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- 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
- Tryptase
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
- 404 Error Page | CDL
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- 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
- Rheumatoid Factor (RF)
Ordering information regarding a Rheumatoid Factor (RF) for Clinical Diagnostic Laboratories. Rheumatoid Factor (RF) Ordering Recommendation Aids in the workup of suspected rheumatoid arthritis or undifferentiated inflammatory arthritides. Consider ordering this test in conjunction with Cyclic Citrullinated Peptide (CCP) Antibody, IgG (0055256 ) to increase specificity and sensitivity. Rheumatoid Arthritis Panel (3004055 ) is the preferred test. Mnemonic Methodology Quantitative Immunoturbidimetry Performed Mon-Sat Reported Within 24 hours New York DOH Approval Status This test is New York DOH approved. Specimen Required Patient Preparation: Fasting specimen preferred. Collect: Serum separator tube or plasma separator tube. Also acceptable: Green (lithium heparin), lavender or pink. Specimen Preparation: Allow the specimen to clot completely at room temperature. Transfer 0.5 mL serum or plasma to a Standard Transport Tube. (Min: 0.5 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: 24 hours; Refrigerated: 8 days; Frozen: 3 months (should not be thawed more than once) Reference Interval 0-14 IU/mL Interpretive Data Note CPT Code 86431 Components Component Chart Name Rheumatoid Factor Component Test Code 0050465 LOINC 11572-5 Aliases RA RF Rheumatoid Arthritis Factor
- Schedule An Appointment | Clinical Diagnostic Laboratories
Are you interested in scheduling an appointment for blood testing, COVID, FLU, Allergy testing, or some other medical test? Schedule an appointment with us here. SCHEDULE AN APPOINTMENT Clinical Diagnostic Laboratories is a leading medical laboratory providing a wide variety of tests and services, such as routine blood work, H. Pylori tests, STD testing, drug screening, allergy testing, COVID-19, Flu, and much more. Use our easy scheduling tool below to make an appointment. Also, be sure to check out our FAQs page to address any problems you might have. You may also email us or give us a phone call at (703) 430-1111 .
- Cardiolipin Antibody, IgM
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
- Allergen, Food, Egg Whole
Ordering information regarding a Allergen, Food, Egg Whole test for Clinical Diagnostic Laboratories. Allergen, Food, Egg Whole 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 1-3 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. Specimen Preparation: Separate serum from cells ASAP or within 2 hours of collection. Storage/Transport Temperature: Refrigerated. Unacceptable Conditions: Grossly hemolyzed or lipemic specimens. Remarks: Stability: After separation from cells: Ambient: 48 hours; Refrigerated: 2 weeks; Frozen: 1 year Reference Interval Probability of IgE Mediated Clinical Reaction Reporting Range (reported in kU/L) Class Scoring No significant level detected Less than 0.10 0 0.10 - 0.34 0.35 - 0.70 Clinical relevance undetermined Low 0/1 1 0.71 - 3.50 3.51 - 17.50 Moderate High 2 3 17.51 - 50.00 50.01 - 100.00 Very high Very high 4 5 Greater than 100.00 Very high 6 Interpretive Data 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. Compliance Category: FDA Note Components CPT Code 86003 Component Chart Name Allergen, Food, Egg Whole IgE Component Test Code 0055381 LOINC 7291-8 Aliases ImmunoCAP f245
- ACTH by Immunochemistry
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
- Deamidated Gliadin Peptide (DGP) Antibody, IgA
Ordering information regarding a Deamidated Gliadin Peptide (DGP) Antibody, IgA test for Clinical Diagnostic Laboratories. Deamidated Gliadin Peptide (DGP) Antibody, IgA Ordering Recommendation Acceptable single screening test for celiac disease. IgA testing recommended to identify IgA deficiency. Use IgA test in individuals who are IgA competent. 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, IgA (0097709 ) 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: Plasma. Hemolyzed or severely lipemic specimens. 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 Human recombinant tTG antigen is utilized in this assay CPT Code 86258 Components Component Chart Name Deamidated Gliadin Peptide (DGP) Ab, IgA Component Test Code 0051357 LOINC 63453-5 Aliases Celiac Disease Antibodies Coeliac Disease Antib odies Deamidated Gliadin Antibodies (DGP) Deaminated Gliadin Peptide Antibodies DGP DGP Ab DGP IgA

