ࡱ> _ Cbjbj;`;` 8 ' HHz%J I yN  > V: As an Interpath customer who receives electronic results or sends electronic orders you may need to be notified when we update our Service Manual. Although we try to keep these changes to a minimum, laboratory medicine is an evolving industry requiring changes to our technology from time to time. Depending on the requirements of your EMR or Hospital Information System you may be required to make similar changes to your system in order to correctly process inbound electronic results and create outbound electronic orders. If you are uncertain that you are required to update your system we recommend that you contact your vendor for more information. As your laboratory service provider we are available to participate in the discussion with your vendor so that you clearly understand the impact of these changes. Included in this email: This cover letter with a summary of the changes Microsoft Word Document with the detail of these changes to our Service Manual Additional information including our most recent Service Manual and additional contact information can be found at  HYPERLINK "http://www.interpathlab.com" www.interpathlab.com Effective Date: July 17, 2017  In an effort to provide better and more comprehensive laboratory services to our clients regarding our autoimmune disease testing menu, we are pleased to announce our transition to a new test system vendor, Inova Diagnostics. Inova Diagnostics specializes in autoimmune technologies and diagnostic markers and will be an ideal partner as we seek to enlarge our autoimmune disease testing footprint. Due to the complex nature of this transition, we will be transitioning our testing in three phases, the first commencing today (July 17th, 2017). We appreciate your patience as we make these exciting changes. NCCCCPTSRCRRCNTDTAOEName ChangeComponent ChangeCPT ChangeSpecimen Requirements ChangeReference Range ChangeNew TestDiscontinued TestAsk on Order Entry QuestionsOrder CodeTest Name2313Anti-Nuclear Antibody((2500Anti-Nuclear Antibody w/Reflex((1443Autoimmune Panel(((2600dsDNA (Double Stranded DNA) Antibody((2601dsDNA (Double Stranded DNA) Ab Titer(2372ENA Antibody((2333Mitochondrial Antibody((2359Parietal Cell Antibody((2349Smooth Muscle Antibody((2365Sm/RNP Antibody((( 2313Anti-Nuclear Antibody SRC/CPTSpecimen:Collect:One SST Also Acceptable One Red TopSubmit:1 mL (Min:0.5 mL) Serum. Submit Refrigerated. Submit in a Standard Transport Tube. Special Handling:Separate from cells ASAPRejection Criteria:Grossly Hemolyzed Samples Grossly Lipemic Samples Heat inactivated Microbial Contamination Particulate matterStability:Ambient: 8 Hour(s); Refrigerated: 2 Day(s); Frozen: 1 Month(s); Incubated: UnacceptableMethodology: Indirect Fluorescent Antibody (IFA)Performed: Monday, Tuesday, Wednesday, ThursdayReported: 1-4 Day(s) Positive Results will be titered and reported next day.CPT Codes: 86039 Interpretive Data: Please see report for interpretive data.Components: 2312 - ANA TITER 2301 - ANA PATTERN Please take note of changes to methodology, special handling, rejection criteria, stability, CPT code and days performed. 2500Anti-Nuclear Antibody w/Reflex SRC/CPTSpecimen:Collect:One SST Also Acceptable One Red TopSubmit:3 mL (Min:2 mL) Serum. Submit Refrigerated. Submit in a Standard Transport Tube. Special Handling:Separate from cells ASAP If positive, the following EIA tests will be performed: Centromere Antibody Jo-1 Antibody RNP Antibody DNA Antibody Scleroderma Antibody Smith Antibody Histone Antibody Sjogren Antibodies A & B Positive Anti-DNA confirmed with Crithidae Additional charges will apply.Rejection Criteria:Grossly Hemolyzed Samples Grossly Lipemic Samples Heat inactivated Microbial Contamination Particulate matterStability:Ambient: 8 Hour(s); Refrigerated: 2 Day(s); Frozen: 1 Month(s); Incubated: UnacceptableMethodology: See Individual ComponentsPerformed: Monday, Tuesday, Wednesday, ThursdayReported: 1-4 Day(s) Positive Results will be titered and reported next day.CPT Codes: 86039 Interpretive Data: Please see report for interpretive data.Components: 2312 - ANA TITER 2301 - ANA PATTERN 2510 - ANA REFLEX Please take note of changes to methodology, special handling, rejection criteria, stability, CPT code and days performed. 1443Autoimmune Panel SRC/RRC/CPTSpecimen:Collect:One SST Also Acceptable One Red TopSubmit:2 mL (Min:1 mL) Serum. Submit Refrigerated. Submit in a Standard Transport Tube. Special Handling:Allow specimen to clot completely at room temperature Avoid Repeated Freeze/Thaw Cycles Separate from cells ASAP If the dsDNA Antibody is Positive, then the dsDNA AB Titer (Test# 2601) will be performed. Additional charges will apply. Rejection Criteria:Grossly Hemolyzed Samples Heat inactivated Lipemic Samples Microbial Contamination Particulate matterStability:See Individual ComponentsMethodology: See Individual ComponentsPerformed: Monday, Wednesday, FridayReported: 2-3 Day(s) Positive Results will be titered and reported next day. Positive Anti DNA is confirmed with Crithidae.CPT Codes: 83520 86039 86140 86235 86255 86431 86160x2 86235x6 Interpretive Data: Please see report for interpretive data.Components: 2312 - ANA TITER 2301 - ANA PATTERN 2600 - dsDNA ANTIBODY 2366 - SMITH AB 2365 - SM/RNP AB 2367 - SJOGRENS A AB 2368 - SJOGRENS B AB 2331 - CENTROMERE AB 2369 - SCLERODERMA AB 2337 - RHEUMATOID FACTOR 2320 - C-REACTIVE PROT 2356 - COMPLEMENT C3 2357 - COMPLEMENT C4 2393 - JO-1 AB 2399 - HISTONE AB Please take note to specimen requirement change, reference range, and CPT code changes. dsDNA Ab Reference Range: <30 IU/mL Negative 30-75 IU/mL Equivocal >75 IU/mL Positive Smith Ab, Sjogrens A Ab, Sjogrens B Ab, and JO-1 Ab Reference Range: <20 EU Negative 20-25 EU Inconclusive >25 EU Positive Histone Ab Reference Range: <1.0 U/mL Normal 1.0-1.5 U/mL Weak Positive 1.6-2.5 U/mL Moderate Positive >2.5 U/mL Strong Positive Sm/RNP Ab Reference Range: <20 Units Negative 20-39 Units Weak Positive 40-80 Units Moderate Positive >80 Units Strong Positive A positive Sm/RNP Ab result indicates the presence of antibodies reactive with the Smith (Sm) protein and/or ribonuclear protein (RNP). This Sm/RNP assay cannot distinguish between Anti-Sm and Anti-RNP activity, thus should be considered with the Sm Ab test result to determine clinical significance. An ANA TITER of 1:160 or less may be seen in up to 4% of apparently healthy individuals, increasing in incidence with aging. These results should be considered in the context of clinical findings and criteria established by the American College of Rheumatology. 2600dsDNA (Double Stranded DNA) Antibody RRC/SRCSpecimen:Collect:One SST Also Acceptable One Red TopSubmit:1 mL (Min:0.5 mL) Serum. Submit Refrigerated. Submit in a Standard Transport Tube. Special Handling:Allow specimen to clot completely at room temperature Avoid Repeated Freeze/Thaw Cycles Separate from cells ASAP If the dsDNA Antibody is Positive, then the dsDNA AB Titer (Test# 2601) will be performed. Additional charges will apply. The reflex assay is only stable 2 days refrigerated.Rejection Criteria:Grossly Hemolyzed Samples Heat inactivated Lipemic Samples Microbial Contamination Particulate matterStability:Ambient: Unacceptable; Refrigerated: 7 Day(s); Frozen: 1 Month(s); Incubated: UnacceptableMethodology: Enzyme-Linked ImmunoSorbent Assay (ELISA)Performed: Monday, Wednesday, ThursdayReported: 1-4 Day(s) Positive results are confirmed with a titer the next testing day.CPT Codes: 86235 Interpretive Data: Please take note of changes to reference range, methodology, LOINC code (see attached compendium), special handling, rejection criteria, stability, and days performed. dsDNA Ab Reference Range: <30 IU/mL Negative 30-75 IU/mL Equivocal >75 IU/mL Positive 2601dsDNA (Double Stranded DNA) Antibody Titer SRCSpecimen:Collect:One SST Also Acceptable One Red TopSubmit:1 mL (Min:0.5 mL) Serum. Submit Refrigerated. Submit in a Standard Transport Tube. Special Handling:Separate from cells ASAP This is the reflex from dsDNA (Double Stranded DNA) Antibody.Rejection Criteria:Grossly Hemolyzed Samples Heat inactivated Lipemic Samples Microbial Contamination Particulate matterStability:Ambient: 8 Hour(s); Refrigerated: 2 Day(s); Frozen: 1 Month(s); Incubated: UnacceptableMethodology: Indirect Fluorescent Antibody (IFA)Performed: Tuesday, Thursday, FridayReported: 2-4 Day(s)CPT Codes: 86256 Interpretive Data:  DNA Antibodies are screened using an ELISA assay. Positive results are titered by IFA. A result of 'None Detected' correlates with an IFA titer of <1:10. Please take note of changes to LOINC code (see attached compendium), special handling, rejection criteria, stability, and days performed. 2372ENA Antibody RRC/SRCSpecimen:Collect:One SST Also Acceptable One Red TopSubmit:2 mL (Min:1 mL) Serum. Submit Refrigerated. Submit in a Standard Transport Tube. Special Handling:Separate from cells ASAPRejection Criteria:Grossly Hemolyzed Samples Grossly Lipemic Samples Heat inactivated Microbial Contamination Particulate matterStability:Ambient: 8 Hour(s); Refrigerated: 2 Day(s); Frozen: 1 Month(s); Incubated: UnacceptableMethodology: Enzyme-Linked ImmunoSorbent Assay (ELISA)Performed: Monday, Wednesday, ThursdayReported: 1-4 Day(s)CPT Codes: 86235x2 Interpretive Data: Please see report for interpretive data.Components: 2366 - SMITH AB 2365 - SM/RNP AB Please take note to specimen requirement and reference changes. Reference Range for Smith Ab: <20 EU Negative 20-25 EU Inconclusive >25 EU Positive Sm/RNP Ab Reference Range: <20 Units Negative 20-39 Units Weak Positive 40-80 Units Moderate Positive >80 Units Strong Positive A positive Sm/RNP Ab result indicates the presence of antibodies reactive with the Smith (Sm) protein and/or ribonuclear protein (RNP). This Sm/RNP assay cannot distinguish between Anti-Sm and Anti-RNP activity, thus should be considered with the Sm Ab test result to determine clinical significance. 2333Mitochondrial Antibody RRC/SRCSpecimen:Collect:One SST Also Acceptable One Red TopSubmit:1 mL (Min:0.5 mL) Serum. Submit Refrigerated. Submit in a Standard Transport Tube. Special Handling:Separate from cells ASAPRejection Criteria:Grossly Hemolyzed Samples Grossly Lipemic Samples Heat inactivated Microbial Contamination Particulate matterStability:Ambient: 8 Hour(s); Refrigerated: 2 Day(s); Frozen: 1 Month(s); Incubated: UnacceptableMethodology: Indirect Fluorescent Antibody (IFA)Performed: Monday, WednesdayReported: 1-5 Day(s)CPT Codes: 86255 Interpretive Data: General Reference Range : <1:40 Please take note of changes to reference range, methodology, LOINC code (see attached compendium), special handling, rejection criteria, stability, and days performed. 2359Parietal Cell Antibody RRC/SRCSpecimen:Collect:One SST Also Acceptable One Red TopSubmit:2 mL (Min:1 mL) Serum. Submit Refrigerated. Submit in a Standard Transport Tube. Special Handling:Separate from cells ASAPRejection Criteria:Grossly Hemolyzed Samples Grossly Lipemic Samples Heat inactivated Microbial Contamination Particulate matterStability:Ambient: 8 Hour(s); Refrigerated: 2 Day(s); Frozen: 1 Month(s); Incubated: UnacceptableMethodology: Indirect Fluorescent Antibody (IFA)Performed: Monday, WednesdayReported: 1-5 Day(s)CPT Codes: 86255 Interpretive Data: General Reference Range : <1:40 Please take note of changes to reference range, methodology, special handling, rejection criteria, stability, and days performed. 2349Smooth Muscle Antibody RRC/SRCSpecimen:Collect:One SST Also Acceptable One Red TopSubmit:1 mL (Min:0.5 mL) Serum. Submit Refrigerated. Submit in a Standard Transport Tube. Special Handling:Separate from cells ASAPRejection Criteria:Grossly Hemolyzed Samples Grossly Lipemic Samples Heat inactivated Microbial Contamination Particulate matterStability:Ambient: 8 Hour(s); Refrigerated: 2 Day(s); Frozen: 1 Month(s); Incubated: UnacceptableMethodology: Indirect Fluorescent Antibody (IFA)Performed: Monday, WednesdayReported: 1-5 Day(s)CPT Codes: 86255 Interpretive Data: General Reference Range : <1:40 Please take note of changes to reference range, methodology, LOINC code (see attached compendium), special handling, rejection criteria, stability, and days performed. 2365Sm/RNP Antibody NC/RRC/SRCSpecimen:Collect:One SST Also Acceptable One Red TopSubmit:2 mL (Min:1 mL) Serum. Submit Refrigerated. Submit in a Standard Transport Tube. Special Handling:Separate from cells ASAPRejection Criteria:Grossly Hemolyzed Samples Grossly Lipemic Samples Heat inactivated Microbial Contamination Particulate matterStability:Ambient: 8 Hour(s); Refrigerated: 2 Hour(s); Frozen: 1 Month(s); Incubated: UnacceptableMethodology: Enzyme-Linked ImmunoSorbent Assay (ELISA)Performed: Monday, Wednesday, ThursdayReported: 1-4 Day(s)CPT Codes: 86235 Interpretive Data:  Please take note of changes to reference range, methodology, LOINC code (see attached compendium), special handling, rejection criteria, stability, and days performed. Sm/RNP Ab Reference Range: <20 Units Negative 20-39 Units Weak Positive 40-80 Units Moderate Positive >80 Units Strong Positive A positive Sm/RNP Ab result indicates the presence of antibodies reactive with the Smith (Sm) protein and/or ribonuclear protein (RNP). This Sm/RNP assay cannot distinguish between Anti-Sm and Anti-RNP activity, thus should be considered with the Sm Ab test result to determine clinical significance. Please Note: This test is not orderable by itself but is contained in the following panels: 1443 Autoimmune Panel, 2372 ENA Antibody, and 1445 Positive ANA Reflex Panel.     Interpath Laboratory, Inc. 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