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Beta-2 Glycoprotein 1 Antibodies, IgG and IgM Ordering Recommendation Acceptable initial test when antiphospholipid syndrome (APS) is strongly suspected. Order with Lupus Anticoagulant Reflexive Panel (0030181 ) and Cardiolipin Antibodies, IgG and IgM (0099344 ). May also be useful in estimating risk of thrombosis and/or pregnancy-related morbidity in patients with systemic lupus erythematosus (SLE). Mnemonic B2GPI PAN 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. (Min: 0.3 mL) 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 Reference Interval Components <=20 SGU B2Glycoprotein 1, IgG Antibody <=20 SMU B2Glycoprotein 1, IgM Antibody Interpretive Data The persistent presence of IgG and/or IgM beta 2 glycoprotein I (B2GPI) antibodies is a laboratory criterion for the diagnosis of antiphospholipid syndrome (APS). Persistence is defined as moderate or high levels of IgG and/or IgM B2GPI antibodies detected in two or more specimens drawn at least 12 weeks apart (J Throm Haemost. 2006;4:295-306). B2GPI results greater than 20 SGU (IgG) and/or SMU (IgM) are considered positive based on the cutoff values established for this test. International reference materials and consensus units for anti-B2GPI antibodies have not been established (Clin Chim Acta. 2012;413(1-2):358-60; Arthritis Rheum. 2012;64(1):1-10.); results can be variable between different commercial immunoassays and cannot be compared. Strong clinical correlation is recommended for a diagnosis of APS. Low positive IgG and IgM B2GPI antibody levels should 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 86146 x2 Components Component Chart Name B2Glycoprotein 1, IgG Antibody Component Test Code 0050322 LOINC 44448-9 0050323 B2Glycoprotein 1, IgM Antibody 44449-7 Aliases Anti-B2-Glycoprotein 1 Anti-B2-Glycoprotein I Anti-B2-GP 1 Anti-B2-GP1 Anti-B2-GPI Anti-beta-2 glycoprotein 1 Anti-beta-2 glycoprotein I Apolipoprotein H Apolipoprotein H, APOH B2 Glycoprotein 1 antibodies B2GP Antibodies B2GP1 B2GPI IgG, IgM BECKY Beta 2 GP1 Ab IgG Beta 2 GP1 Ab IgM Beta 2GP1 Ab Beta 2Glycoprotein 1

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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

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

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

HEMOGLOBIN A1C ORDERING RECOMMENDATION

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 ​ ​ ​

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 ​