December Monthly Update, Quest Diagnostics Nichols Institute, Valencia

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1 December Monthly Update, NEW TESTS Please Note: Not all test codes assigned to each assay are listed in the table of contents. Please refer to the complete listing on the page numbers indicated. Test Code Test Name Effective Date Page # Dengue Fever Antibodies (IgG, IgM) 1/11/ Dengue Fever Antibodies (IgG, IgM) and NS1 Antigen Panel 1/11/ Dengue Virus NS1 Antigen 1/11/ Prostate Specific Antigen (PSA), Total, 2.5 ng/ml Cutoff 1/11/ Aeromonas and Plesiomonas Culture, Stool 1/18/ TEST CHANGES Please Note: Not all test codes assigned to each assay are listed in the table of contents. Please refer to the complete listing on the page numbers indicated. Test Code Former Test Code Test Name Effective Date Page # 237 [3109] Alpha Fetoprotein, Tumor Marker 1/11/ [5313] Bilirubin, Fractionated 1/11/ [7533] B-Type Natriuretic Peptide (BNP) 1/11/ [3258] CEA 1/11/2016 S51387 CEA with HAMA Treatment 1/11/ [A49042] Dengue Fever Antibody (IgG) 1/11/ [S49605] Dengue Fever Antibody (IgM) 1/11/ [3351] Direct LDL 1/11/ [3934] Fructosamine 1/11/ [3174] FSH (Follicle Stimulating Hormone) 1/11/ [5318] Hepatic Function Panel 1/11/2016 [2016] Infertility: Endocrine Evaluation (Female) 1/11/ [3454] Lipid Panel 1/11/ [3206] Prolactin 1/11/ Protein, Total, Serum 1/11/2016 [3546SR] PSA (Prostate-Specific Antigen) with Serial Reporting 1/11/ [3546] PSA, Total 1/11/ [3547] PSA, Free and Total 1/11/ [S49587] PSA, Post Prostatectomy 1/11/ [3944] PTH, Intact (ICMA) and Ionized Calcium 1/11/ [3941] PTH, Intact (without Calcium) 1/11/ [3943] PTH, Intact and Calcium 1/11/2016 [RNQ] Reflex PSA (Prostate-Specific Antigen, Free and Total) 1/11/ Sex Hormone Binding Globulin 1/11/ Page 1 of 34 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.

2 December Monthly Update, Thyroglobulin Panel 1/11/ Quantitative Thyroglobulin without Thyroglobulin Antibodies 1/11/ [3228] T4, Free 1/11/ Thyroid Cancer (Thyroglobulin) Monitoring 1/11/ TSH 1/11/ Chromosomal Microarray, Prenatal, ClariSure Oligo-SNP 1/18/ [1535] C-Reactive Protein (CRP) 1/18/ [3133] Cyclic Citrullinated Peptide (CCP) Antibody (IgG) 1/18/ [2450] Hepatitis A Antibody, Total 1/18/ [2477] Hepatitis A Antibody, Total with Reflex to IgM 1/18/ hs-crp 1/18/ [1506] IgA 1/18/ Immunoglobulins Panel, Serum 1/18/ Lyme Disease Antibodies (IgG, IgM), Immunoblot 1/18/ Lyme Disease Antibody with Reflex to Blot (IgG, IgM) 1/18/ [9716] Mumps Virus Antibody (IgG) 1/18/ Rheumatoid Arthritis Diagnostic Panel IdentRA(TM) with eta 1/18/ Bacterial Vaginosis/Vaginitis Panel 1/25/ Chlamydia trachomatis RNA, TMA 1/25/ Neisseria gonorrhoeae RNA, TMA 1/25/ Chlamydia/Neisseria gonorrhoeae RNA,TMA 1/25/ SureSwab, Vaginosis/Vaginitis Plus 1/25/ Hepatitis B Virus DNA, Quantitative, Real-Time PCR 1/25/ Hepatitis C Viral RNA, Genotype, LiPA 1/25/ Hepatitis C Viral RNA, Quantitative, Real-Time PCR 1/25/ HIV-1 RNA, Quantitative PCR with Reflex to Genotype 1/25/ HIV-1 RNA, Quantitative, Real-Time PCR 1/25/ [1821] HPV DNA, High Risk 1/25/ HPV Genotypes 16, 18/45 1/25/ HPV mrna E6/E7 1/25/ [3496] Methylmalonic Acid 1/25/ REDIRECTS Please Note: Not all test codes assigned to each assay are listed in the table of contents. Please refer to the complete listing on the page numbers indicated. Test Code Former Test Code Test Name Effective Date Page # Cervical Cancer, TERC, FISH 1/18/ DISCONTINUED TESTS Please Note: Not all test codes assigned to each assay are listed in the table of contents. Please refer to the complete listing on the page numbers indicated. Page 2 of 34

3 December Monthly Update, Test Code Test Name Effective Date Page # [3218] Sex Hormone Binding Globulin (SHBG) 1/11/ Bisphenol A and Creatinine, Random Urine 1/18/ Hepatitis B Virus DNA, Quantitative, Real-Time PCR 1/25/ A HIV-1 RNA, Quantitative, Real-Time PCR 1/25/ SEND OUTS Please Note: Not all test codes assigned to each assay are listed in the table of contents. Please refer to the complete listing on the page numbers indicated. Test Code Former Test Code Test Name Effective Date Page # Bisphenol A-Total (Conjugated/Unconjugated), Urine 1/18/ Re: 2016 AMA CPT Code Changes The American Medical Association (AMA) has made Current Procedural Terminology (CPT) code changes to the 2016 edition of the CPT coding manual. Quest Diagnostics will be implementing these changes effective January 1, In September 2015, CMS announced the possible adoption of new G codes for toxicology and deletion of the G codes which existed for We will be updating our systems when their decision is finalized. CPT 2016 changes involve a new AMA Panel Obstetric Panel (includes HIV testing), a few new molecular testing codes, new GSP codes, changes to Tier 2 molecular codes, additional MAAA tests, and deletion of several methodology CPT codes in the Chemistry section. Additional detailed information will be available on our website. If you need additional information, please refer to the 2016 AMA CPT Code book or the Quest Diagnostics website We appreciate your support and look forward to continuing to serve all of your laboratory needs. Quest Diagnostics will make every effort to assist our clients with the transition to the 2016 AMA CPT coding being used for our test offerings. New Test Offerings The following tests will be available through Quest Diagnostics on the dates indicated below. Dengue Fever Antibodies (IgG, IgM) Clinical Significance Dengue hemorrhagic fever and Dengue shock syndrome are caused by infection of the RNA flavivirus transmitted by a mosquito vector. Paired acute and convalescent specimens that exhibit a significant change in titer are useful to confirm clinical diagnosis of infection. Test Code CPT Codes (x2) 1 ml (0.5 ml minimum) serum See individual assays 7 days 14 days 30 days Set-up/Analytic Time Set up: Tues-Sat; Report available: 1-3 days Page 3 of 34

4 December Monthly Update, Result Name Dengue Fever Ab (IgG) <0.90 Dengue Fever Ab (IgM) <0.90 Immunoassay Focus Diagnostics, Inc Dengue Fever Ab (IgG) Dengue Fever Ab (IgG) Dengue virus Ab.IgG Dengue Fever Ab (IgM) Dengue Fever Ab (IgM) Dengue virus Ab.IgM Dengue Fever Ab (IgG) Dengue virus Ab.IgG Dengue Fever Ab (IgM) Dengue virus Ab.IgM Dengue Fever Antibodies (IgG, IgM) and NS1 Antigen Panel Message Clinical Significance Includes: Dengue Virus NS1 Antigen * Dengue Fever Antibody (IgG) * Dengue Fever Antibody (IgM) NS1 antigen detection can serve as an effective bridge between dengue RNA detection (usually negative by day 5) and dengue IgM detection (may not be positive until day 6) for identifying acute dengue virus infection. Test Code CPT Codes 87449, (x2) 1.5 ml (0.6 ml minimum) serum See individual assays 7 days 14 days 30 days Set-up/Analytic Time See individual assays Result Name NS1 Antigen Index <1.00 Dengue Fever Ab (IgG) <0.90 Dengue Fever Ab (IgM) <0.90 Immunoassay Focus Diagnostics, Inc. Page 4 of 34

5 December Monthly Update, NS1 Antigen Index Dengue virus NS1 Ag Dengue Fever Ab (IgG) Dengue virus Ab.IgG Dengue Fever Ab (IgM) Dengue virus Ab.IgM Dengue Virus NS1 Antigen Clinical Significance Dengue NS1 antigen is found in serum during the acute phase of dengue virus infection, typically during days 1-9 after onset of symptoms. NS1 antigen may be positive when RNA and/or IgM detection assays are negative. Test Code CPT Codes ml (0.1 ml minimum) serum 7 days 14 days 30 days Set-up/Analytic Time Set-up: Mon-Thurs; Report available: 1-5 days Result Name NS1 Antigen Index <1.00 Immunoassay Focus Diagnostics, Inc NS1 Antigen Index Dengue virus NS1 Ag Prostate Specific Antigen (PSA), Total, 2.5 ng/ml Cutoff Clinical Significance Elevated serum PSA concentrations have been reported in men with prostate cancer, benign prostatic hypertrophy, and inflammatory conditions of the prostate. Test Code CPT Codes Instructions 1 ml (0.5 ml minimum) serum Do not collect specimen after a transrectal biopsy, results may be falsely elevated. 7 days 14 days 28 days Page 5 of 34

6 December Monthly Update, Set-up/Analytic Time Set up: Tues, Thurs, Sat; Report available: 1-2 days Result Name Gender Unit Of Measure PSA,Total,2.5ng/mL Cutoff Male < or = 2.5 ng/ml PSA,Total,2.5ng/mL Cutoff Female Not established Males: < or = 2.5 ng/ml Immunoassay PSA,Total,2.5ng/mL cutoff Prostate specific Ag Aeromonas and Plesiomonas Culture, Stool Clinical Significance Infection with Aeromonas spp. can result in a mild, self-limiting diarrheal disease as well as a spectrum of intestinal diseases ranging from acute dysentery to chronic watery diarrhea persisting for weeks or months. Aeromonas spp. can cause acute diarrhea in children and traveler's diarrhea in adults. Sources of infection are commonly found to include exposure to freshwater sources or many cold- and warmblooded vertebrates. Effective Date 1/18/2016 Test Code CPT Codes Plesiomonas shigelloides is a significant cause of both locally acquired and traveler's diarrhea that may respond to antimicrobial therapy. Infection with P. shigelloides can result in gastrointestinal disturbances, typically presenting as either a secretory diarrhea or colitis-like infection. Plesiomonads commonly are found in freshwater sources and colonizing or infecting reptiles and cold-blooded vertebrate such as lizards, snakes, and frogs.? Instructions 5 gm (1 g minimum) stool collected in Cary-Blair stool culture transport medium Received refrigerated; received frozen Pass stool into a clean, dry container; then, transfer to enteric transport medium. Rectal swabs are less reliable for detecting enteric pathogens. 4 days Unacceptable Unacceptable Set-up/Analytic Time Set up: Mon, Wed, Fri; Report available: 1-3 days Result Name Aeromonas,Plesiomonas Cult Not isolated Culture Page 6 of 34

7 December Monthly Update, Aeromonas,Plesiomonas Cult Aeromonas sp Additional Information If culture is positive, an identification will be performed at an additional charge (CPT code (s): or or or 87149). Antibiotic susceptibilities are only performed when appropriate (CPT code(s): 87181, 87184, 87185, 87186). Test Changes The following test changes will be effective on the dates indicated below. Please note information that is changing appears in bold text in this update. Former test names and test codes have been italicized. Alpha Fetoprotein, Tumor Marker Message ** This test is not available for New York patient testing.** Former Test Name Alpha-Fetoprotein, (AFP) Tumor Marker Former Test Code [3109] Test Code ml serum Result Name Age Gender Unit Of Measure AFP, Tumor Marker <1 Month* Male *Pediatric range is based on full term neonates, values for premature infants may be higher. ng/ml AFP, Tumor Marker <1 Month* Female *Pediatric range is based on full term neonates, values for premature infants may be higher. ng/ml AFP, Tumor Marker AFP, Tumor Marker AFP, Tumor Marker AFP, Tumor Marker 1-11 Months 1-11 Months 1-3 Years 1-3 Years Male ng/ml Female ng/ml Male ng/ml Female ng/ml AFP, Tumor Marker >3 Years Male <6.1 ng/ml AFP, Tumor Marker >3 Years Female <6.1 The use of AFP as a tumor marker in pregnant females is not recommended. ng/ml Immunoassay AFP, Tumor Marker Alpha-1-Fetoprotein.tumor marker Pricing Message Negotiated pricing on [3109] will be applied to code 237. Page 7 of 34

8 December Monthly Update, [3028] Alpha-Fetoprotein & Human Chorionic Gonadotropin [3028SR] [3109SR] Alpha-Fetoprotein & Human Chorionic Gonadotropin w/serial Reporting Alpha-Fetoprotein (AFP) Tumor Marker w/serial Reporting Bilirubin, Fractionated Former Test Name Bilirubin, Total and Direct Former Test Code [5313] Test Code 7286 Instructions Hemolysis; anticoagulants other than heparin Protect from light, avoid hemolysis 24 hours* *if protected from light 72 hours* *if protected from light 90 days* * if protected from light Result Code Result Name Unit Of Measure LOINC Code Component Name Bilirubin, Total mg/dl Bilirubin Bilirubin, Direct mg/dl Bilirubin.glucuronidated+Bilirubin.albumin bound Bilirubin, Indirect mg/dl (calc) Bilirubin.non-glucuronidated Pricing Message Negotiated pricing on [5313], will be applied to code [3554] Bilirubin, Total [5317] Comprehensive Metabolic Panel B-Type Natriuretic Peptide (BNP) Former Test Code [7533] Test Code Instructions Collected in a glass tube; PPT potassium EDTA (white-top) tube Centrifuge tube and separate plasma into a plastic screw-cap vial within 1 hour. Freeze plasma immediately. Note: BNP is unstable in glass containers. Use of glass tubes and glass transfer pipettes will affect Page 8 of 34

9 December Monthly Update, accurate quantitation of BNP. and 1 hour 9 months Result Code Result Name Unit Of Measure LOINC Code Component Name B Type Natriuretic Peptide pg/ml Natriuretic peptide.b Pricing Message Negotiated pricing on [7533] will be applied to code CEA Former Test Code [3258] Test Code 978 and 7 days 28 days Result Code Result Name Unit Of Measure LOINC Code Component Name CEA ng/ml Carcinoembryonic Ag Pricing Message Negotiated pricing on [3258] will be applied to code 978. [S51387] - Mapping change does not apply to this test. [3258SR] - Mapping change does not apply to this test CEA with HAMA Treatment CEA with Serial Reporting [3254] - Mapping change does not apply to this test Small Cell Carcinoma Monitoring, Lung CEA with HAMA Treatment Test Code S51387 and 7 days 28 days Immunoassay Quest Diagnostics Nichols Institute, San Juan Capistrano Dengue Fever Antibody (IgG) Page 9 of 34

10 December Monthly Update, Former Test Name Former Test Code Dengue Fever IgG by EIA [A49042] Test Code Focus Diagnostics, Inc Dengue Fever Ab (IgG) Dengue virus Ab.IgG Pricing Message Negotiated pricing on [A49042] will be applied to code Dengue Fever Antibody (IgM) Former Test Name Former Test Code Dengue Fever IgM AB [S49605] Test Code Focus Diagnostics, Inc Dengue Fever Ab (IgM) Dengue virus Ab.IgM Pricing Message Negotiated pricing on [S49605] will be applied to code Direct LDL Former Test Code [3351] Test Code 8293 Result Code Result Name Unit Of Measure LOINC Code Component Name Direct LDL mg/dl Cholesterol.in LDL Pricing Message Negotiated pricing on [3351] will be applied to code Fructosamine Former Test Code [3934] Test Code 8340 Hemolysis, moderate or grossly icteric Serum 5 days Page 10 of 34

11 December Monthly Update, Serum 14 days Serum 60 days Plasma 72 hours Plasma 14 days Plasma 60 days Result Code Result Name Unit Of Measure LOINC Code Component Name Fructosamine umol/l Fructosamine Pricing Message Negotiated pricing on [3934] will be applied to code FSH (Follicle Stimulating Hormone) Former Test Name FSH, Serum Former Test Code [3174] Test Code 470 Instructions Note: For pre-pubertal children, test code A52225 FSH, Pediatrics assay is recommended and 7 days 28 days Result Code Result Name Unit Of Measure LOINC Code Component Name FSH miu/ml Follitropin Pricing Message Negotiated pricing on [3174] will be applied to code 470. [2020] Follicle Stimulating Hormone and Luteinizing Hormone Evaluation Hepatic Function Panel Message Includes: Protein, Total* Albumin* Globulin* Albumin/Globulin Ratio* Bilirubin, Total* Bilirubin, Direct* Bilirubin, Indirect* Alkaline Phosphatase* Aspartate Aminotransferase* Alanine Aminotransferase Former Test Name Hepatic Function Former Test Code [5318] Test Code See individual tests Page 11 of 34

12 December Monthly Update, See individual assays for changes Result Code Result Name Unit Of Measure LOINC Code Protein, Total g/dl Protein Albumin g/dl Albumin Globulin g/dl (calc) Globulin Albumin/Globulin Ratio Component Name calculation Albumin/Globulin Bilirubin, Total mg/dl Bilirubin Bilirubin, Direct mg/dl Bilirubin.glucuronidated+Bilirubin.albumin bound Bilirubin, Indirect mg/dl Bilirubin.non-glucuronidated Alkaline Phosphatase U/L Alkaline phosphatase AST U/L Aspartate aminotransferase ALT U/L Alanine aminotransferase Pricing Message Negotiated pricing on [5318] will be applied to code Infertility: Endocrine Evaluation (Female) Test Code [2016] Serum stored on barrier gel for more than 72 hours; plasma 5 days 7 days 28 days Result Name Age Gender Reference Range Unit Of Measure Prolactin Adult Male ng/ml Prolactin Adult Female (Non-pregnant) ng/ml Prolactin Adult Female (Pregnant) ng/ml Prolactin Adult Female (Postmenopausal) ng/ml Prolactin Tanner Stage I Male < or = 10.0 ng/ml ng/ml Prolactin Tanner Stage I Female ng/ml Prolactin Prolactin Prolactin Tanner Stage II-III Tanner Stage II-III Tanner Stage IV-V Male < or = 6.1 ng/ml Female ng/ml Male ng/ml Page 12 of 34

13 December Monthly Update, Prolactin No change to any other component Tanner Stage IV-V Female ng/ml Prolactin: Immunoassay No change to other components Lipid Panel Former Test Code [3454] Test Code 7600 Instructions Gross hemolysis; moderate to gross icterus; anticoagulants other than heparin If a Cholesterol or HDL Cholesterol measurement is to be performed along with Triglycerides, the patient should be fasting 9-12 hours prior to collection. The assay manufacturer Beckman Coulter advises: "N-Acetyl Cysteine (NAC), when administered in therapeutic concentrations (for the treatment of acetaminophen overdose), has been...determined to interfere with assays for...cholesterol, uric acid" where "NAC interference may lead to falsely low results." According to Beckman Coulter, the NAC interference should be insignificant by 12 hours after completion of the initial loading dose of an IV infusion treatment regimen consisting of an initial loading dose of 150 mg/kg administered over 1 hour, a second dose of 50 mg/kg administered over 4 hrs and a third dose of 100 mg/kg administered over 16 hrs. Result Code Result Name Unit Of Measure LOINC Code Component Name Cholesterol, Total mg/dl Cholesterol HDL Cholesterol mg/dl HDL Cholesterol Triglycerides mg/dl Triglyceride LDL Cholesterol mg/dl Cholesterol.in LDL Chol/HDLC Ratio calc Cholesterol.total/Cholesterol.in HDL Non HDL Cholesterol mg/dl Cholesterol.non HDL Pricing Message Negotiated pricing on [3454] will be applied to code Prolactin Former Test Code [3206] Test Code days 7 days 28 days Result Name Age Gender Unit Of Measure Prolactin Adult Male ng/ml Page 13 of 34

14 December Monthly Update, Prolactin Adult Female (Non-pregnant) ng/ml Prolactin Adult Female (Pregnant) ng/ml Prolactin Adult Female (Postmenopausal) ng/ml Prolactin Tanner Stage I Male < or = 10.0 ng/ml ng/ml Prolactin Tanner Stage I Female ng/ml Prolactin Tanner Stage II-III Male < or = 6.1 ng/ml Prolactin Tanner Stage II-III Female ng/ml Prolactin Tanner Stage IV-V Male ng/ml Prolactin Tanner Stage IV-V Female ng/ml Immunoassay Prolactin Prolactin Pricing Message Negotiated pricing on [3206] will be applied to code 746. Protein, Total, Serum Test Code 754 Gross hemolysis; plasma Protein, Total Protein, Total Protein Electrophoresis, with Total Protein and Reflex to IFE, Serum 747 Protein, Total and Protein Electrophoresis PSA (Prostate-Specific Antigen) with Serial Reporting Test Code Instructions [3546SR] Do not collect specimen after a transrectal biopsy, results may be falsely elevated. 7 days 14 days 28 days Page 14 of 34

15 December Monthly Update, Result Name Gender Unit Of Measure PSA, Total Male < or = 4.0 ng/ml PSA, Total Female Not established Males: < or = 4.0 ng/ml PSA, Total Former Test Code [3546] Test Code 5363 Instructions 1 ml (0.5 ml minimum) serum Do not collect specimen after a transrectal biopsy, results may be falsely elevated. 7 days 14 days 28 days Result Name Gender Unit Of Measure PSA, Total Male < or = 4.0 ng/ml PSA, Total Female Not established Males: < or = 4.0 ng/ml PSA, Total Prostate specific Ag Pricing Message Negotiated pricing on [3546] will be applied to code PSA, Free and Total Former Test Name PSA (Prostate-Specific Antigen), Free & Total Former Test Code [3547] Test Code Instructions 2 ml (0.6 ml minimum) frozen serum Do not collect specimen after a transrectal biopsy, results may be falsely elevated. Result Name Gender Unit Of Measure PSA, Total Male < or = 4.0 ng/ml Page 15 of 34

16 December Monthly Update, PSA, Total Female Not established Males: < or = 4.0 PSA, Free ng/ml ng/ml PSA, % Free Male >25 % (calc) PSA, % Free Female Not established Males: > 25 % (calc) Immunoassay PSA, Total Prostate specific Ag PSA, Free Prostate specific Ag.free PSA, % Free Prostate specific Ag.free/Prostate specific Ag.total Pricing Message Negotiated pricing on [3547] will be applied to code [P48873A] [RQT] Custom VA S. NV Total with Reflex Free PSA Reflex Prostate-Specific Antigen, Free PSA, Post Prostatectomy Former Test Code [S49587] Test Code Instructions Draw before rectal examination or biopsy procedure Result Name PSA, ICMA PSA, ICMA <0.10 ng/ml After radical prostatectomy < or = 4.0 ng/ml In healthy males without prostatectomy Quest Diagnostics Nichols Institute, San Juan Capistrano PSA, ICMA Prostate specific Ag Pricing Message Negotiated pricing on [S49587] will be applied to code PTH, Intact (ICMA) and Ionized Calcium Former Test Name PTH, Intact, including Ionized and Total Calcium Former Test Code [3944] Test Code Page 16 of 34

17 December Monthly Update, Result Name Age Unit Of Measure Parathyroid Hormone, Intact <6 years Not established Parathyroid Hormone, Intact 6-9 years 9-59 pg/ml Parathyroid Hormone, Intact years pg/ml Parathyroid Hormone, Intact years 9-69 pg/ml Parathyroid Hormone, Intact >17 years pg/ml Calcium Calcium, Ionized, Serum No change No change Result Code Result Name Unit Of Measure LOINC Code Component Name Parathyroid Hormone, Intact pg/ml Parathyrin.intact Calcium mg/dl Calcium Calcium, Ionized mg/dl Calcium.ionized Pricing Message Negotiated pricing on [3944] will be applied to code PTH, Intact (without Calcium) Former Test Code [3941] Test Code ml (1 ml minimum) serum Gross hemolysis; plasma; received room temperature; received refrigerated Result Name Age Unit Of Measure Parathyroid Hormone, Intact <6 years Not established Parathyroid Hormone, Intact 6-9 years 9-59 pg/ml Parathyroid Hormone, Intact years pg/ml Parathyroid Hormone, Intact years 9-69 pg/ml Parathyroid Hormone, Intact >17 years pg/ml Parathyroid Hormone, Intact Parathyrin.intact Pricing Message Negotiated pricing on [3941] will be applied to code PTH, Intact and Calcium Former Test Code [3943] Page 17 of 34

18 December Monthly Update, Test Code 8837 Gross hemolysis; grossly lipemic; grossly icteric; plasma; received room temperature; received refrigerated Result Name Age Unit Of Measure Parathyroid Hormone, Intact <6 years Not established Parathyroid Hormone, Intact 6-9 years 9-59 pg/ml Parathyroid Hormone, Intact years pg/ml Parathyroid Hormone, Intact years 9-69 pg/ml Parathyroid Hormone, Intact >17 years pg/ml Calcium No change Result Code Result Name Unit Of Measure LOINC Code Component Name Parathyroid Hormone, Intact pg/ml Parathyrin.intact Calcium mg/dl Calcium Pricing Message Negotiated pricing on [3943] will be applied to code Reflex PSA (Prostate-Specific Antigen, Free and Total) Test Code Instructions [RNQ] 2 ml (0.6 ml minimum) frozen serum Do not collect specimen after a transrectal biopsy, results may be falsely elevated. Result Name Gender Unit Of Measure PSA, Total Male < or = 4.0 ng/ml PSA, Total Female Not established Males: < or = 4.0 PSA, Free ng/ml ng/ml PSA, % Free Male >25 % (calc) PSA, % Free Female Not established Males: > 25 % (calc) Immunoassay Sex Hormone Binding Globulin Test Code ml (0.5 ml minimum) serum Page 18 of 34

19 December Monthly Update, and 14 days 60 days Thyroglobulin Panel Test Code ml (1 ml minimum) serum Result Name Thyroglobulin Antibodies Thyroglobulin < or = 1 IU/mL Intact Thyroid: ng/ml Athyrotic: <0.1 ng/ml Note: Abnormal flagging is based upon the reference interval for patients with intact thyroid [RNV] Reflex Thyroglobulin Autoantibodies [267] Thyroglobulin Antibodies [3060] Thyroid Antibodies Evaluation [1016] Thyroid Autoantibodies Quantitative Thyroglobulin without Thyroglobulin Antibodies Test Code Result Name Thyroglobulin Intact Thyroid: ng/ml Athyrotic: <0.1 ng/ml Note: Abnormal flagging is based upon the reference interval for patients with intact thyroid Immunoassay T4, Free Page 19 of 34

20 December Monthly Update, Former Test Code [3228] Test Code 866 Result Code Result Name Unit Of Measure LOINC Code Component Name T4, Free ng/dl Thyroxine.free Pricing Message Negotiated pricing on [3228] will be applied to code 866. Thyroid Cancer (Thyroglobulin) Monitoring Former Test Name Thyroid Cancer Monitoring Test Code Set-up/Analytic Time Set up: Mon-Fri; Report available: 8 days Result Name Thyroglobulin Antibody Thyroglobulin Thyroglobulin, LC/MS/MS < or = 1 IU/mL <0.1 ng/ml <0.4 ng/ml See individual assays Quest Diagnostics Nichols Institute, San Juan Capistrano Thyroglobulin Antibody Thyroglobulin Ab *TR Non-orderable Thyroglobulin Thyroglobulin Thyroglobulin *TR Non-orderable Thyroglobulin, LC/MS/MS Thyroglobulin, LC/MS/MS Thyroglobulin *TR (True Reflexing Flag) Interfaced clients: If you are set up to use our True Reflexing option, build the unit code with the TR flag (indicated above) separately. Additional Information If Thyroglobulin Antibody is negative, then Thyroglobulin is tested on the Beckman Coulter DxI (CPT code: 84432). If Thyroglobulin Antibody is positive then, Thyroglobulin is tested by LC/MS/MS (CPT code: 84432). TSH Test Code 899 Preferred: 1 ml (0.7 ml minimum) serum Page 20 of 34

21 December Monthly Update, Acceptable: Plasma collected in a sodium heparin (green-top) tube is no longer acceptable Plasma Chronic Urticaria Panel 2 (Comprehensive) [3060] Thyroid Antibodies Evaluation [3072] Thyroid Panel Hyperthyroidism Male [3074] Thyroid Panel, Hypothyroidism with TSH [3250SR] Thyroid Stimulating Hormone with Serial Reporting [1090] Thyrotropin Receptor Autoantibodies with TSH Chromosomal Microarray, Prenatal, ClariSure Oligo-SNP Message **This test is now available for New York patient testing.** Effective Date 1/18/2016 Test Code Quest Diagnostics Nichols Institute, San Juan Capistrano Result Code Type Result Name LOINC Code Component Name ClariSureOligoSNP,Prenatl Pending Assignment Prompt-Result (no return) Prompt-Result (no return) Prompt-Result (no return) Prompt-Result (no return) Prompt-Result (no return) Prompt-Result (no return) Prompt-Result (no return) Specimen Type/Source/Vol: Clinical Indication: Clinical information Referring Physician: Primary referring physician ID Referring Physician Phone: Client/Phone #: Client Accession #: Attending physician phone number Patient ID: Internal identifier C-Reactive Protein (CRP) Effective Date 1/18/2016 Former Test Code [1535] Test Code 4420 Result Code Result Name Unit Of Measure LOINC Code Component Name Page 21 of 34

22 December Monthly Update, C-Reactive Protein mg/dl C reactive protein Pricing Message Negotiated pricing on [1535] will be applied to code Cyclic Citrullinated Peptide (CCP) Antibody (IgG) Effective Date 1/18/2016 Former Test Code [3133] Test Code Gross hemolysis; grossly lipemic; plasma 4 days 7 days 30 days Result Code Result Name Unit Of Measure LOINC Code Component Name CCP Antibody (IgG) U Cyclic citrullinated peptide Ab.IgG Pricing Message Negotiated pricing on [3133] will be applied to code [1013] Rheumatoid Arthritis EvaluatR Hepatitis A Antibody, Total Effective Date 1/18/2016 Former Test Code [2450] Test Code 508 Preferred: 1 ml (0.5 ml minimum) serum Acceptable: Plasma collected in EDTA (lavender-top) tube Heparinized plasma is no longer acceptable and 14 days 30 days Hepatitis A Ab, Total Hepatitis A virus Ab Page 22 of 34

23 December Monthly Update, Pricing Message Negotiated pricing on [2450] will be applied to code 508. [2463] Hepatitis A & B Evaluation [2460] Hepatitis A Virus Total and IgM Antibodies [2464] Hepatitis A, B, & C Virus Evaluation Hepatitis A Antibody, Total with Reflex to IgM Effective Date 1/18/2016 Former Test Code [2477] Test Code ml (0.5 ml minimum) serum Gross hemolysis; grossly lipemic; plasma collected in a PPT potassium EDTA (white-top) tube Immunoassay Hepatitis A Ab, Total Hepatitis A virus Ab This is a true reflex. Please build the unit code below separately. Non-orderable Reflex: RFJ - Reflex Hepatitis A Antibody, IgM Hepatitis A Ab IgM Hepatitis A virus Ab.IgM Pricing Message Negotiated pricing on [2477] will be applied to code [7758] Hepatitis A, B & C Post B Exposure Panel hs-crp Effective Date 1/18/2016 Test Code Preferred: 1 ml (0.5 ml minimum) serum Acceptable: Plasma collected in sodium heparin (green-top), lithium heparin (green-top), EDTA (lavender-top) or EDTA (royal blue-top) tube Gross hemolysis; grossly lipemic and 7 days 90 days Page 23 of 34

24 December Monthly Update, [1537] Treatable Ischemia PredictR IgA Effective Date 1/18/2016 Former Test Code [1506] Test Code 539 Grossly lipemic 72 hours 7 days 90 days Result Code Result Name Unit Of Measure LOINC Code Component Name Immunoglobulin A mg/dl IgA Pricing Message Negotiated pricing on [1506] will be applied to code Celiac Disease Comprehensive Panel Celiac Disease Comprehensive Panel, Infant Immunoglobulins Panel, Serum Effective Date 1/18/2016 Test Code 7083 Gross hemolysis; grossly lipemic Immunoturbidimetric Result Code Result Name Unit Of Measure LOINC Code Component Name Immunoglobulin A mg/dl IgA Immunoglobulin G mg/dl IgG Immunoglobulin M mg/dl IgM 543 VAL [1505] - Immunoglobulin G and 545 VAL [1508] - Immunoglobulin M result names will be updated and the codes are listed as tests affected. Please note that these are contained in other group codes. Page 24 of 34

25 December Monthly Update, [P38164B] [P35691K] [P48006B] [P432780] [P6152A] [P41643A] [P41835B] [P36116A] Custom Carson Myeloma Panel Custom CCRMC Mono Gammopathies and Immunoglobulins Custom Crisp Immunoelectrophoresis Panel Custom Duncan Myeloma Panel Custom Fremont Rideout Immunoelectrophoresis Serum Custom Houston PEP/IFE Panel Custom PPL Immunofixation electrophoresis with Monoclonal and Quant Custom Tulare District Hospital Immunofixation Panel [1505] Immunoglobulin G [1506] Immunoglobulin M Lyme Disease Antibodies (IgG, IgM), Immunoblot Effective Date 1/18/2016 Test Code 8593 Gross hemolysis; grossly lipemic Immunoblot Lyme Disease Antibody (IgG), Immunoblot [7714BNY] Lyme Disease Antibody (IgM) Immunoblot Lyme Disease Antibody with Reflex to Blot (IgG, IgM) Effective Date 1/18/2016 Test Code 6646 Additional Information If Lyme Antibody Screen is Equivocal or Positive, then Lyme Disease Antibodies (IgG, IgM) by Immunoblot will be performed at an additional charge (CPT codes: (x2)). Mumps Virus Antibody (IgG) Effective Date 1/18/2016 Former Test Name Mumps IgG Antibodies Former Test Code [9716] Test Code 8624 Preferred: 1 ml (0.1 ml minimum) serum Page 25 of 34

26 December Monthly Update, Acceptable: Plasma is no longer acceptable Gross hemolysis; grossly lipemic 4 days 7 days 30 days Mumps Virus Antibody (IgG) Mumps virus Ab.IgG Pricing Message Negotiated pricing on [9716] will be applied to code [1341] Immune Staus Panel - MMR Rheumatoid Arthritis Diagnostic Panel IdentRA(TM) with eta Effective Date 1/18/2016 Test Code Quest Diagnostics Nichols Institute, San Juan Capistrano Result Code Result Name Unit Of Measure LOINC Code Component Name 778 Rheumatoid Factor IU/mL Rheumatoid factor CCP Antibody (IgG) U Cyclic citrullinated peptide Ab.IgG eta Protein ng/ml eta protein Bacterial Vaginosis/Vaginitis Panel Message Includes: Candida species*trichomonas vaginalis*gardnerella vaginalis Effective Date 1/25/2016 Test Code Vaginal swab (One BD AFFIRM ATTS swab minimum) from the posterior fornix and the vaginal wall. Place swab immediately in the AFFIRM VPIII Ambient Temperature Transport System (ATTS). Specimen >72 hours old; swabs received in transport systems other than AFFIRM VPIII Ambient Temperature Transport System (ATTS); received frozen Quest Diagnostics Nichols Institute, Chantilly Chlamydia trachomatis RNA, TMA Effective Date 1/25/2016 Test Code Page 26 of 34

27 December Monthly Update, Preferred: 1 ml liquid cytology (PreservCyt ) preservative (ThinPrep ) collected in APTIMA specimen transfer tube (green label) or APTIMA Vaginal Collection Kit (orange label) or APTIMA Unisex Swab Specimen Collection Kit. Endocervical or urethral swabs in APTIMA Combo 2 Assay Unisex Swab Specimen Collection Kit. Vaginal swabs in the APTIMA Combo 2 Assay Vaginal Swab Collection Kit. Acceptable: Urine (no preservatives): 2 ml of urine, specimen must be transferred into the APTIMA Urine Transport Medium within 24 hours of collection and before being assayed, ThinPrep vial, SurePath vial or 0.5 ml of SurePath preservative fluid collected in APTIMA specimen transfer tube (green label) or APTIMA Vaginal Collection Kit (orange label). Instructions Labs performing cytology: Aliquot PreservCyt or SurePath solution before performance of liquidbased cytology testing. PreservCyt : Transfer 1 ml to PreservCyt solution into APTIMA specimen transfer tube (green label) or APTIMA vaginal collection tube (orange label). Ship to lab. Endocervical or urethral swabs: Follow instructions in the APTIMA Combo 2 Assay Unisex Swab Specimen Collection Kit. In females, to insure collection of cells infected with C. trachomatis, columnar epithelial cells lining the endocervix should be obtained. To that effect, excess mucus should be removed prior to sampling. Vaginal swabs: Follow instructions in the APTIMA Combo 2 Assay Vaginal Swab Collection Kit. Urine: Patient should not have urinated within one hour prior to collection. Female patients should not cleanse the labial area prior to providing the specimen. Direct patient to provide a first-catch urine (a maximum of ml of the initial urine stream) into a urine collection cup free of any preservatives. 2 ml of urine specimen must be transferred into the APTIMA specimen transport within 24 hours of collection and before being assayed. Use tube provided in the urine specimen collection kit for urine specimens. The fluid (urine plus transport media) level in the urine tube must fall within the clear pane on the tube label. Liquid cytology (PreservCyt ) preservative (ThinPrep ) 14 days Liquid cytology (PreservCyt ) preservative (ThinPrep ) 30 days Liquid cytology (PreservCyt ) preservative (ThinPrep ) Not established SurePath preservative fluid and 14 days SurePath preservative fluid Not established Urine in APTIMA transport medium and 30 days Urine in APTIMA transport medium 1 year Cervical/vaginal swabs in APTIMA transport and 60 days Cervical/vaginal swabs in APTIMA transport 1 year Urethral swabs in APTIMA transport: and 60 days Urethral swabs in APTIMA transport: 6 months Neisseria gonorrhoeae RNA, TMA Effective Date 1/25/2016 Page 27 of 34

28 December Monthly Update, Test Code Preferred: 1 ml liquid cytology (PreservCyt ) preservative (ThinPrep ) collected in APTIMA specimen transfer tube (green label) or APTIMA Vaginal Collection Kit (orange label) or APTIMA Unisex Swab Specimen Collection Kit. Endocervical or urethral swabs in APTIMA Combo 2 Assay Unisex Swab Specimen Collection Kit. Vaginal swabs in the APTIMA Combo 2 Assay Unisex Swab Specimen Collection Kit. Acceptable: Urine (no preservatives): 2 ml of urine, specimen must be transferred into the APTIMA Urine Transport Medium within 24 hours of collection and before being assayed, ThinPrep vial, SurePath vial or 0.5 ml of SurePath preservative fluid collected in APTIMA specimen transfer tube (green label) or APTIMA Vaginal Collection Kit (orange label). Chlamydia/Neisseria gonorrhoeae RNA,TMA Effective Date 1/25/2016 Test Code Preferred: 1 ml liquid cytology (PreservCyt ) preservative (ThinPrep ) collected in APTIMA specimen transfer tube (green label) or APTIMA Vaginal Collection Kit (orange label) or APTIMA Unisex Swab Specimen Collection Kit. Endocervical or urethral swabs in APTIMA Combo 2 Assay Unisex Swab Specimen Collection Kit. Vaginal swabs in the APTIMA Combo 2 Assay Vaginal Swab Collection Kit. Acceptable: Urine (no preservatives): 2 ml of urine, specimen must be transferred into the APTIMA Urine Transport Medium within 24 hours of collection and before being assayed, ThinPrep vial, SurePath vial or 0.5 ml of SurePath preservative fluid collected in APTIMA specimen transfer tube (green label) or APTIMA Vaginal Collection Kit (orange label). [A11363C] ALT-SureSwab, C. trachomatis/n. gonnorhoeae, TMA SureSwab(R), CT/NG, T vaginalis SureSwab(R), Vaginosis, Chlamydia trachomatis/neisseria gonorrhoeae SureSwab, Vaginosis/Vaginitis Plus Effective Date 1/25/2016 Test Code Non-APTIMA Vaginal Swab Collection Kit; male samples See Laboratory Report Dual Kinetic Assay; Real-Time Polymerase Chain Reaction; Target Capture; Transcription-Mediated Amplification SureSwab, Bacterial Vaginosis DNA, Quantitative PCR Page 28 of 34

29 December Monthly Update, SureSwab, Bacterial Vaginosis/Vaginitis SureSwab, Vaginosis, CT/NG Hepatitis B Virus DNA, Quantitative, Real-Time PCR Effective Date 1/25/2016 Test Code 8369 Instructions 3 ml (1 ml minimum) plasma collected and separated from an EDTA (lavender-top) tube Unspun whole blood samples greater than 24 hours from collection Plasma: Separate plasma from whole blood (EDTA tube) within 24 hours from the time of collection. Serum: Separate serum from a serum separator tube within 24 hours from the time of collection. Note: This test requires a separately collected sample. [2479] Hepatitis B MonitR, Chronic [2479] Hepatitis B Virus MonitR, Chronic Hepatitis C Viral RNA, Genotype, LiPA Effective Date 1/25/2016 Test Code Result Name HCV Genotype, LiPA(R) See Laboratory Report Multi-Probe Reverse Hybridization Focus Diagnostics, Inc. Hepatitis C Viral RNA, Quantitative, Real-Time PCR Effective Date 1/25/2016 Test Code Instructions 3 ml (1 ml minimum) plasma collected and separated from an EDTA (lavender-top) tube Whole blood samples greater than 24 hours old; frozen whole blood Freshly drawn specimens (whole blood) may be stored at 2 C to 25 C for up to 24 hours prior to centrifugation. Separate plasma or serum from cells within 24 hours of collection by centrifugation. Follow manufacturer s instructions for collection tube handling Hepatitis C Antibody with Reflex to HCV RNA, QN RT-PCR Hepatitis C-Infected Patient, Treatment Panel Page 29 of 34

30 December Monthly Update, HIV-1 RNA, Quantitative PCR with Reflex to Genotype Effective Date 1/25/2016 Test Code ml (2 ml minimum) plasma collected in an EDTA (lavender-top) tube Plasma received frozen in the plasma preparation tube (PPT); serum; whole blood greater than 24 hours old; frozen whole blood Real-Time Polymerase Chain Reaction Focus Diagnostics, Inc. HIV-1 RNA, Quantitative, Real-Time PCR Effective Date 1/25/2016 Test Code Instructions 3 ml (1 ml minimum) plasma collected in an EDTA (lavender-top) or PPT (white-top) tube Plasma received frozen in the plasma preparation tube (PPT); serum; whole blood greater than 24 hours old; frozen whole blood Freshly drawn specimens (whole blood) may be stored at 2 C to 25 C for up to 24 hours prior to centrifugation. Separate plasma from cells within 24 hours of collection by centrifugation. Follow manufacturer s instructions for collection tube handling. [P5475H] [7485ASR] CUS FCH HIV-1 RNA QNT RT PCR HIV-1 RNA Quantitation [Real-Time PCR with Serial Reporting HPV DNA, High Risk Effective Date 1/25/2016 Former Test Code [1821] Test Code Preferred: Digene specimen transport medium containing Digene DNA collection device/brush/cervical sampler or ThinPrep PreservCyt Solution. Acceptable: Cervical biopsy 2-5 mm in cross section placed immediately into Digene specimen transport medium and frozen at -20 or SurePath vial if cytology is also requested, or SurePath CytoRich fraction if cytology is not requested Minimum: Digene specimen transport medium: 1 ml ThinPrep PreservCyt solution: 4.1 ml SurePath CytoRich fraction: 2 ml pellet re-suspended Swabs; ThinPrep PreservCyt if received frozen; SurePath CytoRich fraction if received frozen : Cervical brush or broom in Digene specimen, Cytyc PreservCyt - ThinPrep and SurePath CytoRich Fraction : Cervical biopsy Page 30 of 34

31 December Monthly Update, SurePath CytoRich Fraction (pellet) 14 days from date of collection SurePath CytoRich Fraction (pellet) 14 days SurePath CytoRich Fraction (pellet) Unacceptable Digene specimen 14 days Digene specimen 21 days Digene specimen 90 days ThinPrep PreservCyt : and 90 days ThinPrep PreservCyt : Unacceptable No change to other sample types Hybrid Capture II Result Code Result Name HPV DNA (High Risk) LOINC Code Component Name Human papilloma virus DNA Pricing Message Negotiated pricing on [1821] will be applied to code [1822R] HPV DNA High and Low Risk, Anal-Rectal 1822 HPV DNA, High and Low HPV High Risk, Hybrid Capture II Rfl Genotypes 16, 18 HPV Genotypes 16, 18/45 Effective Date 1/25/2016 Test Code CPT Codes Preferred: 1 ml Liquid Cytology (PreservCyt ) Preservative (ThinPrep ) Acceptable: ThinPrep vial APTIMA Unisex Swab Specimen Collection Kit (white label) for vaginal specimens are no longer acceptable Focus Diagnostics, Inc. HPV mrna E6/E7 Effective Date 1/25/2016 Test Code Page 31 of 34

32 December Monthly Update, Instructions For clients performing their own cytology (pap testing), who choose to send HPV mrna testing to Quest Diagnostics, the preferred specimen requirement steps should be adhered to. 30 days 90 days Unacceptable Methylmalonic Acid Effective Date 1/25/2016 Former Test Code [3496] Test Code days 7 days 10 months Set-up/Analytic Time Set up: Daily; Report available: 5-6 days Result Name Unit Of Measure Methylmalonic Acid nmol/l Mass Spectrometry This test previously performed at will now be performed at Quest Diagnostics Nichols Institute, San Juan Capistrano Result Code Result Name Unit Of Measure LOINC Code Component Name Methylmalonic Acid nmol/l Methylmalonate Pricing Message Negotiated pricing on [3496] will be applied to code Methylmalonic Acid and Homocysteine Redirects Cervical Cancer, TERC, FISH Effective Date 1/18/2016 Test Code Set-up/Analytic Time Set up: Mon-Sat; Report available: 1-3 days Page 32 of 34

33 December Monthly Update, This test previously performed at Quest Diagnostics Nichols Institute, Chantilly will now be performed at Quest Diagnostics Nichols Institute, San Juan Capistrano Reporting Title: CERVICAL CANCER,TERC,FISH Result Code Type Result Name LOINC Code Cervical Cancer,TERC,FISH Prompt-Result (no return) Prompt-Result (no return) Prompt-Result (no return) Prompt-Result (no return) Prompt-Result (no return) Prompt-Result (no return) Prompt-Result (no return) Prompt-Result (no return) Prompt-Result (no return) Specimen Type/Source/Vol: Component Name Pending assignment Clinical Indication: Clinical information LSIL/HSIL on prev PAP/Bx Hx on HPV Human papilloma virus immunization status Client Accession #: Patient ID: Internal identifier Referring Physician: Primary referring physician ID Referring Physician Phone: Client/Phone #: Attending physician phone number Discontinued Tests Sex Hormone Binding Globulin (SHBG) Test Code [3218] Additional Information Please use test code Sex Hormone Binding Globulin Pricing Message Negotiated pricing on [3218] will be applied to code Bisphenol A and Creatinine, Random Urine Effective Date 1/18/2016 Test Code Additional Information Pricing Message The recommended alternative is test code Bisphenol A-Total (Conjugated/Unconjugated), Urine Due to the suggested replacement negotiated fees will not be copied. Hepatitis B Virus DNA, Quantitative, Real-Time PCR Effective Date 1/25/2016 Test Code 8137 Additional Information Please use test code Hepatitis B Virus DNA, Quantitative, Real-Time PCR Pricing Message Negotiated pricing on [8137] will be applied to code 8369 Page 33 of 34

34 December Monthly Update, HIV-1 RNA, Quantitative, Real-Time PCR Effective Date 1/25/2016 Test Code Additional Information 7485A Please use test code HIV-1 RNA, Quantitative, Real-Time PCR. Pricing Message Negotiated pricing on [7485A] will be applied to code Test Send Outs (Referrals) Bisphenol A-Total (Conjugated/Unconjugated), Urine Effective Date 1/18/2016 Test Code CPT Codes Instructions 3 ml (1.2 ml minimum) urine submitted in a polypropylene container Received room temperature; received refrigerated; polycarbonate plastic container Avoid use of polycarbonate plastics when collecting samples Not stable 48 hours 30 days Set-up/Analytic Time Set up: Wed; Report available: 4 days Result Name Unit Of Measure Bisphenol A, Total None Detected ng/ml Gas Chromatography/Mass Spectrometry Result Code Result Name Unit Of Measure Bisphenol A,- Total ng/ml Page 34 of 34 Quest, Quest Diagnostics, the associated logo, Nichols Institute and all associated Quest Diagnostics marks are the trademarks of Quest Diagnostics Quest Diagnostics Incorporated. All rights reserved.

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