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Mitochondrial M2 Antibody, IgG (ELISA) Ordering Recommendation May be useful in confirming a diagnosis of primary biliary cholangitis. Mnemonic AMA Performed Mon-Sat Methodology Semi-Quantitative Enzyme-Linked Immunosorbent Assay Reported Within 24 hours New York DOH Approval Status This test is New York DOH approved. Specimen Required Patient Preparation: Collect: Serum separator tube. Specimen Preparation: Separate serum from cells ASAP or within 2 hours of collection. Transfer 0.5 mL to a Standard Transport Tube. (Min: 0.3 mL) Storage/Transport Temperature: Refrigerated. Unacceptable Conditions: Plasma. Contaminated, hemolyzed, grossly icteric, or severely lipemic specimens. Remarks: Stability: After separation from cells: Ambient: 48 hours; Refrigerated: 2 weeks; Frozen: 1 year (avoid repeated freeze/thaw cycles) Reference Interval 20.0 Units or less Negative 20.1-24.9 Units 25.0 Units or greater Equivocal Positive Interpretive Data Anti-mitochondrial antibodies (AMA) are thought to be present in 90-95% of patients with primary biliary cholangitis (PBC). However, the frequency of detected antibodies may be cohort or assay dependent, as lower sensitivities have been reported. Not all PBC patients are positive for AMA; some patients may be positive for SP100 and/or GP210 antibodies. A negative result does not rule out PBC. Compliance Category: FDA Note CPT Code 86381 Components Component Chart Name Mitochondrial (M2) Antibody, IgG Component Test Code 0050065 LOINC 14251-3 Aliases AMA ANTI-MITOCHONDIRAL ANTIBODY ANTIBODIES TO MICROTUBULE ASSOCIATED PROTEIN 2 ANTIMITOCHONDRIAL ANTIBODIES IMMUNOLOGY PROFILE (AMA) MITOCHONDRIAL ANTIBODIES, SERUM

Myeloperoxidase (MPO) Antibody Ordering Recommendation When used in conjunction with other autoantibody tests (ANCA, PR3), may aid in evaluating suspected immune-mediated vasculitis, especially microscopic polyangiitis (MPA). May be useful to monitor MPA disease and/or treatment response. ​ Panel tests are available. For the workup of suspected vasculitis, refer to ANCA-Associated Vasculitis Profile (ANCA/MPO/PR3) (3003745 ). For patients with a history of vasculitis, refer to Myeloperoxidase (MPO) Antibody and Serine Proteinase 3 (PR3) Antibody with Reflex to Anti-Neutrophil Cytoplasmic Antibody, IgG by IFA (3003746 ). ​ ​ Mnemonic MPO-AB Performed Mon-Sat Methodology Semi-Quantitative Multiplex Bead Assay Reported 1-3 Days New York DOH Approval Status This test is New York DOH approved. Specimen Required Patient Preparation: Collect: Serum separator tube. Specimen Preparation: Separate serum from cells ASAP or within 2 hours of collection. Transfer 1 mL serum to a Standard Transport Tube. (Min: 0.2 mL) Storage/Transport Temperature: Refrigerated. Unacceptable Conditions: Plasma, urine, or other body fluids. Contaminated, hemolyzed, or severely lipemic specimens., icteric, or lipemic specimens. Remarks: Stability: After separation from cells: Ambient: 48 hours; Refrigerated: 2 weeks; Frozen: 1 year (avoid repeated freeze/thaw cycles) Reference Interval 19 AU/mL or less Negative 20-25 AU/mL 26 AU/mL or greater Equivocal Positive Interpretive Data Approximately 90% of patients with a P-ANCA pattern by IFA have antibodies specific for MPO. Compliance Category: FDA Note CPT Code 83516 Components Component Chart Name Myeloperoxidase (MPO) Ab, IgG Component Test Code 0050526 LOINC 6969-0 Aliases MPO MPO Ab PR3

Cardiolipin Antibody, IgM Ordering Recommendation Acceptable initial test when antiphospholipid syndrome (APS) is highly suspected. Order with Lupus Anticoagulant Reflexive Panel (0030181 ) and Beta-2 Glycoprotein 1 Antibodies, IgG and IgM (0050321 ). Cardiolipin Antibodies, IgG and IgM (0099344 ) is preferred. Mnemonic AC-IGM Performed Mon-Sat Methodology Semi-Quantitative Enzyme-Linked Immunosorbent Assay Reported 1-2 days New York DOH Approval Status This test is New York DOH approved. Specimen Required Patient Preparation: Collect: Serum separator tube. Specimen Preparation: Separate serum from cells ASAP or within 2 hours of collection. Transfer 1 mL serum to a Standard Transport Tube. (Min: 0.3 mL) Storage/Transport Temperature: Refrigerated. Unacceptable Conditions: Plasma or other body fluids. Contaminated, heat-inactivated, hemolyzed, or lipemic specimens. Remarks: Stability: After separation from cells: Ambient: 48 hours; Refrigerated: 2 weeks; Frozen: 1 year Reference Interval <=12 MPL Negative 13-19 MPL Indeterminate 20-80 MPL Low to Moderately Positive 81 MPL or above High Positive Interpretive Data The persistent presence of IgG and/or IgM cardiolipin (CL) antibodies in moderate or high levels (greater than 40 GPL and/or greater than 40 MPL units) is a laboratory criterion for the diagnosis of antiphospholipid syndrome (APS). Persistence is defined as moderate or high levels of IgG and/or IgM CL antibodies detected in two or more specimens drawn at least 12 weeks apart (J Throm Haemost. 2006;4:295-306). Lower positive levels of IgG and/or IgM CL antibodies (above cutoff but less than 40 GPL and/or less than 40 MPL units) may occur in patients with the clinical symptoms of APS; therefore, the actual significance of these levels is undefined. Results should not be used alone for diagnosis and must be interpreted in light of APS-specific clinical manifestations and/or other criteria phospholipid antibody tests. Compliance Category: FDA Note MPL = IgM phospholipid units CPT Code 86147 Components Component Chart Name Cardiolipin Antibody IgM Component Test Code 0050902 LOINC 3182-3 Aliases ACA aCL aCL Antibody aCL IgG Anti-Cardiolipin Anticardiolipin Anticardiolipin Antibodies Cardiolip

What to Expect Clinical Diagnostics Laboratories (CDL) will make your specimen collection process safe, quick, and as comfortable as possible. We will also make sure to safeguard your privacy and will be treated with the utmost care and dignity. ​ While walk-ins to our lab are welcome during the week, we highly recommend scheduling an appointment if you are pressed for time or if you will require blood work. Weekends are by appointment only. When Visiting the Lab You Should Bring the Following: If you are paying out of pocket fo r a lab, then a lab request is not necessary to have from your doctor but if you are planning on submitting it to your insurance please bring the lab request from your doctor's office, or ask your doctor to email to us prior to your appointment. ✔️ A current insurance identification car d, (Medicare, Private Insurance, or HMO/PPO) ✔️A photo Id (Drivers License or employee identification badge) ✔️A health spending card, personal check, cash, or mobile PayPal account. ​ ​ ​ ​ ​ ​ Our Process as a Patient at O ur Facility: ​ ​ View Accepted Insurance 01 Schedule An Appointment 02 On the date and time of your appointment, we'll take your doctor's order and make a copy of your ID and Insurance. We'll also have you sign a consent form during this time 03 Once your information is copied, the proper items for your test will be prepared. This typically takes about 5-10 minutes depending on the test being performed. 04 Meet with the nurse for your test. This process typically takes around 5-10 minutes. 05 Once you finish your test, your results will be delivered to your doctor if you provided an order. If you did not provide an order, the results will be sent as a PDF file to your email address. Results typically take 3-10 days depending on the test perfofrmed. For more information on how long your test might take, please conact us. Schedule An Appointment

Services for Government Agencies Clinical Diagnostics Laboratories does not currently work with any government agencies but we are registered in the same database and are a female-owned and operated, minority company. Clinical Diagnostics Laboratories is always available and open for opportunities. If you're interested in learning more about our services or are interested in working with us, please contact us for more information. CONTACT US

PARTICIPATING INSURANCE COMPANIES Clinical Diagnostics Laboratories will file all claims with the below-listed insurance companies. The list below is not a complete list of Health plans with which CDL participates and is subject to change over time. There may be exceptions in certain areas or for certain members or plans. If you have any questions or do not see your insurance company listed here, please contact us. AARP Adventist HealthCare Aetna (PPO) American Postal Workers Union (APWU) AmeriGroup Health AmeriHealth Anthem Assurant Health Beechstreet Benefit Plan Administrators VA Blue Cross Blue Shield of VA PPO, KeyCare, Cova, Medicare Advantage PPO Anthem Blue Cross (PPO, Medicare PPO)Blue Cross Blue Shield of West VA BRMS Capital Blue Cross (PPO Only) Care Improvement Plus-United Health CareFirst BCBS CareLink CareNet Celtic Insurance ChoiceCare Cigna (Multiplan) Cofinity Compass Rose Conifer Health Solution CoreSource Corvel Coventry National PPO Emblem Health (PPO Only) Empire BCBS (PPO Only) Federal and State Benefit Health Plans FEHBP FedMed Inc First Health National PPO Network Fortis Insurance -Assurant Galaxy Health Network GEHA-(First Health) Geisinger Health Great West HealthAmerica HealthPartners Network HealthScope Services HealthSmart Preferred Networks Highmark BCBS (PPO Only) Horizon BCBS (PPO Only) Humana (All Plans) InterPlan Health Group-HealthSmart John Alden Insurance -Assurant Johns Hopkins Healthcare MagnaCare Mail Handlers Benefit Plan Maryland Physicians Care (MPC) MedCost (NovaNet) Medical Mutual Meritain Health Multiplan National Network NALC- Cigna, Multiplan National Capital PPO, Health Link National Care Network NCN National Claims Administrative Services (NCAS) NovaNet PPO OneNet PPO (United Health Care) Optima Health Network-Valley Health Net Paramount Health Care PayerFusion POMCO Prime Health Services Private Healthcare (PMCS) Pyramid Life Insurance Company Riverside Health(Maryland HealthChoice) Ryan White HIV/Aids Program ​ SAMBA FEP StarMark Insurance Stratrose PPO, NPPN SummaCare PPO (Multiplan, PHCS) SuperMed PPO-1st Medical The Health Plan Three Rivers Provider Network Unicare UnitedHealthcare Virginia Health Network-MedCost Ultra, VHN Plus USA MCO Government Health Plans Medicaid VA, MD, and DC Medicare Advantage PPO Medicare Supplement Railroad Medicare Traditional Medicare Tricare Health Net Federal Services Humana Military TriCare for Life TriWest SCHEDULE AN APPOINTMENT Last Name Email Phone Type your message here... Submit Thanks for submitting! A member of our team will respond to your inquiry as soon as possible.

Double-Stranded DNA (DsDNA) Antibody Ordering Recommendation Secondary screening for systemic lupus erythematosus (SLE) based on ANA results. Mnemonic Methodology Semi-Quantitative Enzyme-Linked Immunosorbent Assay/Semi-Quantitative Indirect Fluorescent Antibody Performed Mon-Sat Reported 1-3 Days New York DOH Approval Status This test is New York DOH approved. Specimen Required Patient Preparation: Collect: Serum separator tube (SST). Specimen Preparation: Separate serum from cells ASAP or within 2 hours of collection. Transfer 1 mL serum to a Standard Transport Tube. (Min: 0.5 mL) Storage/Transport Temperature: Refrigerated Unacceptable Conditions: Plasma. Contaminated, hemolyzed, or severely lipemic specimens. Remarks: Stability: After separation from cells: Ambient: 48 hours; Refrigerated: 2 weeks; Frozen: 1 month (avoid repeated freeze/thaw cycles) Reference Interval 24 IUs or less Double-Stranded DNA (dsDNA) Ab IgG ELISA Interpretive Data Positivity for anti-double stranded DNA (anti-dsDNA) IgG antibody is a diagnostic criterion of systemic lupus erythematosus (SLE). Specimens are initially screened by enzyme-linked immunosorbent assay (ELISA). If ordered as reflex (0050215), positive ELISA results (>24 IU) will be reflexed to a highly specific IFA titer (Crithidia luciliae indirect fluorescent test [CLIFT]) for confirmation. Some patients with early or inactive SLE may be positive for anti-dsDNA IgG by ELISA but negative by CLIFT. If the patient is negative by CLIFT but positive by ELISA and clinical suspicion remains, consider antinuclear antibody (ANA) testing by IFA. Note If dsDNA IgG antibody is detected, the result will be confirmed by Double-Stranded DNA (dsDNA) Antibody, IgG by IFA (using Crithidia luciliae). Additional charges apply. CPT Code 86225; if reflexed, add 86256 Components Component Chart Name Component Test Code LOINC Double-Stranded DNA (dsDNA) Ab IgG ELISA 0050215 58465-6 Aliases anti-DNA Anti-dsDNA Antibody Anti-Native DNA Antibody to ds-DNA Crithidia luciliae DNA ds Ab Double stranded DNA antibody ds DNA Ab ds-DNA ds-DNA IgG dsDNA reflex dsDNA reflex panel Native double-stranded DNA antibody

Privacy Statement 1. Introduction Welcome to Clinical Diagnostic Laboratories ("we," "us," or "our"). This Privacy Statement outlines how we collect, use, disclose, and safeguard your personal and medical information when you use our services, including our website and related applications (collectively referred to as the "Services"). By using our Services, you consent to the practices described in this Privacy Statement. 2. Information We Collect We may collect various types o f information from you, including: Personal Information: Name, contact information, date of birth, and other relevant identifiers. Medical Information: Information related to your health, medical history, and test results. Payment Information: Payment details for services purchased through our platform. Usage Data: Information about how you use our Services, including website interactions and app usage. 3. How We Use You r Infor mation We use the collected information for the following purposes: Providing Services: To deliver and manage the diagnostic testing services you request, including appointment scheduling and test result delivery. Communication: To contact you regarding appointments, test results, billing, and other relevant matters. Improving Services: To enhance and customize your experience with our Services, and to develop new features and offerings. Legal and Regulatory Compliance: To comply with applicable laws, regulations, and legal processes. 4. Information Sharing We may share your information with: Healthcare Providers: To facilitate the interpretation and communication of test results by qualified medical professionals. Service Providers: Third-party vendors and partners who assist us in providing and maintaining our Services. Legal Authorities: When req uired by law or in response to legal requests, such as court orders or subpoenas. 5. Data Security We implement appropriate technical and organizational measures to safeguard your personal and medical information. However, no data transmission over the Internet is completely secure, and we cannot guarantee the absolute security of your information. 6. Your Choices Access and Correction: You may review, update, or correct your personal information by contacting us. Communications: You can choose to receive or opt out of certain communications from us. Cookies and Tracking: You can manage your cookie preferences through your browser settings. 7. Third-Party Links Our Services may contain links to third-party websites. We are not responsible for the privacy practices or content of these websites. Please review the privacy policies of third-party sites before providing any personal information. 8. Children's Privacy Our Services are not intended for individuals un der the age of 18. We do not knowingly collect personal information from children. 9. Changes to this Privacy Statement We may update this Privacy Statement to reflect changes in our practices or legal requirements. Any changes will be posted on our website, and the date of the latest revision will be indicated. 10. Contact Us If you have questions, concerns, or requests related to your privacy or this Privacy Statement, please contact us at: ​ Clinical Diagnostic Laboratories 2 Pidgeon Hill Dr., Suite 150, Sterling, VA 20165 44355 Premier Plaza, Suite 240, Ashburn, VA 20147 Email: info@clinicaldiagnosticlab.com Phone: (703) 430-1111 Fax: (703) 722-3890

Thyroglobulin Antibody Ordering Recommendation Not recommended in the initial evaluation of autoimmune thyroid disease. Most often used to evaluate potentially unreliable thyroglobulin measurements in thyroid carcinomas. Mnemonic ATHYG Performed Mon-Sat Methodology Quantitative Chemiluminescent Immunoassay Reported Within 24 hours New York DOH Approval Status This test is New York DOH approved. Specimen Required Patient Preparation: Collect: Serum separator tube. Specimen Preparation: Transfer 0.5 mL serum to a Standard Transport Tube. (Min: 0.3 mL) Also acceptable: Heparinized plasma. Storage/Transport Temperature: Refrigerated. Unacceptable Conditions: EDTA plasma. Grossly hemolyzed or lipemic specimens. Remarks: Stability: After separation from cells: Ambient: 8 hours; Refrigerated: 1 week; Frozen: 6 months Reference Interval 0.0 - 4.0 IU/mL Interpretive Data A value of 4.0 IU/mL or less indicates a negative result for thyroglobulin antibodies. The Thyroglobulin Antibody assay is being performed using the Beckman Coulter Access Dxl method. Compliance Category: FDA Note CPT Code 86800 Components Component Chart Name Thyroglobulin Antibody Component Test Code 0050105 LOINC 8098-6 Aliases ANTI-THYROGLOBULIN ANTIBODY THYROGLOBULIN ANTIBODY

Allergen, Food, Whole Egg, IgG Ordering Recommendation Not recommended for initial thyroid disorders testing. Distinguish thyroid autoimmune disorders from nonautoimmune disease or hypothyroidism. Mnemonic EGGWHOLE Methodology Quantitative ImmunoCAP Fluorescent Enzyme Immunoassay Performed Mon-Sat Reported 1-8 days New York DOH Approval Status This test is New York DOH approved. Specimen Required Patient Preparation: Collect: Serum separator tube (SST). Specimen Preparation: Separate serum from cells ASAP or within 2 hours of collection. Storage/Transport Temperature: Refrigerated. Unacceptable Conditions: Hemolyzed, icteric, or lipemic specimens. Remarks: Stability: Ambient: 48 hours; Refrigerated: 2 weeks; Frozen: 1 year Reference Interval Less than 30.21 mcg/mL Interpretive Data Values less than 2.00 mcg/mL represent absent or undetectable levels of allergen-specific IgG antibody. This test has not been cleared or approved by the US Food and Drug Administration. This test was performed in a CLIA certified laboratory and is intended for clinical purposes. Compliance Category: FDA Note CPT Code 86001 Components Component Chart Name Allergen, Food, Whole Egg IgG Component Test Code 2011820 LOINC 45201-1 Aliases