IgG AB (23 Serotypes), MAID Effective Date: January 23, 2012 Specimen Stability: Room temperature: 7 days Frozen: 90 days Herpes Simplex Virus 1/2 (IgG) Type-Specific Antibodies, CSF Effective Date: February 13, 2012 Test Code: Additional Information: This test is not available for NY patient testing. For NY patient testing please order Herpes Simplex Virus, Type 1 & 2 DNA, Quantitative Real-Time PCR. Herpes Virus-6 DNA, Qualitative Real-Time PCR Effective Date: February 13, 2012 Test Code: Specimen Requirements: Amniotic fluid is no longer an acceptable specimen type. Focus Diagnostics Page 7 of 11 December 2011

8 Other Acceptable Specimens: The following will be added to the other acceptable specimen types at Focus: Bone marrow (EDTA, ACD), bronchoalveolar lavage, and tissue. Herpes Virus-6 DNA, Quantitative Real-Time PCR Effective Date: February 13, 2012 Test Code: Specimen Requirements: Amniotic fluid is no longer an acceptable specimen type. Other Acceptable Specimens: The following will be added to the other acceptable specimen types at Focus: Bone marrow (EDTA, ACD) and bronchoalveolar lavage Susceptibility Panel, Gram-Negative Rods, MIC Test Code: Former : Antimicrobial Susc, Gram-Negative Rods, MIC Panel CPU Interface Mapping: Result code: Type: Result Name: 150 Prompt Cysticercus Antibody, ELISA (CSF) Test Code: Specimen Stability: Room temperature: unacceptable Lymphocytic choriomeningitis (LCM) Virus AB, IFA (CSF) Test Code: Specimen Stability: Room temperature: unacceptable Organism Amikacin Ampicillin Ampicillin/Sulbactam Aztreonam Cefazolin Cefepime Cefoxitin Ceftazidime Ceftriaxone Cefuroxime Ciprofloxacin Gentamicin Imipenem Meropenem Piperacillin Piperacillin/Tazobactam Ticarcillin/Clavulanate Tobramycin Trimethoprim/Sulfamethoxazole Nitrofurantoin Focus Diagnostics Page 8 of 11 December 2011

9 Mumps Virus Direct Detection, DFA Test Code: Specimen Requirements: 1 throat swab in viral transport medium or equivalent, 1 slide, 0.5 ml CSF, or 0.5 ml urine Transport Temperature: Slide: Room temperature Swab, CSF or Urine: Frozen Reference Range: Not Detected Custom MIC, 1 Drug Custom MIC/MFC, 1 Drug Custom MIC, 2 Drug Custom MIC/MFC, 2 Drug Custom MIC, 3 Drug Custom MIC/MFC, 3 Drug Custom MIC, 4 Drug Custom MIC, 5 Drug Custom MIC, 6 Drug Specimen Requirements: 1 agar slant or plate Pure growth of isolated mature colonies of rapidly growing, non-fastidious yeast including Candida species, Cryptococcus species, and miscellaneous other rapid growing yeast. Rejection Criteria: Non-viable isolates, yeast mixed with filamentous fungi, mixed yeast or yeast mixed with bacteria, mold or filamentous fungi with no yeast, raw samples, mold or filamentous bacteria. Specimen Stability: Room temperature: acceptable, determined by viability Refrigerated: acceptable, determined by viability Frozen: unacceptable Actin (Smooth Muscle) Antibody (IgG) Test Code: Transport Temperature: Room temperature Specimen Stability: Room temperature: 14 days Always Message: REFERENCE RANGE: <20 units INTERPRETIVE CRITERIA: <20 units Negative > or = 20 units Positive Antibodies recognizing actin are the main component of smooth muscle antibodies associated with autoimmune liver disease. Actin antibodies are found in approximately 75% of patients with autoimmune hepatitis (AIH) type 1, approximately 65% of patients with autoimmune cholangitis, approximately 30% of patients with primary biliary cirrhosis, and approximately 2% of healthy controls. High values are closely correlated with AIH type 1. Focus Diagnostics Page 9 of 11 December 2011

10 Additional Information: Please note this test is included in the following profile code: 4966 Autoimmune Hepatitis AB Panel Lymphogranuloma venereum (LGV) Diff AB Pnl, MIF (Serum) Test Code: Specimen Requirements: Specimen Stability: 1 ml (0.2 ml min.) serum Room temperature: 7 days Strongyloides IgG Antibody, ELISA Cytomegalovirus (CMV) IgG Avidity (AviDx), ELISA Leishmania Antibody, IFA Borrelia hermsii Antibody Panel, IFA Campylobacter jejuni Antibody, ELISA Listeria Antibody, CF (Serum) Colorado Tick Fever Antibody, IFA Colorado Tick Fever IgG Antibody, IFA Colorado Tick Fever IgM Antibody, IFA Specimen Stability: Room temperature: 7 days Myelin IgG Antibody, IFA Mycoplasma pneumoniae IgG Antibody, IFA (Serum) Mycoplasma pneumoniae IgM Antibody, IFA (Serum) Mycoplasma pneumoniae IgG and IgM Antibody, IFA (Serum) Specimen Requirements: Specimen Stability: 1 ml (0.2 ml min.) serum Room temperature: 7 days Mycoplasma pneumoniae IgG and IgM Antibody, IFA (CSF) Test Code: Specimen Requirements: Add to acceptable specimens: 1 ml (0.2 ml) CSF Specimen Stability: Room temperature: unacceptable Measles (Rubeola) IgG AB, IFA (CSF) Measles (Rubeola) IgM AB, IFA (CSF) Measles (Rubeola) IgG and IgM Antibody Panel, IFA (CSF) Specimen Requirements: Specimen Stability: 1 ml (0.075 ml min.) CSF Room temperature: unacceptable Focus Diagnostics Page 10 of 11 December 2011

11 Toxoplasma gondii DNA, Qualitative Real-Time PCR Test Code: Specimen Requirements: Add to acceptable specimens: 1 ml (0.3 ml) amniotic fluid supernatant Ehrlichia chaffeensis DNA Real-Time PCR Test Code: Specimen Requirements: Add to acceptable specimens: 1 ml (0.3 ml) CSF For questions or additional information, please contact the Focus Diagnostics Client Services Department at (800) Visit our web site at for a listing of new tests and test updates. Focus Diagnostics Page 11 of 11 December 2011