Microsoft word - focus test update october 2009.doc
October 2009 TEST UPDATES This summary of test updates includes details and effective dates for new tests, changes to existing tests, and discontinued tests. For questions or additional information, please contact the Focus Diagnostics Client Services Department at (800) 445-4032. Visit our web site at www.focusdx.com. TABLE OF CONTENTS NEW TESTS Test Code Test Name Effective Date
Antimicrobial Level, Sulfamethoxazole, HPLC
TEST CHANGES Mycoplasma Comprehensive CultureM. avium Complex MIC PanelM. avium Complex MIC and Drug Combinations
DISCONTINUED TESTS
Antimicrobial Serum Level, Sulfamethoxazole, SP
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 payer being billed. Focus Diagnostics requires a current email 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 email address. Call (800) 445-4032 or email ClientServices@focusdx.com. Focus Diagnostics NEW TESTS Antimicrobial Level, Sulfamethoxazole, HPLC Effective Date: Available Now Unit Code: CPT Code: List Price: Specimen Requirements: 2 mL serum Transport Temperature: Specimen Stability: Room temperature: Unacceptable Refrigerated: Unacceptable Frozen: 14 days Reference Range: <5.0 mcg/mL Methodology: HPLC Set-up Day(s): Monday and Thursday Results Available: 2 to 5 days FDA clearance type: Laboratory Developed Test NYSDOH Approved: Performing Site: Focus Diagnostics, Inc. Additional Information: New Test Always message will be: Sulfamethoxazole peak levels occur approximately 1 - 4 hours after oral dosing with or without food. Minimal steady-state level (3 days): 57.4-68.0 mcg/mL CPU Interface Mapping: Test Code (analyte) Test Code Title Sulfamethoxazole Level, HPLC Brucella Antibody, Agglutination Effective Date: Available Now Unit Code: CPT Code: List Price: Specimen Requirements: 0.5 mL serum Transport Temperature: Room temperature Specimen Stability: Room temperature: 7 days Refrigerated: 14 days Frozen: 30 days Reference Ranges: <1:80 Methodology: DA Focus Diagnostics NEW TESTS Set-up Day(s): Monday, Tuesday and Wednesday Results Available: 2 to 8 days FDA clearance type: NYSDOH Approved: Performing Site: Focus Diagnostics, Inc. Additional Information: New Test Always message will be: Reference Range: <1:80 The most reliable serologic indicator of brucellosis is a four-fold increase in antibody titer when testing acute and convalescent sera in parallel. In the absence of paired sera, a single specimen titer of 1:80 or greater is consistent with brucellosis in a patient with a compatible clinical history. CPU Interface Mapping: Test Code (analyte) Test Code Title Brucella antibody titer Interferon Beta 1a (IFNB-1a) AB Effective Date: Available Now Unit Code: CPT Code: List Price: Specimen Requirements: 1 mL serum Transport Temperature: Room Temperature Specimen Stability: Room temperature: 5 days Refrigerated: 14 days Frozen: 30 days Reference Range: <1:20 Methodology: Tissue Culture/Neutralization Set-up Day(s): Monday or Tuesday Results Available: 5 to 14 days FDA clearance type: Laboratory Developed Test NYSDOH Approved: Performing Site: Focus Diagnostics, Inc. Additional Information: New Test Always message will be:
Focus Diagnostics NEW TESTS REFERENCE RANGE: <1:20 INTERPRETIVE CRITERIA: <1:20 Negative > or = 1:20 - <1:100 Elevated NAbs > or = 1:100 Highly Elevated NAbs Highly elevated NAbs (>=1:100) have been reported to correlate with predictable loss of interferon-beta bioactivity. In patients with elevated NAb levels from >=1:20 to <1:100, interferon-beta bioactivity may still be present, but does not correlate to the exact NAb titer and continued patient monitoring may be warranted. There is no apparent loss of interferon-beta bioactivity in patients who test positive in the binding antibody assay, but negative for NAbs; however, continued patient monitoring may also be warranted in this instance as well. CPU Interface Mapping: Test Code (analyte) Test Code Title IFNB 1a Neutralizing AB titer Interpretation Interferon Beta 1b (IFNB-1b) AB Effective Date: Available Now Unit Code: CPT Code: List Price: Specimen Requirements: 1 mL serum Transport Temperature: Room Temperature Specimen Stability: Room temperature: 5 days Refrigerated: 14 days Frozen: 30 days Reference Range: <1:20 Methodology: Tissue Culture/Neutralization Set-up Day(s): Monday or Tuesday Results Available: 5 to 14 days FDA clearance type: Laboratory Developed Test NYSDOH Approved: Performing Site: Focus Diagnostics, Inc. Additional Information: New Test Always message will be: REFERENCE RANGE: <1:20
Focus Diagnostics NEW TESTS INTERPRETIVE CRITERIA: <1:20 Negative > or = 1:20 - <1:100 Elevated NAbs > or = 1:100 Highly Elevated NAbs Highly elevated NAbs (>=1:100) have been reported to correlate with predictable loss of interferon-beta bioactivity. In patients with elevated NAb levels from >=1:20 to <1:100, interferon-beta bioactivity may still be present, but does not correlate to the exact NAb titer and continued patient monitoring may be warranted. There is no apparent loss of interferon-beta bioactivity in patients who test positive in the binding antibody assay, but negative for NAbs; however, continued patient monitoring may also be warranted in this instance as well. CPU Interface Mapping: Test Code (analyte) Test Code Title IFNB 1b Neutralizing AB titer Interpretation Respiratory Virus PCR Panel II Effective Date: Available Now Unit Code: CPT Code: 87798 (x7) List Price: $1243.00 Specimen Requirements: Throat or nasopharyngeal swab in 3 mL M4 Media or V-C-M Medium (green-cap) tube or equivalent (UTM) or 1 mL nasopharyngeal aspirate or bronchial lavage/wash in a sterile leak-proof container. Transport Temperature: Refrigerated Specimen Stability: Room temperature: 48 hours Refrigerated: 7 days Frozen: 30 days Reference Range: Not Detected Methodology: Real-Time Set-up Day(s): Monday-Sunday Results Available: 1 to 3 days FDA clearance type: Laboratory Developed Test NYSDOH Approved: Performing Site: Focus Diagnostics, Inc. Additional Information: New Test This test was formerly available only as a custom test, 3018 Custom BAL Respiratory PCR Panel II. This test is now available as 3018 Respiratory Virus PCR Panel II and listed in our on-line test listing at Focus Diagnostics NEW TESTS www.focusdx.com. This panel includes: Influenza Type A and B RNA, Qualitative Real-Time RT-PCR Parainfluenza Virus (Types 1, 2, & 3) RNA, Qualitative Real-Time PCR RSV (Respiratory Syncytial Virus) RNA, Qualitative Real-Time PCR Human Metapneumovirus RNA, Qualitative Real-Time PCR See individual assays for always messages. Respiratory Virus PCR Panel III Effective Date: Available Now Unit Code: CPT Code: 87798 (x8) List Price: $1659.00 Specimen Requirements: Throat or nasopharyngeal swab in 3 mL M4 Media or V-C-M Medium (green-cap) tube or equivalent (UTM) or 1 mL nasopharyngeal aspirate or bronchial lavage/wash in a sterile leak-proof container. Transport Temperature: Refrigerated Specimen Stability: Room temperature: 48 hours Refrigerated: 7 days Frozen: 30 days Reference Range: Not Detected Methodology: Real-Time PCR/Real-Time Set-up Day(s): Monday-Sunday Results Available: 1 to 3 days FDA clearance type: Laboratory Developed Test NYSDOH Approved: Performing Site: Focus Diagnostics, Inc. Additional Information: New Test This test was formerly available only as a custom test, 49990 Custom Respiratory Virus Panel, Qualitative Real-Time PCR. This test is now available as 49990 Respiratory Virus PCR Panel III and listed in our on-line test listing at www.focusdx.com. Always message will be:
REFERENCE RANGE: NOT DETECTED This test was developed and its performance characteristics have been Focus Diagnostics NEW TESTS determined by Focus Diagnostics. Performance characteristics refer to the analytical performance of the test. This test is performed pursuant to a license agreement with Roche Molecular Systems, Inc. and ViroNovative BV. CPU Interface Mapping: Test Code (analyte) Test Code Title 100 (ask at order entry (prompt)) RSV RNA, Qualitative PCR Influenza A RNA, PCR Influenza B RNA, PCR Parainfluenza 1 RNA Parainfluenza 2 RNA Parainfluenza 3 RNA Adenovirus DNA, QL PCR hMPV RNA, QL PCR Focus Diagnostics TEST CHANGES
The following section contains updates to existing tests. For complete test information, contact Client Services at 800-445-4032 or visit our website at www.focusdx.com.
Respiratory Virus PCR Panel I Effective Date: November 9, 2009 Unit Code: Former Test Name:
Respiratory Virus Panel, Qualitative Real-Time PCR
Additional Information: Mycoplasma Comprehensive Culture Effective Date: December 14, 2009 Unit Code: Former Test Name:
Mycoplasma Culture, Fastidious Pathogens
Transport Temperature: Frozen (room temperature whole blood only) Specimen Stability: Room temperature: Unacceptable (24 hours whole blood only) Refrigerated: 48 hours (do not refrigerate whole blood) Frozen: 30 days (do not freeze whole blood) Additional Information: Update reporting title, transport temperature, specimen stability, and always message. Always message will be: Mycoplasma species other than M. pneumoniae and M. hominis, and Ureaplasma urealyticum are reported but not speciated. The absence of isolation of a Mycoplasma or Ureaplasma does not rule out the potential presence in the specimen. Due to the fastidious nature of these organisms, negative cultures may be obtained. Sound clinical judgment is always recommended. M. avium Complex MIC Panel Effective Date: December 23, 2009 Unit Code: Additional Information: Update CPU interface mapping. Add 776 Ethionamide and 777 Isoniazid. CPU Interface Mapping: Test Code (analyte) Test Code Title Focus Diagnostics TEST CHANGES Ethionamide Isoniazid M. avium Complex MIC and Drug Combinations Effective Date: December 23, 2009 Unit Code: Additional Information: Update CPU interface mapping for the MAC MIC part of profile. Add 3776 Ethionamide and 3777 Isoniazid. CPU Interface Mapping: Test Code (Analyte) Test Code Title Ethionamide Isoniazid Mycobacterium Slow Grower MIC Effective Date: December 23, 2009 Unit Code: Additional Information: Update CPU interface mapping for the MAC MIC part of profile. Add 511 Doxycycline, 512 Ethionamide and 513 Isoniazid. Remove 505 Minocycline. CPU Interface Mapping: Test Code (Analyte) Test Code Title Doxycycline Ethionamide Isoniazid Focus Diagnostics TEST CHANGES Focus Diagnostics DISCONTINUED TESTS Antimicrobial Serum Level, Sulfamethoxazole, SP Effective Date: December 14, 2009 Unit Code: Additional Information: This test will be discontinued. Please order 51526 Antimicrobial Level, Sulfamethoxazole, HPLC. See test information in the New Test section of this document.
For questions or additional information, please contact the Focus Diagnostics Client
Services Department at (800) 445-4032. Visit our web site at www.focusdx.com for a
Focus Diagnostics
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