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- Home | Clinical Diagnostic Laboratories
Clinical Diagnostic Laboratories is an affordable and efficient medical laboratory located in Northern Virginia in Sterling, VA and in Ashburn, VA just minutes from One Loudoun. At our facility, we strive to provide the highest possible quality testing for doctors, companies and organizations, and for individual patients. The DMV's Most Trusted Lab for Fast, Accurate, and Reliable Testing–Every Time From routine panels to advanced diagnostics, we deliver results you can trust with speed you can count on. About Us Schedule An Appointment Pre-Built Panels Ashburn 44355 Premier Plaza Suite 230, Ashburn, VA 20165 Schedule An Appointment OUR CURRENT HOURS ARE: Monday 9am - 4pm Tuesday 9am - 4pm Wednesday 9am - 4pm Thursday 9am - 4pm Friday 9am - 4pm Saturday 10am - 2pm* Sunday: Closed* *Appointments are highly recommended on Monday-Saturdays and major Holidays are by appointment only Please contact us ahead of time to verify if walk-ins are available. Schedule An Appointment ABOUT CLINICAL DIAGNOSTIC LABORATORIES Preferred Diagnostic Center in Loudoun County Our main goal is to provide an alternative testing facility for individuals: doctors, as well as hospitals that is affordable and convenient. What makes Clinical Diagnostics Laboratories different from the others? We provide excellent service with a personal and friendly touch. We have an on-call Director at the Lab who has a Ph.D. in Pathology. Our Full-time Technologist has over ten years of experience in the Medical Lab field. Clinical Diagnostic Laboratories has grown quickly throughout the area with respect to returning individuals, referrals and walk-ins because we treat our patients with dignity and respect. About Us “Clinical Diagnostic Laboratories is recognized as the TOP Diagnostic Lab for the Northern Virginia, Washington, DC and Maryland regions and is featured on the TOP Doctors Interviews which are seen on CNN Headline News, MSNBC, Oprah Winfrey Network, BRAVO and other networks” Services We Provide Our laboratory provides services for a variety of organizations and companies across a wide array of industries. Whether you're a private organization, government contractor, medical facility, small to large company, or something else entirely, we have the resources to help you achieve your desired goals. Please inquire for more information. View All Services No Insurance Required - Try Our Pre-Built Panels Our pre-built lab panels offer a fast, affordable way to check in on your health—no insurance or doctor’s order required. Whether you're monitoring your wellness, checking vitamin levels, or screening for common conditions, we've bundled the most important tests into convenient packages. Simple pricing, quick results, and expert local service make it easy to take control of your health on your terms. Order a Health Panel We Can Come to You! Getting your blood drawn can help you identify issues before they happen. But scheduling an appointment can be difficult. Instead of worrying about a commute or taking time off from work, let us come to you. Whether it's an office space or your home, we can come to you and provide mobile blood draw services. Schedule A Mobile Blood Draw
- Contact | CDL
This is the Contact page for Clinical Diagnostic Laboratories. 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. 44355 Premier Plaza, Suite 240 Ashburn, VA 20147
- Hemoglobin A1C
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
- Lipid Panel
Ordering information regarding a Lipid Panel test for Clinical Diagnostic Laboratories. Lipid Panel Ordering Recommendation Use to assess cardiovascular disease risk and guide therapy. Mnemonic Methodology Quantitative Enzymatic Assay Performed Mon-Sat Reported Within 24 hours New York DOH Approval Status This test is New York DOH approved. Specimen Required Patient Preparation: Refer to individual components. Collect: Plasma separator tube or serum separator tube. Specimen Preparation: Allow serum tube to clot completely at room temperature. Separate serum or plasma from cells within 2 hours of collection. Transfer 1 mL serum or plasma to a standard transport tube. (Min: 0.5 mL) Storage/Transport Temperature: Refrigerated Unacceptable Conditions: Body fluid (refer to Cholesterol, Fluid; Triglycerides, Fluid; and Chylomicron Screen, Body Fluid). Remarks: Stability: After separation from cells: Ambient: 24 hours; Refrigerated: 7 days; Frozen: 3 months Reference Interval Interpretive Data An HDL cholesterol less than 40 mg/dL is low and constitutes a coronary heart disease risk factor. An HDL cholesterol greater than 60 mg/dL is a negative risk factor for coronary heart disease. Non-HDL cholesterol is a secondary target of therapy in persons with high serum triglycerides (greater than 199 mg/dL). The goal for non-HDL cholesterol in persons with high triglycerides is 30 mg/dL higher than their LDL cholesterol goal. CHD Risk Factors +1 Men, 45 years and older +1 Women, 55 years and older or premature menopause without estrogen therapy +1 Family history of premature CHD +1 Current smoking +1 Hypertension +1 Diabetes mellitus +1 Low HDL cholesterol: 39 mg/dL or less -1 High HDL cholesterol: 60 mg/dL or greater Desirable Adult Values Higher Risk Borderline Total Cholestorol Triglycerides 199 mg/dL or less 149 mg/dL or less 200-239 mg/dL 150-199 mg/dL 240 mg/dL or greater 200-499 mg/dL HDL Cholestorol LDL Cholesterol (calculated) 40 mg/dL or greater 129 mg/dL or less (99 mg/dL or less if patient has CHD) 39 mg/dL or less 130-159 mg/dL 160 mg/dL or greater VLDL Cholesterol (calculated) 30 mg/dL or less Desirable Children & Adolescents Higher Risk Borderline Total Cholestorol 169 mg/dL or less 170-199 mg/dL Triglycerides 149 mg/dL or less 150-199 mg/dL HDL Cholestorol LDL Cholesterol (calculated) 40 mg/dL or greater 109 mg/dL or less 110-129 mg/dL VLDL Cholesterol (calculated) 30 mg/dL or less 200 mg/dL or greater 200-499 mg/dL 39 mg/dL or less 130 mg/dL or greater Note CPT Code 80061 Components Component Test Code 0020031 0020040 0020051 0020053 0020551 0020705 0020008 0020023 0020024 0020025 0020027 0020029 0020030 0020032 0020396 3004293 Component Chart Name Sodium, Serum or Plasma Potassium, Serum or Plasma Chloride, Serum or Plasma Carbon Dioxide, Serum or Plasma Alkaline Phosphatase Aspartate Aminotransferase Alanine Aminotransferase Urea Nitrogen, Serum or Plasma Glucose, Serum or Plasma Creatinine, Serum or Plasma Calcium, Serum or Plasma Protein Total, Serum/Plasma Albumin, Serum or Plasma Bilirubin, Total, Serum or Plasma Anion Gap UH EGFR LOINC 2951-2 2823-3 2075-0 2028-9 6768-6 1920-8 1742-6 3094-0 2345-7 2160-0 17861-6 2885-2 1751-7 1975-2 33037-3 Aliases ACPA Antibody Anti Citrulline Anti-CCP C12 Chem 12 Chemistry Panel Chemistry Screen CMP SMA 12 SMA 20 SMAC
- Letter to Our Valued Patient | CDL
Learn why our practice no longer accepts PPO insurance or Anthem HealthKeepers, what this change means for your care, and how we continue to prioritize accessible, patient‑focused treatment. Dear Valued Patient, We understand that navigating lab testing and insurance coverage can be confusing, stressful, and sometimes frustrating. Many patients expect that medically necessary lab tests will be fully covered by their insurance, only to be surprised by bills or claim denials. We want to take a moment to explain why this happens, and what options are available to you. Why Insurance Coverage Can Be Complicated Insurance companies often control which laboratories they will reimburse, and many have exclusive agreements with specific “preferred” labs. Even if your doctor orders a test that is medically necessary and has a preferred laboratory they wish to send it to, insurance may refuse to pay if the lab performing it is not on the insurer’s approved list. In addition: Claims can be denied for administrative reasons, not because the test lacks medical necessity. In 2023, studies showed that nearly 1 in 5 claims across commercial plans were denied, with out-of-network labs denied more than one-third of the time. Negotiated rates may not reflect the true cost of testing, leaving smaller or independent labs out-of-network and limiting patient choice. Large insurers sometimes rely on high-volume national labs (like LabCorp or Quest), which must process thousands of samples and often face delays, lost specimens, or reporting outside the necessary timeframe . “Insurance networks and claim rules can make testing feel more like a barrier than a service. That’s why we focus on transparency and patient choice.” Your Options: Affordable, Transparent Self-Pay To make testing accessible and predictable, we offer affordable self-pay pricing. Because all of our testing is performed in-house, locally, we can provide: Lower prices than national lab chains Faster turnaround times Greater accuracy and reliability If you choose to pay out-of-pocket, we will provide a superbill containing everything your insurance company needs to process a claim. This includes: CPT codes for all tests performed Diagnosis codes Our provider identifiers (NPIs) Itemized charges and documentation We are happy to assist you with any additional paperwork or information your insurer may request. Even if the claim is initially denied, we can provide supporting documentation to help you appeal. “We want you to have control over your care — and the ability to submit claims to your insurance if you wish.” Why Our Lab is Different Unlike large national laboratories: Everything is processed locally, in-house, giving us control over quality and timing We avoid unnecessary shipping, which reduces risk of lost or misreported samples Our focus is on patient-centered service, not volume This means you get your results faster, accurately, and at a fraction of the cost. We Are Here to Help We understand this situation is not your fault, and it’s not your choice. Insurance networks, coverage rules, and reimbursement policies are complex — even for providers. Our commitment is simple: Provide high-quality testing you can trust Offer transparent, affordable pricing Support you in navigating insurance reimbursement whenever possible “With self-pay options and superbill support, you can access the testing you need without unnecessary delays or surprises.” Take Action Today We make it simple to access testing services on your terms: If you have questions or need guidance about insurance or billing, please contact our team — we are happy to walk you through every step. With care, The Team at Clinical Diagnostic Laboratories The Team at Clinical Diagnostic Laboratories View Our Self Pay Options >
- FAQs | CDL
Frequently asked questions 01 What is the CDL Partnership Program? The CDL Partnership Program is a free affiliate initiative that allows you to monetize your audience by promoting our online laboratory panels. When someone places an order using your unique discount code, you earn a commission on that sale. It’s a simple way to generate income while helping others access high‑quality diagnostic testing. 02 How do I earn commission as a CDL Affiliate? You earn commission whenever a customer purchases one of our online laboratory panels through your unique referral link or discount code. All referrals are automatically tracked from the moment they click your link through checkout, ensuring you receive credit for every qualifying sale. 03 When and how are commissions paid? Commissions are paid biweekly, and every referral you generate is tracked internally to ensure accuracy. As a partner, you’ll have full visibility into your activity through our shared tracking system, where you can view all sales and referral data in real time. Payments are issued once you’ve earned at least $50 within a pay period; if you don’t meet the minimum, your balance simply rolls over to the next cycle. If you want to refine payout rules, you can explore commission structure or payout thresholds. 04 Are there any costs involved in joining? No. The CDL Partnership Program is completely free to join. There are no fees, subscriptions, or required purchases. 05 Is there a cap on how much I can earn? No — there is no earning cap. Your income potential is entirely based on your audience size, engagement, and referral activity. 06 How can I keep track of my performance and earnings? Once your application is approved, you’ll receive access to our affiliate tracking spreadsheet, which provides a clear overview of your performance. Inside the dashboard, you can monitor your total sales, referral activity, earned commissions, and payout status—all in one place. This ensures you always have transparent, up‑to‑date insight into how your affiliate efforts are performing. If you want to enhance this section further, you can explore performance tracking or analytics best practices. 07 Who can I contact for CDL Partnership support? For questions or support, email our affiliate team at info@clinicaldiagnosticlab.com using the subject line: Re: Affiliate Support 08 How do I get my affiliate link and discount code? Affiliates receive their unique link and code immediately after approval, along with onboarding instructions. 09 How do I get lab results to use in the app? In order to get lab results to use within the app, you can download your lab results as a PDF from CDL's patient portal. Then, you can drag and drop the pdf or upload the PDF into the app. 10 Is this medical advice? No, no. The app gives general wellness tips and suggestions only. None of the suggestions provided in this app should be considered as medical advice. Always talk to a physician for specific suggestions tailored to your unique condition(s). 11 Can I view my Lab Results through this App? You can only view lab results you upload into the app. This app does not have direct service to our laboratory's LIS or patient portal. 12 Is my Data Safe? Yes, your data stays private, secure, and is uniquely saved to your own personal account. 13 Is the App Free? Yes, our app is 100% to patients of Clinical Diagnostic Laboratories. 14 Will This App Tell Me What is Wrong With Me? No. The app does not tell you what is wrong with you, and it does not diagnose any health problems. Only a doctor or licensed medical professional can do that. What the app can do is help you understand your lab numbers in a simple way and suggest potential solutions to achieve optimal lab results. It can show you trends, explain what certain markers usually relate to, and give you general wellness ideas. Think of it like a friendly guide that helps you make sense of your information — not a doctor and not a replacement for medical care. 15 Do I need to schedule an appointment if I purchase the test online? Yes — once you place your order, you'll be prompted to schedule an appointment at one of our laboratory locations. Walk-ins are not permitted for prepaid panels to ensure proper time is set aside for your visit. 16 Will I receive a kit in the mail? No — there is no kit mailed to your home. All testing is performed in our certified laboratory. After purchasing your panel, you'll simply come in for your scheduled blood draw. 17 Do I need to bring anything to my appointment? Just bring a valid photo ID and your email confirmation. There’s no insurance information needed — we’ve already got you in the system. 18 Do I need a doctor’s referral to order a test? Not at all. Our panels are available without a referral, prescription, or insurance. That’s part of what makes this process simple and accessible. 19 How will I receive my results? Results are delivered securely via email in PDF format within 2–5 business days. You’ll be notified as soon as they’re ready. 20 Can I use my HSA or FSA card? Yes — many patients successfully use HSA/FSA cards at checkout. Be sure to check with your plan provider for eligibility. 21 Can I get reimbursed by my insurance? Yes — depending on your insurance policy, you may be eligible for reimbursement by submitting your receipt directly to your provider. However, reimbursement is not guaranteed. Some insurance plans do not cover specific tests or may require additional documentation before testing. We strongly recommend contacting your insurance provider in advance to understand your options, if you wish to be reimbursed. 22 Is there a cancellation fee? Yes — if you cancel your order after purchasing online, a small cancellation fee of 3.4% will be applied to cover non-refundable transaction processing costs. 23 Are you Available for Walk-Ins or Do I Need to Schedule an Appointment? You are not required to schedule an appointment at our facility. We are available for walk-ins during the weekdays during our standard operating hours. However, we do recommend patients schedule appointments ahead of time, contact us via our email form, or call in advance to verify the availability of a Phlebotomist (if bloodwork is required). 24 How Long Does it Take to Receive my Lab Results? The turnaround time of a test varies depending on the test(s) being administered. Typically, a test will take around 24-72 hours. We recommend contacting us ahead of time for more details based on the specific test being administered. 25 I received my results but I'm having trouble opening them Results sent directly to your email will typically be password protected for your security. Passwords will be the Date of Birth of the patient in the following order: (Year/Month/Day). For example, if you're Date of Birth is January 31, 1980 your password will be the following: [1980/01/31] 26 How Will My Results be Delivered? If you provided a doctor's order/referral your results will be sent over directly to your referring physician. You can contact your physician directly for the results of your test (if they did not already contact you). If an order was not provided, you will receive your results via email. Your results will be delivered as a password protected PDF file. 27 How Long Does it Take to Receive COVID test results? The standard turnaround time for PCR-COVID test results is 24 hours. 28 What types of tests do you offer? We offer a wide variety of medical tests including, but not limited to, H.Pylori, Drug screenings, STD testing, COVID, FLU, standard blood panels, and far more. Please contact us for more information. 29 Are Children Permitted to Take a COVID test? Yes, children can take the PCR-Covid test. The cost of the test is the same for children. 30 Are there other options besides a Nasal Swab for the PCR-COVID test? The most effective method of testing for the COVID-19 Coronavirus is via a Nasopharyngeal swab. A cheek or throat swab can also be performed at the request of a physician; however, either of these methods can be inaccurate and may result in an inconclusive lab result. 31 What is the Difference Between a Rapid Test and a PCR test? The Rapid test (also known as the Antigen test) offers a fast turnaround time but is best used on patients showing symptoms. However, the rapid test results tend to be inaccurate when compared to the RT-PCR test. One can expect the results of a Rapid Test within 15 minutes. The RT-PCR (Polymerase Chain Reaction) test is considered the “Golden Standard” with regards to COVID tests. The PCR test is considered the more accurate version when testing for the COVID-19 virus. 32 Do I Need to Pick Up my Results in Person? While you may pick up results in person, the delivered lab results will be sent to your physician directly either through their portal or via fax. If an order was not provided, results will be sent to the email address provided when you schedule an appointment. 33 How do I Access my lab Results? If you came with a doctor’s order, Clinical Diagnostic Laboratories (CDL) will fax your lab results to your doctor’s office. We will also try to email results in a timely manner. However, if you do not receive your results after the given time frame, please follow up with CDL by emailing us at info@clinicaldiagnosticlab.com or call us at 703-430-1111. The email will be from labreport@clinicaldiagnosticlab.com*. Your date of birth in the format ‘YYYYMMDD’ is your password to be used to open this report. *Note: Always check your spam/junk mail if you have not received your results in your standard inbox! **The easiest method of finding your results is to type the email address “labreport@clinicaldiagnosticlab.com” in your email’s search bar as results are often difficult to find when sent to the spam/junk folder.
- Erythrocyte Sedimentation Rate (ESR)
Ordering information regarding a Erythrocyte Sedimentation Rate test for Clinical Diagnostic Laboratories. Erythrocyte Sedimentation Rate (ESR) Ordering Recommendation Methodology The ESR test measures the rate at which red blood cells (erythrocytes) settle at the bottom of a test tube over a period of one hour. Inflammation causes red blood cells to clump together, making them heavier and causing them to fall more quickly1. The distance the red blood cells fall is measured and reported as the ESR. Performed Mon-Sat Reported Within 24 hours New York DOH Approval Status This test is New York DOH approved. Specimen Required Patient Preparation: Collect: Purple top tube Specimen Preparation: Allow serum tube to clot completely at room temperature. Separate serum or plasma from cells ASAP within 30 minutes of collection. Transfer 1 mL serum or plasma to a Standard Transport Tube. (Min: 0.3 mL) Storage/Transport Temperature: Unacceptable Conditions: Remarks: Stability: Reference Interval Components Available Separately Reference Interval By report (reports may vary based on instrumentation) Interpretive Data Note CPT Code 80048 Components Component Test Code Component Chart Name LOINC Aliases
- Cardiolipin Antibody, IgG
Ordering information regarding a Cardiolipin Antibody, IgG test for Clinical Diagnostic Laboratories. Cardiolipin Antibody, IgG Ordering Recommendation Acceptable initial test when antiphospholipid syndrome (APS) is strongly 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-IGG 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 <=14 GPL Negative 15-19 GPL Indeterminate 20-80 GPL Low to Moderately Positive 81 GPL or above High 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 Cardiolipin Antibody IgG Component Test Code 0050901 LOINC 3181-5 Aliases ACA aCL aCL Antibody aCL IgG Anti-Cardiolipin Anticardiolipin Anticardiolipin Antibodies Cardiolip
- Cardiolipin Antibody, IgM
Ordering information regarding a Cardiolipin Antibody, IgM test for Clinical Diagnostic Laboratories. 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
- HPV Assay Test
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

