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Ordering information regarding a PTINR test for Clinical Diagnostic Laboratories. Prothrombin Time/International Normalized Ratio (PTINR) Ordering Recommendation Initial test for evaluating bleeding disorders and monitoring oral anticoagulation therapy (warfarin/Coumadin). Methodology Electromagnetic Mechanical Clot Detection Performed Mon-Sat Reported 1-2 days New York DOH Approval Status This test is New York DOH approved. Specimen Required Patient Preparation: Collect: Lt. blue (sodium citrate) Specimen Preparation: Transfer 1 mL platelet-poor plasma to a Standard Transport Tube. (Min: 0.5 mL) Storage/Transport Temperature: CRITICAL FROZEN. Separate specimens must be submitted when multiple tests are ordered. Unacceptable Conditions: Serum. EDTA plasma, clotted or hemolyzed specimens. Remarks: Stability: Ambient: 24 hours; Refrigerated: Unacceptable; Frozen: 2 weeks Reference Interval Components Available Separately Reference Interval International Normalized Ratio Coumadin Therapy: INR: 2.0-3.0 conventional anticoagulation INR: 2.5-3.5 intensive anticoagulation Prothrombin Time 12.0-15.5 seconds Interpretive Data Note Reference intervals established using 3.2 percent sodium citrate. CPT Code 85610 Components Component Test Code Component Chart Name LOINC 0030220 Prothrombin Time 5902-2 0030223 International Normalized Ratio 6301-6 Aliases INR Pro Time Protime Protime, PT/INR PT/International Normalized Ratio

Ordering information regarding a Myeloperoxidase (MPO) Antibody test for Clinical Diagnostic Laboratories. Myeloperoxidase (MPO) Antibody Ordering Recommendation When used in conjunction with other autoantibody tests (ANCA, PR3), may aid in evaluating suspected immune-mediated vasculitis, especially microscopic polyangiitis (MPA). May be useful to monitor MPA disease and/or treatment response. 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 MPO-AB Performed Mon-Sat Methodology Semi-Quantitative Multiplex Bead Assay 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. 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 90% of patients with a P-ANCA pattern by IFA have antibodies specific for MPO. Compliance Category: FDA Note CPT Code 83516 Components Component Chart Name Myeloperoxidase (MPO) Ab, IgG Component Test Code 0050526 LOINC 6969-0 Aliases MPO MPO Ab PR3

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 Basic Metabolic Panel test for Clinical Diagnostic Laboratories. C-Reactive Protein Ordering Recommendation Preferred test to detect acute phase inflammation (eg, autoimmune diseases, connective tissue disease, rheumatoid arthritis, infection, or sepsis). DO NOT ORDER for cardiovascular disease (CVD) risk assessment. Test for CVD risk assessment is C-Reactive Protein, High Sensitivity 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: Collect: Plasma separator tube, or serum separator tube SST 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: Specimens collected in EDTA, citrate, or oxalate. Unacceptable Conditions: Hemolyzed specimens. Remarks: Stability: After separation from cells: Ambient: Calcium and CO2: 4 hours, All others: 24 hours; Refrigerated: 1 week; Frozen: 2 weeks Reference Interval Components Available Separately Reference Interval By report (reports may vary based on instrumentation) Interpretive Data By report (reports may vary based on instrumentation) Note CPT Code 86140 Components Component Test Code Component Chart Name LOINC 0050180 C-Reactive Protein 1988-5 Aliases C- Reactive Protein C- Reactive Protein, S CRP CRP, S CRP, Serum Protein, C-Reactive

Ordering information regarding a T4 Total test for Clinical Diagnostic Laboratories. Thyroxine, Total T4 (Total T4) Ordering Recommendation Preferred test for initial screening and monitoring of thyroid function. 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 green (lithium heparin). Also acceptable: lavender Specimen Preparation: Separate serum or plasma from cells ASAP or within 2 hours of collection. Allow serum specimen to clot completely at room temperature. Storage/Transport Temperature: Refrigerated. Unacceptable Conditions: Grossly hemolyzed specimens. Remarks: Stability: After separation from cells: Ambient: 4 days; Refrigerated: 8 days; Frozen: 1 year Reference Interval Components Available Separately Reference Interval Thyroxine, Total T4 Cord Blood 6.60-17.50 ug/dL 0-3 days 5.37-22.40 ug/dL 4-30 days 5.24-23.20 ug/dL 1-23 months 5.37-16.00 ug/dL 2-6 years 5.26-14.80 ug/dL 7-11 years 5.70-14.10 ug/dL 12-19 years 4.74-14.60 ug/dL 20 years and older 4.50-11.70 ug/dL Interpretive Data Note CPT Code 84436 Components Component Test Code Component Chart Name LOINC 3005980 Thyroxine, Total T4 3026-2 Aliases Syn-Thyroid T4 T4 Serum T4 Total Only Tetraiodothyronine Thyroid Hormone Thyroxine (T4) Total T4

Ordering information regarding a Tissue Transglutaminase (tTG) IgG test for Clinical Diagnostic Laboratories. Tissue Transglutaminase (tTG) IgG Ordering Recommendation Recommended single screening test for IgA-deficient individuals with suspected celiac disease. (IgA testing recommended to identify IgA deficiency.) 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 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: Remove serum from cells ASAP or within 2 hours of collection. Transfer 1 mL serum to a Standard Transport Tube. (Min: 0.5 mL) Storage/Transport Temperature: Refrigerated Unacceptable Conditions: Refrigerated. Remarks: Plasma. Hemolyzed or severely lipemic specimens. Stability: After separation from cells: Ambient: 48 hours; Refrigerated: 2 weeks; Frozen: 1 year Reference Interval 5 U/mL or less 6-9 U/mL Negative Weak Positive 10 U/mL or greater Positive Interpretive Data The tTG IgG assay may aid in the diagnosis of gluten-sensitivity enteropathy (i.e., celiac disease, dermatitis herpetiformis) in tTG IgA negative patients with confirmed IgA deficiency. A negative tTG IgG test alone does not rule out gluten-sensitive enteropathy. Note Human recombinant tTG antigen is utilized in this assay CPT Code 86364 Components Component Chart Name Tissue Transglutaminase (tTG) Ab, IgA Component Test Code 0056009 LOINC 56537-4 Aliases Tissue Transglutaminase Transglu taminase tTG tTG IgG

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

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Ordering information regarding a Thyroid Stimulating Hormone test for Clinical Diagnostic Laboratories. Thyroid Stimulating Hormone (TSH) Ordering Recommendation Preferred test for initial screening and monitoring of thyroid function. 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: Plasma separator tube, or serum separator tube SST Specimen Preparation: Separate serum or plasma from cells ASAP or within 2 hours of collection. Allow serum specimen to clot completely at room temperature. Storage/Transport Temperature: Refrigerated. Unacceptable Conditions: Grossly hemolyzed specimens. Remarks: Stability: After separation from cells: Ambient: Calcium and CO2: 4 hours, All others: 24 hours; Refrigerated: 1 week; Frozen: 2 weeks Reference Interval Components Available Separately Reference Interval Interpretive Data Note CPT Code 84443 Components Component Test Code Component Chart Name LOINC 0070145 Thyroid Stimulating Hormone 3016-3 Aliases Thyrotropin TSH TSH, Pregnancy