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Ordering information regarding an HPV Self Collection Screen for Clinical Diagnostic Laboratories. HPV Self-Collection Screening (HPV-SCS) Ordering Recommendation The HPV Cervical Cancer Self-Collection Test is a highly sensitive screening tool that enables patients to collect their own vaginal sample using an FDA-approved device. After collection, the specimen is processed using advanced nucleic acid amplification methods (typically PCR-based) to qualitatively detect high-risk HPV DNA associated with cervical cancer. This self-collected approach offers comparable diagnostic accuracy to traditional clinician-collected samples while minimizing discomfort and barriers associated with pelvic examinations, making it an effective option for early detection and timely clinical follow-up. Mnemonic HPV Self-Collection Screening (HPV-SCS) Methodology The specimen is processed using nucleic acid amplification techniques (generally PCR-based methods) to qualitatively detect the presence of high-risk HPV DNA. Performed Mon-Sat Reported Within 3-5 days Specimen Required Patient Preparation: Collect: Wash your hands and remove the sterile self-collection device before gently inserting it into the vagina up to the indicated marker. Rotate the device 2–3 times as instructed to collect an adequate sample, then carefully withdraw it. Refrain from douching, using intravaginal medications, or applying topical agents for at least 48 hours prior to collection. • Avoid sexual intercourse for 24–48 hours before sample collection. • If menstruating, confirm with the provider whether sample collection should be postponed until menses have ceased. Specimen Preparation: Immediately place the collection device into the provided vial containing the appropriate viral transport medium. Secure the vial cap tightly and gently invert the vial to mix the specimen with the medium. Ensure that the specimen is labeled accurately with patient identification and collection date/time. Storage/Transport Temperature: Maintain at 2–8°C during storage and transport. Avoid freezing unless the test kit instructions specifically allow it. Prompt transport to the laboratory is advised to maintain sample integrity. Unacceptable Conditions: Specimens that are unlabeled or improperly labeled. Inadequate sample volume or insufficient cellular material. Contaminated samples (e.g., with menstrual blood or external substances) beyond acceptable limits. Specimens showing leakage or compromised container integrity. Samples exposed to temperatures outside the recommended range prior to processing Remarks: Specimen source required. Stability: Reference Interval Negative Interpretive Data A positive result should be correlated with clinical history and may necessitate additional diagnostic procedures. Careful patient education on follow-up steps and interpretation of results is essential. This test should be used as a screening tool only; abnormal findings must be evaluated in conjunction with other clinical assessments. Note CPT Code 87624 Aliases HPV Cervical Cancer Self-Collection Self-Collected HPV Test HPV DNA Test (Self-Collected) Cervical HPV Self-Sampling

Ordering information regarding an ACTH test for Clinical Diagnostic Laboratories. ACTH by Immunohistochemistry Ordering Recommendation Mnemonic Methodology Immunohistochemistry Performed Mon-Sat Reported 1-3 days New York DOH Approval Status This test is New York DOH approved. Specimen Required Patient Preparation: Formalin fix (10 percent neutral buffered formalin) and paraffin embed specimen (cells must be prepared into a cellblock). Protect paraffin block and/or slides from excessive heat. Transport tissue block or 5 unstained (3- to 5-micron thick sections), positively charged slides in a tissue transport kit Collect: Tissue or Cells Specimen Preparation: After drawing blood into an EDTA tube, label it with the patient's details. Keep the specimen at room temperature (15-30°C) if transporting within a few hours. For longer transport, place it in a biohazard bag within a cooler with ice packs, maintaining 2-8°C. Deliver it to the lab within 24 hours. Storage/Transport Temperature: Room temperature or refrigerated. Ship in cooled container during summer months. Unacceptable Conditions: Specimens submitted with non-representative tissue type. Depleted specimens. Remarks: Stability: Ambient: Indefinitely; Refrigerated: Indefinitely; Frozen: Unacceptable Reference Interval Components Available Separately Reference Interval Interpretive Data Note This test is performed as a stain and return (technical) service only. CPT Code 88342 Components Component Test Code 2003428 2003429 Component Chart Name ACTH by IHC LOINC ACTH Reference Number 94736-6 Aliases ACTH ACTH Antibody Staining ACTH by IHC

Ordering information regarding a T- Uptake test for Clinical Diagnostic Laboratories. Thyroxine, Free (Free T4) Ordering Recommendation The preferred alternative to this test is Thyroxine, Free (Free T4) Methodology Quantitative Electrochemiluminescent Immunoassay (ECLIA) Performed Mon-Sat Reported Within 24 hours New York DOH Approval Status This test is New York DOH approved. Specimen Required Patient Preparation: Collect: Serum separator tube or plasma separator tube. Also acceptable: Green (lithium heparin), lavender Specimen Preparation: Allow specimen to clot completely at room temperature. Separate serum or plasma from cells ASAP or within 2 hours of collection. Storage/Transport Temperature: Refrigerated. Unacceptable Conditions: Grossly hemolyzed specimens. Remarks: Stability: After separation of cells: Ambient: 8 days; Refrigerated: 2 weeks; Frozen: 2 years Reference Interval Free Thyroxine, ng/dL 0-3 days 0.7-2.7 ng/dL 4-30 days 0.8-3.1 ng/dL 1-23 months 2-6 years 0.5-2.3 ng/dL 0.9-1.8 ng/dL 7-11 years 0.9-1.7 ng/dL 12-19 years 12-19 years 0.9-1.6 ng/dL 0.9-1.6 ng/dL 20 years and older 0.9-1.7 ng/dL Pregnancy, 1st Trimester 0.9-1.4 ng/dL Pregnancy, 2nd Trimester 0.7-1.3 ng/dL Interpretive Data Thyroxine, Free (Free T4) is the preferred test alternative for T Uptake and Free Thyroxine Index tests. Note CPT Code 84439 Components Component Test Code Component Chart Name LOINC 0070138 Thyroxine Free 3024-7 Aliases Free Thyroxine FT4, Serum Non-Protein Bound Tetraiodothyronine T4 Free, Serum T4, Free Thyroid Function Cascade

Ordering information regarding a HPV Assay Test for Clinical Diagnostic Laboratories. Human Papillomavirus (HPV), High Risk with 16 and 18 Genotype by Liquid-Based Pap Test and Hologic Thin Prep Ordering Recommendation This FDA-approved test and platform is designed for primary HPV screening in individuals aged 25 and older with a cervix. It is also FDA-approved for routine cervical cancer screening in combination with cervical cytology (Pap smear) for those aged 30 and older. Additionally, it serves as a follow-up test for abnormal cytology results in individuals aged 21 and older. Mnemonic Methodology Qualitative Polymerase Chain Reaction Performed Mon-Sat Reported Within 1-5 days Specimen Required Patient Preparation: Collect: Cervical, anal, or vaginal specimen with brush or spatula from ThinPrep kit and place in PreservCyt Media Specimen Preparation: Mix well. Transfer 3 mL to a Standard Transport Tube. (Min 1.5 mL). For primary screening purposes, please submit a specimen aliquot and keep the original specimen at the client site. Storage/Transport Temperature: Refrigerated Unacceptable Conditions: Bloody or dark brown specimens. Specimens in any media other than indicated above. Remarks: Specimen source required. Stability: Ambient: 6 months; Refrigerated: 6 months; Frozen: Unacceptable Reference Interval Negative Interpretive Data This test detects the DNA of HPV16, HPV18, and 12 other high-risk HPV types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) that are linked to cervical cancer and its precursor lesions. The accuracy of the results may be influenced by specimen collection methods, the infection stage, and the presence of interfering substances. It's crucial to interpret these results alongside other laboratory and clinical data. A negative high-risk HPV result does not rule out the presence of other high-risk HPV types, potential future cytologic abnormalities, underlying CIN2-3, or cancer. HPV testing is not recommended for the screening or management of atypical squamous cells of undetermined significance (ASCUS) in women under 21 years of age. Note CPT Code 87624 Components Component Chart Name Component Test Code LOINC HPV Source 0060752 31208-2 2011935 HPV Genotype 16 by PCR 77399-4 2011936 2011941 HPV, Other High Risk by PCR 82675-0 HPV Genotype 18 by PCR 77400-0 Aliases HPV High Risk HPV HR ThinPrep HPV Primary screening Human papilloma virus

Did you have a test with Clinical Diagnostic Laboratories? Check here to access your results. Patient Test Results If you provided a doctor's order/referral, your results will be delivered to your physician either via fax or via their portal (if they have established an account with us). If you did not provide an order/referral, your results will be sent to you directly via email in the form of a PDF file. Patients are able to request a copy of their results at any time. If you'd like to request a copy of your lab results, please contact us using the button below. Email Us About Lab Results

Ordering information regarding a Anti-Mitochondrial Antibody (AMA) test for Clinical Diagnostic Laboratories. 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

The Privacy Policy of Clinical Diagnostic Laboratories located in Sterling and Ashburn is located on this page. 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

Ordering information regarding a Tryptase test for Clinical Diagnostic Laboratories. SARS-CoV-2 (COVID-19) Ordering Recommendation Use to detect the novel coronavirus (SARS-CoV-2). Mnemonic Methodology Qualitative Nucleic Acid Amplification (NAA) Performed Mon-Sat Reported 1-2 days New York DOH Approval Status This test is New York DOH approved. Specimen Required Patient Preparation: Collect: Nasopharyngeal swab, oropharyngeal swab, nasal swab, or saliva. To ensure the highest quality results, a nasopharyngeal swab is recommended. Specimen Preparation: Nasopharyngeal swab: Place in viral transport media Liquid Amies, or saline (minimum volume 1.2mL). Place each specimen in an individually sealed bag. Oropharyngeal or nasal swab: Place in viral transport media Liquid Amies, or saline (minimum volume 1.2mL). Swab Collection Kit. Place each specimen in an individually sealed bag. Saliva: Transport in COVID-19 Saliva Collection Tube Storage/Transport Temperature: Frozen. Unacceptable Conditions: Undiluted saliva. Saliva submitted in anything other than a Saliva Collection Tube. Swabs not in media. Wood swabs, calcium alginate swabs. Media with guanidine-containing materials, 'molecular media' that indicates inactivation of pathogens and preservation of RNA/DNA, charcoal media. Specimens sent in tubes with pop-top lids/caps. Specimens in glass tubes. Remarks: Stability: Swabs: Ambient: Unacceptable; Refrigerated: 2 days; Frozen: 1 month Saliva: Ambient: 5 days; Refrigerated: 5 days, Frozen: 5 days Reference Interval Interpretive Data This test should be ordered for the detection of the 2019 novel coronavirus SARS-CoV-2 in individuals who meet SARS-CoV-2 clinical and/or epidemiological criteria. The Coronavirus SARS-CoV-2 (COVID-19) by nucleic acid amplification test is for in vitro diagnostic use under the FDA Emergency Use Authorization (EUA) for U.S. laboratories certified under CLIA to perform high complexity tests. Not Detected results do not rule out the presence of PCR inhibitors in the patient specimen or assay-specific nucleic acid in concentrations below the level of detection by the assay. Detected results are indicative of the presence of SARS-CoV-2 RNA. Due to the complexity of nucleic acid amplification methodologies, there may be a risk of false-positive results. Clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Reliable results are dependent on adequate specimen collection, transport, storage, and handling. Compliance Category: Depends on Specimen/Source/Method Note CPT Code 87635 Components Component Chart Name SARS-CoV-2 Source Component Test Code 3002639 LOINC 31208-2 3002640 SARS-CoV-2 by NAA 94500-6 Aliases 2019-nCoV Coronavirus disease - 2019 COVID-19 COVID-19 Illness COVID-2019 SARS-CoV-2

Ordering information regarding a Deamidated Gliadin Peptide (DGP) Antibody, IgG test for Clinical Diagnostic Laboratories. Deamidated Gliadin Peptide (DGP) Antibody, IgG Ordering Recommendation Acceptable single screening test for celiac disease. IgA testing recommended to identify IgA deficiency. Use IgG test in individuals who are IgA deficient. May be useful in diagnosing children <2 years who test negative for tTG and EMA antibodies. May aid in monitoring adherence to gluten-free diet. Celiac Disease Reflexive Cascade (2008114 ) or Tissue Transglutaminase (tTG) Antibody, IgG (0056009 ) is the preferred test for screening patients with suspected celiac disease. Mnemonic Methodology Semi-Quantitative Enzyme-Linked Immunosorbent Assay Performed Mon-Sat Reported 1-2 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. Transport 0.5 mL serum. (Min: 0.3 mL) Storage/Transport Temperature: Refrigerated Unacceptable Conditions: Plasma or other body fluids. Contaminated, hemolyzed, grossly icteric, or grossly lipemic specimens. Remarks: Stability: After separation from cells: Ambient: 48 hours; Refrigerated: 2 weeks; Frozen: 1 year Reference Interval 19 Units or less 20-30 Units Negative Weak Positive 31 Units or greater Positive Interpretive Data Note CPT Code 86258 Components Component Chart Name Deamidated Gliadin Peptide (DGP) Ab, IgG Component Test Code 0051359 LOINC 63459-2 Aliases Celiac Disease Antibodies Deamidated Gliadin Antibodies (DGP) Deaminated Gliadin Peptide Antibodies DGP DGP Ab DGP IgA

Ordering information regarding a Comprehensive Metabolic Panel test for Clinical Diagnostic Laboratories. Comprehensive Metabolic Panel Ordering Recommendation Mnemonic Methodology Quantitative Ion-Selective Electrode/Quantitative Enzymatic Assay/Quantitative Spectrophotometry Performed Mon-Sat Reported Within 24 hours New York DOH Approval Status This test is New York DOH approved. Specimen Required Patient Preparation: Collect: Serum separator tube (SST). Specimen Preparation: Protect from light. Allow serum tube to clot completely at room temperature. Separate serum or plasma from cells ASAP or within 30 minutes of collection. Transfer 1 mL serum or plasma to an Amber Transport Tube. (Min: 0.5 mL) Storage/Transport Temperature: Refrigerated Unacceptable Conditions: EDTA, citrate, oxalate, or sodium fluoride/potassium oxalate. Remarks: Stability: After separation from cells: Ambient: Calcium and CO2: 4 hours, All others: 24 hours; Refrigerated: 1 week; Frozen: 2 weeksated: 2 weeks; Frozen: 1 year (avoid repeated freeze/thaw cycles) Reference Interval 19 Units or less 20-39 Units Negative Weak Positive 40-59 Units Moderate Positive 60 Units or Greater Strong Positive Interpretive Data Note Tests included in this panel: Albumin, Serum or Plasma (0020030), Alkaline Phosphatase, Serum or Plasma (0020005), Aspartate Aminotransferase, Serum or Plasma (0020007), Alanine Aminotransferase, Serum or Plasma (0020008), Bilirubin, Total, Serum or Plasma (0020032), Calcium, Serum or Plasma (0020027), Carbon Dioxide, Serum or Plasma (0020004), Creatinine, Serum or Plasma (0020025), Chloride, Serum or Plasma (0020003), Glucose, Serum or Plasma (0020024), Potassium, Plasma or Serum (0020002), Protein, Total, Plasma or Serum (0020029), Sodium, Plasma or Serum (0020001), and Urea Nitrogen, Plasma or Serum (0020023). CPT Code 80053 Components Component Chart Name Component Test Code LOINC Sodium, Serum or Plasma 0020001 2951-2 0020002 Potassium, Serum or Plasma 2823-3 0020003 0020004 Chloride, Serum or Plasma 2075-0 Carbon Dioxide, Serum or Plasma 2028-9 0020005 0020007 Alkaline Phosphatase 6768-6 Aspartate Aminotransferase 1920-8 0020008 0020023 Alanine Aminotransferase 1742-6 Urea Nitrogen, Serum or Plasma 0020024 0020025 3094-0 Glucose, Serum or Plasma Creatinine, Serum or Plasma 2345-7 2160-0 0020027 0020029 Calcium, Serum or Plasma Protein Total, Serum/Plasma 17861-6 2885-2 0020030 0020032 Albumin, Serum or Plasma Bilirubin, Total, Serum or Plasma 1751-7 1975-2 0020396 3004293 Anion Gap UH EGFR 33037-3 Aliases ACPA Antibody Anti Citrulline Anti-CCP C12 Chem 12 Chemistry Panel Chemistry Screen CMP SMA 12 SMA 20 SMAC