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The Terms and Conditions of Clinical Diagnostic Laboratories located in Sterling and Ashburn is located on this page. Terms & Conditions 1. Acceptance of Terms Welcome to Clinical Diagnostic Laboratories ("we," "us," or "our"). By accessing or using our services, including our website and any related applications (collectively referred to as the "Services"), you agree to comply with and be bound by these Terms and Conditions. If you do not agree to these terms, please refrain from using our Services. 2. Services Offered Clinical Diagnostic Laboratories provides comprehensive diagnostic testing services including, but not limited to, blood panels, allergy tests, COVID tests, and Influenza tests. These services are available at our two separate locations: 2 Pidgeon Hill Dr., Suite 150, Sterling, VA 20165, and 44355 Premier Plaza, Suite 240, Ashburn, VA 20147. 3. Test Accuracy and Interpretation While we strive to provide accurate and reliable test results, it is important to note that medical tests may have limitations and potential variations. Test results should be interpreted by qualified medical professionals, and we strongly recommend consulting a healthcare provider for accurate diagnosis and treatment recommendations based on the test results. 4. Privacy and Data Security We are committed to protecting your privacy and the security of your personal and medical information. Our Privacy Policy outlines the types of data we collect, how it is used, and the measures we take to safeguard your information. By using our Services, you agree to our Privacy Policy. 5. Payment and Billing We offer various payment options for our services. Payment details, including pricing and payment methods, are available on our website and will be provided during the checkout process. Any additional fees, taxes, or charges associated with the services will be clearly communicated. 6. Appointments and Cancellations Appointments for tests are subject to availability and can be scheduled through our website or by contacting our customer service. If you need to cancel or reschedule an appointment, please provide notice in advance according to our cancellation policy, which will be communicated during the appointment scheduling process. 7. Test Preparation Instructions Specific tests may require certain preparations, such as fasting or medication restrictions. Customers are responsible for following these instructions to ensure accurate test results. 8. Turnaround Time for Results We strive to provide test results within a specific timeframe. However, factors such as test complexity and demand may impact the turnaround time. 9. Refund and Return Policy If services are paid for but not utilized, our refund and return policy applies. Details can be found on our website or obtained by contacting customer service. 10. Communication Channels For inquiries, support, or appointment scheduling, contact us via email, phone, or our designated customer portal. 11. Insurance and Coverage Information about insurance coverage, billing procedures, and reimbursement for services covered by insurance can be found on our website or by contacting us directly. 12. Laboratory Accreditation and Certifications Clinical Diagnostic Laboratories maintains specific accreditations and certifications that demonstrate our commitment to q uality and accuracy. 13. Health and Safety Measures To ensure a safe testing environment, we adhere to rigorous health and safety protocols for the protection of both patients and staff. 14. Dispute Resolution Any disputes will be resolved through mediation or arbitration, with the applicable jurisdiction specified. 15. Legal Disclaimers Our services are for diagnostic purposes only. Customers should consult healthcare professionals for medical advice and treatment. 16. User Accounts (if applicable) If you create a user account on our platform, terms related to account creation, management, and security apply. 17. Governing Law These Terms and Conditions are governed by and construed in accordance with the laws of the state of Virginia, without regard to its conflict of laws principles. 18. Conta ct Us If you have any questions, concerns, or feedback regarding these Terms and Conditions or our Services, 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 an Allergen, Food, Whole Egg, IgG test for Clinical Diagnostic Laboratories. 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

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 food allergy panel for Clinical Diagnostic Laboratories. Allergens, Food, Common Adult Food IgE Ordering Recommendation Mnemonic FOOD ADULT Performed Sat-Sun Methodology Quantitative ImmunoCAP Fluorescent Enzyme Immunoassay Reported 1-3 Days New York DOH Approval Status This test is New York DOH approved. Specimen Required Patient Preparation: Multiple patient encounters should be avoided. Collect: Serum separator tube. Multiple specimen tubes should be avoided. Specimen Preparation: Separate serum from cells ASAP or within 2 hours of collection. Transfer 2.25 mL serum to a Standard Transport Tube. (Min: 1.04 mL) Storage/Transport Temperature: Refrigerated. Unacceptable Conditions: Hemolyzed, icteric, or lipemic specimens. Remarks: Stability: After separation from cells: Ambient: 48 hours; Refrigerated: 2 weeks; Frozen: 1 year Reference Interval Test Number Components Reference Interval Immunoglobulin E Age Reference Interval (kU/L) 0-5 months 13 or less 6-12 months 34 or less 1-2 years 97 or less 3 years 199 or less 4-6 years 307 or less 7-8 years 403 or less 9-12 years 696 or less 13-15 years 629 or less 16-17 years 537 or less 18 years and older 214 or less Less than or equal to 0.34 kU/L Less than or equal to 0.34 kU/L Allergen, Food, Egg White IgE Allergen, Food, Milk (Cow) IgE Less than or equal to 0.34 kU/L Less than or equal to 0.34 kU/L Less than or equal to 0.34 kU/L Less than or equal to 0.34 kU/L Allergen, Food, Peanut IgE Allergen, Food, Shrimp IgE Allergen, Food, Soybean IgE Allergen, Food, Wheat IgE Less than or equal to 0.34 kU/L Less than or equal to 0.34 kU/L Allergen, Food, Codfish IgE Allergen, Food, Corn IgE Less than or equal to 0.34 kU/L Less than or equal to 0.34 kU/L Allergen, Food, Walnut (Juglans spp) IgE Allergen, Food, Clam IgE Less than or equal to 0.34 kU/L Allergen, Food, Scallop IgE Reference Interval Allergen results of 0.10-0.34 kU/L are intended for specialist use as the clinical relevance is undetermined. Even though increasing ranges are reflective of increasing concentrations of allergen-specific IgE, these concentrations may not correlate with the degree of clinical response or skin testing results when challenged with a specific allergen. The correlation of allergy laboratory results with clinical history and in vivo reactivity to specific allergens is essential. A negative test may not rule out clinical allergy or even anaphylaxis. Reporting Range (reported in kU) Class Scoring Probability of IgE Mediated Clinical Reactionported in kU) Less than 0.10 No significant level detected 0 0.10-0.34 Clinical relevance undetermined 0/1 0.35-0.70 Low 1 0.71-3.50 3.51-17.50 Moderate High 2 3 17.51-50.00 Very High 4 50.01-100.00 Very High 5 Greater than 100.00 Very High 6 Compliance Category: FDA Note Allergens included in this panel: Clam, Egg White, Codfish/Whitefish, Corn, Milk (Cow's), Peanut, Shrimp, Scallop, Soybean, Walnut, Wheat, and IgE Serum Total CPT Code 86003 x11; 82785 Components Component Test Code Component Chart Name LOINC 19113-0 Allergen, Food, Egg White IgE Allergen, Food, Peanut IgE Allergen, Food, Shrimp IgE Allergen, Food, Milk (Cow) IgE 6106-9 7258-7 6206-7 6246-3 Immunoglobulin E 0050345 0055013 0055020 0055024 0055030 Allergen, Food, Soybean IgE Allergen, Food, Wheat IgE 6248-9 6276-0 0055031 0055034 Allergen, Food, Codfish IgE Allergen, Interp, Immunocap Score IgE 6082-2 33536-4 0055036 0055041 Allergen, Food, Corn IgE Allergen, Food, Walnut (Juglans spp) IgE 6087-1 33536-4 0055078 0055209 Allergen, Food, Clam IgE Allergen, Food, Scallop IgE 6076-4 7691-9 0099488 0099495

The product page for the Complete Food Allergy Panel for Clinical Diagnostic Laboratories. Complete Food Allergy Scan Uncover what’s really bothering your body. This food allergy panel tests for common food allergens that may be triggering your symptoms — from digestive discomfort and skin reactions to fatigue and inflammation. Whether you're managing known allergies or looking for answers, this test gives you clarity and peace of mind. Here’s what it checks — and why it matters: IgE Total, Serum – A general screening that measures your overall allergic sensitivity. Specific Food Allergens – Detects allergic reactions to 15 of the most common trigger foods: Sesame Seed Hazelnut Shrimp Walnut Soybean Egg White Cashew Scallop Cod Almond Cow’s Milk Salmon Tuna Peanut Wheat Whether you’re dealing with unexplained symptoms or managing a diagnosed allergy, this panel helps identify specific food triggers — so you can make informed choices, feel better, and take back control of your diet. One simple blood draw. No skin pricks, no guesswork, and no doctor’s order required. $155.00 Taxes will be calculated at checkout Buy Now

Ordering information regarding a Glomerular Basement Membrane Antibody test for Clinical Diagnostic Laboratories. Glomerular Basement Membrane Antibody, IgG (IFA) Ordering Recommendation May be useful in detecting glomerular basement membrane (GBM) antibodies. Combined use of IFA Glomerular Basement Membrane Antibody, IgG by Multiplex Bead Assay and IFA (2008403 ) may improve diagnostic sensitivity for disease. If positive, may be useful for monitoring treatment response. Mnemonic GBM-G IFA Performed Mon-Sat Methodology Indirect Fluorescent Antibody 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. Transport 1 mL serum. (Min: 0.5 mL) Storage/Transport Temperature: Refrigerated. Unacceptable Conditions: Remarks: Stability: After separation from cells: Ambient: 48 hours; Refrigerated: 2 weeks; Frozen: 1 year (avoid repeated freeze/thaw cycles) Reference Interval Negative Interpretive Data When present, IgG antibody to glomerular basement membrane (GBM) antigen detected by either indirect fluorescent antibody (IFA) or multiplex bead assay helps support a diagnosis of Goodpasture syndrome. However, the combined result of both assays performed during initial evaluation improves the diagnostic sensitivity for disease. A positive result in one or both assays should be confirmed by renal biopsy. This test was developed and its performance characteristics were determined by CDL. It 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 86255 Components Component Chart Name GBM Antibody, IgG by IFA Component Test Code 0049191 LOINC 29994-1 Aliases Anti-GBM Antibody Anti-Glomerular Basement Membrane Antibody GBM IgG IFA

Ordering information regarding a Tissue Transglutaminase (tTG) IgA test for Clinical Diagnostic Laboratories. Tissue Transglutaminase (tTG) IgA Ordering Recommendation Recommended single screening test for IgA-competent individuals with suspected celiac disease. (IgA testing recommended to identify IgA competence.). May aid in monitoring adherence to gluten-free diet in celiac disease-confirmed patients. Mnemonic Methodology Semi-Quantitative Enzyme-Linked Immunosorbent Assay 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: Separate serum from cells ASAP or within 2 hours of collection. Transfer 0.5 mL serum to a Standard Transport Tube. (Min: 0.3 mL) Storage/Transport Temperature: Frozen. Unacceptable Conditions: Refrigerated. Remarks: Stability: After separation from cells: Ambient: 48 hours; Refrigerated: 2 weeks; Frozen: 1 year (avoid freeze/thaw cycles) Reference Interval 3 U/mL or less 4-10 U/mL Negative Weak Positive 11 U/mL or greater Positive Interpretive Data Presence of the tissue transglutaminase (tTG) IgA antibody is associated with glutensensitive enteropathies such as celiac disease and dermatitis herpetiformis. tTG IgA antibody concentrations greater than 40 U/mL usually correlate with results of duodenal biopsies consistent with a diagnosis of celiac disease. For antibody concentrations greater or equal to 4 U/mL but less than or equal to 40 U/mL, additional testing for endomysial (EMA) IgA concentrations may improve the positive predictive value for disease. Note Testing for tTG IgA antibodies is recommended as an initial screen to identify patients at risk for celiac disease, and in whom duodenal biopsy should be performed to confirm disease. Some patients may have positive tTG IgA but negative EMA IgA and/or deamidated gliadin peptide (DGP) IgA results, which may be associated with false positivity or may indicate early disease. Close clinical correlation with continued testing may be indicated in patients with a family history of or who are at increased risk for celiac disease. A positive serology but normal biopsy may also indicate a gluten-free diet (GFD) prior to testing, latent disease, or early enteropathy. Re-challenge with a gluten diet may be recommended if GFD had been initiated prior to subsequent testing. In the case of latent or early disease, HLA DQ2 and DQ8 testing may be necessary to determine risk for disease. For patients with a high degree of suspicion for celiac disease and who test negative for tTG, EMA and/or DGP IgA tests, selective IgA deficiency should be considered and testing for tTG, EMA and/or DGP IgG antibodies performed. If serology is negative and suspicion for celiac disease is strong, intestinal biopsy may be warranted. Biopsy is particularly important for patients with diarrhea, steatorrhea, weight loss, failure to thrive, or with inherited genetic deficiencies such Down or Turner syndrome. CPT Code 86364 Components Component Chart Name Tissue Transglutaminase (tTG) Ab, IgA Component Test Code 0097709 LOINC 46128-5 Aliases Human RBC tTG Native tTG TG2 IgA Tissue Transglutaminase Tissue Transglutaminase Ab IgA tTG IgA tTG, IGA

Ordering information regarding a Serine Proteinase 3 (PR3) Antibody for Clinical Diagnostic Laboratories. Serine Proteinase 3 (PR3) Antibody Ordering Recommendation When used in conjunction with other autoantibody tests (ANCA, MPO), may aid in differentiating suspected Wegener granulomatosis (WG) from other vasculitides. May be useful to monitor patients with PR3 antibodies. 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 PR3 Performed Mon-Sat Methodology Semi-Quantitative Multiplex Bead 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: 0.2 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 85% of patients with a C-ANCA pattern by IFA have antibodies specific for PR3. Compliance Category: FDA Note CPT Code 83516 Components Component Chart Name Serine Proteinase 3 (PR3) Ab, IgG Component Test Code 0050527 LOINC 6968-2 Aliases PR3 PR3 Ab PR3 IgG Antibodies

Ordering information regarding a Hemoglobin A1C test for Clinical Diagnostic Laboratories. Hemoglobin A1C Ordering Recommendation The Hemoglobin A1c test is a vital tool for diagnosing and monitoring diabetes mellitus, as well as assessing prediabetes. Diagnostic levels are marked by values greater than or equal to 6.5%, while monitoring involves tracking long-term glycemic control in diabetes patients. Additionally, values between 5.7% and 6.4% signal an increased risk of developing diabetes. For patients with hemoglobin variants lacking hemoglobin A, the Fructosamine test is preferred for monitoring long-term glycemic control. Mnemonic Methodology Quantitative Capillary Electrophoresis Performed Mon-Sat Reported Within 1-2 days New York DOH Approval Status This test is New York DOH approved. Specimen Required Patient Preparation: Collect: Lavender (EDTA) Specimen Preparation: Transport whole blood in original tube. (Min: 1 mL) Storage/Transport Temperature: Refrigerated. Unacceptable Conditions: Tissue or urine. Samples frozen after 8 hrs of collection and samples frozen at temperatures less than -70C. Remarks: Stability: Ambient: 72 hours; Refrigerated: 1 week; Frozen: 3 months (Must be frozen within 8 hrs of collection at -70 to -80C) Reference Interval Components Available Separately Reference Interval No Hemoglobin A1C Less than 5.7 percent No Estimated Average Glucose By report Interpretive Data HbA1c values of 5.7-6.4 percent indicate an increased risk for developing diabetes mellitus. HbA1c values greater than or equal to 6.5 percent are diagnostic of diabetes mellitus. For diagnosis of diabetes in individuals without unequivocal hyperglycemia, results should be confirmed by repeat testing. Note This assay accurately measures hemoglobin A1c even in the presence of hemoglobin variants, provided hemoglobin A is present. For patients with known hemoglobin variants who lack hemoglobin A, it is recommended to monitor long-term glycemic control using the Fructosamine test CPT Code 83036 Components Component Test Code 0070427 0070428 Component Chart Name Estimated Average Glucose LOINC Hemoglobin A1C 27353-2 4548-4 Aliases Hemoglobin A1C A1C A1C Hemoglobin Glycated Hemoglobin Glyco HGB Glyco-Hb Glycosylated Hemoglobin HA1C HbA1c Hemoglobin A1C Hemoglobin A1C, Blood

Ordering information regarding a Cardiolipin Antibody, IgM test for Clinical Diagnostic Laboratories. Beta-2 Glycoprotein 1 Antibody, IgA Ordering Recommendation Preferred second-line test when seronegative antiphospholipid syndrome (APS) is strongly suspected. Order incrementally or concurrently with other noncriteria antiphospholipid antibody tests. May also be useful in estimating risk of thrombosis and/or pregnancy-related morbidity in patients with SLE. Mnemonic B2GPI A 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. Storage/Transport Temperature: Refrigerated. Unacceptable Conditions: Plasma or other body fluids. 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 SAU Interpretive Data Compliance Category: FDA Note MPL = IgM phospholipid units CPT Code 86146 Components Component Chart Name B2Glycoprotein 1, IgA Antibody Component Test Code 0050324 LOINC 21108-6 Aliases Anti-B2-Glycoprotein 1 Anti-B2-Glycoprotein I Anti-B2-GP 1 Anti-B2-GP I Anti-B2-GP1 Anti-B2-GPI Anti-Beta-2-Glycoprotein I APOH Apolipoprotein H B2 IgA B2-glycoprotein 1 IgA B2GP1 IgA Beta 2GP1 Ab