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 Culture M. avium Complex MIC Panel M. 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 [email protected].
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

Source: http://www.focusdx.com/focus/1-reference_laboratory/test_updates/Focus_Test_Updates_October_2009.pdf