Knowledge IVD Applications

IVD Applications

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How To Select Primary Plating Media For Pathogen Recovery? Expert Strategy Guide

Learn how diagnostic labs and media manufacturers select primary plating media to optimize fastidious, enteric, and anaerobic pathogen recovery.

What Are The Key Diagnostic Modalities For Identifying Cp-Cre? Compare Naats, Phenotypic & Lateral Flow

Compare CP-CRE diagnostic modalities: molecular NAATs, phenotypic tests, and rapid multiplex lateral flow assays for optimal clinical workflows.

What Are The Kinetic & Clinical Performance Differences Between Crp And Pct? Ivd Insights

Learn how CRP and PCT differ in release kinetics, pathway specificity, and diagnostic utility to optimize your IVD assay design.

How Do Naats Compare To Eias For C. Difficile Detection, And Why Use Multi-Step Algorithms?

Compare NAATs vs. EIAs for C. difficile testing. Discover why multi-step algorithms balance sensitivity and specificity to avoid overdiagnosis.

Why Is Minimizing Turnaround Time Critical For Ivd Assays Targeting Bloodstream Infections? Save Lives & Cut Costs

Explore why rapid IVD turnaround time is critical in bloodstream infections to reduce sepsis mortality, optimize therapy, and cut healthcare costs.

What Key Qa Metrics Should Microbiology Labs Monitor During Analytical Testing? Ensure Diagnostic Accuracy

Learn the essential analytical phase QA metrics for microbiology labs and IVD developers, from positivity rates to qPCR amplification efficiency.

Which Testing Phase Accounts For The Most Lab Errors? Optimize Preanalytical Workflows

Preanalytical errors cause 70% of lab mistakes. Discover how standardizing collection, transport, and processing protects sample quality.

Why Is Quantitative Bkv & Cmv Monitoring Critical In Transplant Diagnostic Assays? Protect Patient Grafts

Discover why quantitative BKV & CMV viral load monitoring is vital for transplant patients to detect reactivation early and prevent organ failure.

For Which Clinical Patient Populations Is The Standardized Inr Assay Valid In Diagnostic Coagulation Monitoring?

Discover when the standardized INR assay is clinically valid (long-term warfarin therapy) and its critical limitations in DOACs and liver disease.

Why Is A Precise Blood-To-Anticoagulant Ratio Critical In Ivd Coagulation Testing? Ensure Accurate Pt & Aptt

Discover how underfilled sodium citrate tubes alter calcium levels and distort PT, aPTT, and fibrinogen results in automated IVD testing.

Why Are Both Immediate And Incubated Mixing Studies Necessary In Aptt Diagnostic Algorithms? Key Diagnostic Guide

Learn why combining immediate and incubated mixing studies is essential to distinguish factor deficiencies from time-dependent aPTT inhibitors.

How Does Emicizumab Impact Aptt-Based Coagulation Assays? Valid Test Formats

Learn how emicizumab interferes with aPTT-based assays and explore reliable alternative test formats like PT, TT, and bovine chromogenic FVIII assays.

What Causes Analytical Discrepancies Between One-Stage & Chromogenic Assays In Ehl Monitoring? Key Root Causes

Learn why EHL factor modifications cause assay discrepancies between one-stage aPTT and chromogenic tests, and how to ensure accurate monitoring.

How Does The Species Source Of Thromboplastin In Pt Reagents Influence Factor Vii Padua Detection?

Learn how rabbit, bovine, and human thromboplastin sources alter PT assay results for Factor VII variants like FVII Padua to prevent misdiagnosis.

How Do Tissue Factor Sources Impact Factor Vii Padua Detection? Avoid Misdiagnosis

Discover how rabbit, human, and bovine thromboplastin raw materials impact Factor VII Padua assay results and prevent diagnostic errors.

How Non-Parallelism In Factor Viii Assays Reveals Inhibitors & How To Correct It

Learn how non-parallelism in Factor VIII assays reveals clotting inhibitors and how to correct results using extended serial dilutions.

How Do Blood-To-Citrate Ratios Affect Clot Assays? High-Hct Citrate Adjustment Guidelines

Discover how blood-to-citrate ratios impact PT/aPTT tests and master the standard formula for citrate adjustments in high-hematocrit samples.

What Diagnostic Assay Formats Evaluate Adamts13 Activity In Ttp? Modern Methods & Workflows

Compare ADAMTS13 assay formats for TTP diagnosis, including FRET, ELISA, and mixing studies to measure enzyme activity and autoantibody inhibitors.

Why Does Leukocyte Contamination Interfere With Pk Deficiency Testing? Standardizing Assay Performance

Learn how leukocyte contamination causes false-negative PK deficiency tests and how technical services standardize assay workflows.

How Does Reticulocytosis Affect Rbc Enzyme Assays? Essential Ivd Kit Design Strategies

Learn how reticulocytosis masks RBC enzyme deficiencies (G6PD, PK, HK) and explore IVD kit design strategies like ratio metrics & pure raw materials.

What Are The Clinical Cross-Reactivity Risks And Limitations Of Hb Bart's Strip Tests? Key Screening Insights

Explore cross-reactivity risks (Hb F, Hb E) and false-negative limitations of Hb Bart's strip tests in alpha-thalassemia screening algorithms.

What Causes False Hb A2 Elevation In Hplc & How To Address It? Diagnostic Guide

Discover the causes of false Hb A2 elevation in cation-exchange HPLC and how labs address interference using CZE and reflex testing.

How Do Cbc Discriminant Indices And Biomarkers Differentiate Thalassemia From Ida? Expert Ivd Guide

Learn how CBC discriminant indices and biochemical markers (ferritin, sTfR, CHr) differentiate thalassemia trait from iron deficiency anemia.

Why Is Mch Preferred Over Mcv In Thalassemia Screening? Ensure Sample Stability & Accuracy

Learn why MCH is superior to MCV in automated thalassemia screening due to pre-analytical EDTA stability and reduced false negatives.

What Are Optimal Sample Handling And Storage Conditions For Whole Blood Specimens? Key Guidelines For Assay Accuracy

Learn optimal 4°C handling for whole blood specimens: a 5-day window for Hb variant analysis vs. 48 hours for accurate RBC indexing.

Why Use Two Methods For Screening Hemoglobin Variants? Prevent Misdiagnosis

Learn why clinical guidelines require two distinct analytical methods (HPLC & electrophoresis) to accurately screen hemoglobin variants.

How Does Hb D-Punjab With Beta-Thalassemia Impact Hb A2 On Hplc? Diagnostic Challenges & Solutions

Learn how Hb D-Punjab co-inheritance distorts HPLC Hb A2 baseline readings and explore CE and molecular testing strategies for accurate diagnosis.

What Pre-Analytical & Analytical Considerations Enable Reliable Hb Constant Spring Detection? Key Guidelines

Discover essential pre-analytical and analytical protocols to reliably detect labile Hb Constant Spring variants and prevent false negatives.

How Does Co-Inheritance Of Alpha-Thalassemia Impact Beta-Variant Quantification? Diagnostic Guide

Learn how alpha-thalassemia co-inheritance suppresses beta-variant percentages (Hb S/C/E) and key strategies to avoid diagnostic misclassification.

Why Are Molecular Assays Needed For Alpha-Thalassemia Minor Diagnosis? Uncover Hidden Dna Mutations

Learn why routine Hb assays miss alpha-thalassemia minor and how molecular DNA testing accurately detects deletions and cis/trans mutations.

What Are The Key Non-Infectious Rbc Inclusion Bodies In Ivd Blood Smear Testing & Their Biochemical Compositions?

Discover the 5 key non-infectious RBC inclusion bodies in IVD blood smear testing, their biochemical compositions, and optimal staining techniques.

What Causes Edta-Induced Pseudothrombocytopenia? Mechanisms & Solutions For Labs

Discover the causes of EDTA-induced pseudothrombocytopenia and false WBC counts, plus actionable lab protocols and IVD strategies to resolve them.

How Do Ferritin, Stfr, And Hepcidin Assays Differentiate Ida From Acd? Master Diagnostic Algorithms

Learn how combining ferritin, sTfR, and hepcidin assays in diagnostic algorithms accurately differentiates IDA, ACD, and mixed anemias.

Why Are Flow Cytometry And Ihc Preferred Over Light Microscopy In Aml? Diagnostic Accuracy Revealed

Discover why flow cytometry and IHC surpass light microscopy in AML diagnosis by delivering objective antigen profiling and precise blast quantification.

What Role Do Immunophenotyping Reagents Play In Plasma Cell Disorders? Unlock Precise Diagnostic Cutoffs

Discover how diagnostic immunophenotyping reagents overcome morphology limits to deliver accurate cell counts and define plasma cell thresholds.

Why Are Specialized Diagnostic Immunophenotyping Assays Critical For Correctly Identifying Hairy Cell Leukemia (Hcl)?

Automated analyzers misidentify Hairy Cell Leukemia as normal monocytes. Learn how immunophenotyping ensures accurate HCL diagnosis.

How Do Flow Cytometry Reagents Resolve All Diagnostic Ambiguities? Master Lineage Mapping & Panel Design

Discover how flow cytometry reagents & immunophenotyping distinguish ALL blasts from AML, hematogones, and blastoid lymphomas.

How Do Molecular Diagnostic Assays Resolve Diagnostic Ambiguities Between Clonal Eosinophilia And Reactive Eosinophilia? Key Guide

Learn how targeted molecular assays (FISH/RT-PCR) detect gene fusions like PDGFRA and CBFB-MYH11 to differentiate clonal from reactive eosinophilia.

How Are Mpo And Nse Assays Used To Differentiate Aml Subtypes? A Complete Diagnostic Guide

Discover how MPO and NSE cytochemical assays enable rapid AML subtyping, distinguishing APL from monocytic variants in clinical workflows.

What Distinct Morphological And Cytochemical Features Characterize Acute Promyelocytic Leukemia (Apl)? Diagnostic Guide

Explore the morphological and cytochemical hallmarks of APL, and learn why rapid PML-RARA molecular workflows are vital to avert fatal bleeding.

How Do Congenital Neutrophil Anomalies Differ Morphologically From Acquired States? Diagnostic Guide

Learn key morphologic differences between congenital neutrophil anomalies (PHA, CHS, May-Hegglin) and acquired reactive states for IVD accuracy.

What Defines Toxic Neutrophils? Differentiating Reactive Changes From Intracellular Pathogens

Explore toxic neutrophil hallmarks like Döhle bodies and vacuolation, and learn how to differentiate them from intracellular pathogens.

How Is Propidium Iodide Utilized As An Ivd Reagent Component In Cell Analysis And Flow Cytometry Assays? Guide

Explore how propidium iodide (PI) powers live/dead gating, cell viability, and apoptosis assays in IVD reagents and flow cytometry workflows.

How Does Edta-Induced Pseudothrombocytopenia Cause Spurious Platelet Counts & How Do Reagents Resolve It?

Discover how EDTA triggers platelet clumping leading to spurious cell counts, and explore specialized reagents to ensure accurate diagnostic results.

What Is The Clinical Significance Of Determining Leukocyte Viability On Automated Cell Counters? Reagent Insights

Learn the clinical significance of leukocyte viability in hematology and how membrane-impermeable dyes like PI are formulated for cell counters.

How Are Rbc Indices Calculated In Automated Ivd Hematology? Diagnostic Value Explained

Learn how RBC indices (MCV, MCH, MCHC, RDW) are derived in automated IVD hematology and their clinical value in diagnosing anemias.

How Do Companion Diagnostic (Cdx) Devices Support Targeted Oncology Drug Development And Clinical Patient Stratification?

Learn how companion diagnostics (CDx) accelerate oncology drug development, optimize clinical patient stratification, and enhance trial efficiency.

Why Combine Methylation & Mutation Panels For Crc Mrd? Boost Sensitivity & Catch Early Recurrence

Learn why combining methylation markers with mutation panels enhances CRC MRD assays by overcoming clonal evolution and improving early detection.

How Do Liquid Biopsy Assays Overcome Tissue Biopsy Limitations? Precision Oncology Insights

Explore how liquid biopsy complements tissue biopsy through ctDNA tracking, enabling real-time monitoring and heterogeneity mapping.

What Is The Appropriate Clinical Indication For T-Cell Clonality Testing? Optimization Insights

Discover when T-cell clonality testing is indicated and how clinical needs drive multiplex primer design, controls, and assay optimization.

What Are The Clinical Applications And Preanalytical Challenges In Liquid Biopsy Assays For Ctcs & Ctdna?

Explore clinical applications of CTCs and ctDNA in liquid biopsy and key preanalytical standardization strategies for diagnostic assay development.

What Biological Characteristics Justify Using Ihc For Alk-Positive Alcl? Key Biological Drivers

Discover why complete absence of normal tissue ALK protein makes IHC a rapid, accurate frontline screening tool for ALK-positive ALCL.

Why Is Quantitative Rt-Pcr Preferred Over Fish For Mrd Monitoring In Bcr-Abl1 Positive Leukemia?

Discover why quantitative RT-PCR outperforms FISH in BCR-ABL1 MRD monitoring with superior sensitivity, broad dynamic range, and MMR quantification.

What Diagnostic Advantages Does Integrating Rna Sequencing Alongside Dna Sequencing Provide? Unlock Actionable Targets

Learn how integrating RNA-seq with DNA sequencing uncovers gene fusions, eliminates diagnostic blind spots, and expands actionable oncology targets.

How Do Basket And Umbrella Trials Address Off-Label Ngs Challenges? Precision Assay Strategy

Explore how basket and umbrella trial designs resolve off-label targeted therapy challenges and guide effective NGS biomarker panel strategies.

What Vus Challenges Arise In Ngs Solid Tumor Panels, And How To Mitigate Them? Lab Strategies

Learn how diagnostic labs resolve VUS challenges in expanded NGS solid tumor panels using curated databases and bioinformatic workflows.

How Does Identifying A Maternal Ube3A Variant Affect Angelman Syndrome Risk And Diagnostic Assay Requirements?

Learn how maternal UBE3A variants drive a 50% Angelman syndrome recurrence risk and why multi-modal diagnostic assays are essential.

What Is The Clinical Significance Of Assessing Msi Status Within Ngs Solid Tumor Panels? Guide Precise Therapy

Learn how MSI testing in NGS panels guides immunotherapy, prevents ineffective 5-FU chemotherapy, and enhances molecular lab decision-making.

Why Use Braf V600E Allele-Specific Pcr In Msi-H Reflex Testing? Streamline Triage

Learn how allele-specific PCR for BRAF V600E differentiates sporadic MSI-H tumors from Lynch syndrome, saving costs and streamlining workflows.

How Do Multiplex Pcr-Based Msi Testing And Ihc Complement Each Other In Lynch Syndrome Screening? Ivd Guide

Discover how multiplex PCR and IHC work together in Lynch syndrome screening, plus key technical and regulatory insights for IVD developers.

Why Dna Assays Over Functional Apcr For Anticoagulated Patients? Ivd Growth Strategy

Learn why molecular APCR assays outperform functional tests during anticoagulation therapy and how IVD manufacturers can tap into this critical market.

What Complementary Molecular Testing Strategies Maximize Men1 Variant Detection? Combine Sequencing With Mlpa

Maximize MEN1 variant detection up to 95% by combining full-gene sequencing with MLPA copy-number variant analysis.

Why Are Multi-Gene Mps Panels Replacing Single-Gene Sequencing In Marfan Syndrome? Boost Diagnostic Accuracy

Learn why multi-gene MPS panels outperform single-gene FBN1 sequencing, overcoming diagnostic blind spots and improving aortopathy diagnosis.

How Should Molecular Diagnostic Laboratories Design A Men1 Testing Workflow For Maximum Yield?

Discover how combining full-gene sequencing and MLPA CNV analysis maximizes MEN1 gene variant detection up to 95% in clinical laboratories.

Why Is A Multi-Tiered Testing Strategy Recommended For Gjb2/Gjb6 Hearing Loss? Optimize Yield & Efficiency

Discover how a multi-tiered molecular testing strategy for GJB2/GJB6 genes optimizes diagnostic yield and reduces costs for nonsyndromic hearing loss.

How Is Capillary Electrophoresis Applied In Mcc Screening? Ensure Prenatal Diagnostic Accuracy

Learn how capillary electrophoresis and STR fragment analysis detect maternal cell contamination (MCC) to ensure accurate prenatal genetic testing.

What Are The Workflow And Design Differences Between Direct Molecular Amplification And Maldi-Tof In Ivd?

Explore key workflow, reagent, and design differences between direct molecular amplification and MALDI-TOF mass spectrometry for IVD bacterial ID.

How Does The 'Test Once, Analyze Multiple Times' Paradigm Influence Genomic Dna Sample Preservation And Re-Analysis Strategies?

Discover how the 'test once, analyze multiple times' genomic paradigm drives ambient storage, DNA stabilization, and long-term re-analysis strategies.

Why Is Integrating Transcriptomics And Epigenomics Essential For Resolving Vus? Move From Variant To Diagnosis

Learn how integrating transcriptomics and epigenomics with sequencing resolves VUS by providing functional proof for clinical diagnostic confidence.

How Do Ces And Cgs Differ In Acmg Secondary Variant Reporting? Key Scope & Technical Differences

Discover how cES and cGS differ in ACMG secondary variant reporting, from non-coding pathogenic variant detection to CNV resolution and data burden.

What Are The Clinical Benefits & Technical Requirements Of Ultra-Rapid Ces/Cgs In Nicus? Key Guide

Explore the clinical benefits, diagnostic yields, and technical requirements of implementing ultra-rapid cES/cGS for neonatal diagnostics.

How Does Sequencing Depth Impact The Detection Limit Of Genetic Mosaicism In Clinical Genomic Diagnostic Assays? (Guide)

Learn how sequencing depth, background noise, and UMI error correction define the limit of detection for genetic mosaicism in clinical diagnostic assays.

What Key Qc Metrics Should Diagnostic Labs Monitor During Clinical Ngs Validation? Master Outlier Evaluation

Learn the 4 key NGS QC metrics—Alignment, Duplication, Ti/Tv, Het/Hom—and how to evaluate outliers to ensure clinical diagnostic accuracy.

What Are The Core Stages Of A Clinical Bioinformatics Pipeline? Master Ngs Variant Analysis

Explore the 3 key stages of a clinical bioinformatics pipeline—primary, secondary, and tertiary analysis—to optimize NGS variant identification.

Why Is Effective Red Blood Cell Removal Crucial During Genomic Dna Extraction? Ensure Reliable Pcr Diagnostics

Learn why RBC removal is critical in genomic DNA extraction for PCR. Prevent heme inhibition and ensure accurate molecular diagnostic results.

How Does Snv Detection Via Ngs Drive Oncology Assays? Key Ivd Raw Material Metrics

Discover how NGS-driven SNV detection powers oncology IVD assays and learn the essential raw material metrics for library prep accuracy.

What Major Biochemical Investigations Are Required For Screening Congenital Disorders Of Glycosylation (Cdg)?

Learn how CDT, N-glycan, and O-glycan profiling screen for CDG, and how high-purity IVD raw materials drive reliable LC-MS/MS assay performance.

Why Is C26:0-Lysopc Superior To Plasma Vlcfas For X-Ald Newborn Screening?

Learn why C26:0-lysoPC outperforms plasma VLCFAs in X-ALD newborn screening by eliminating female carrier blind spots and dietary false positives.

How Should Clinical Labs Address Cact And Cpt-2 Deficiency Overlap In Screening Workflows?

Learn how clinical diagnostic labs resolve the biochemical overlap of CACT and CPT-2 deficiencies using a 2-tiered screening & reflex workflow.

What Is The Clinical Utility Of Ffn Immunoassay Testing? High Npv & Preterm Labor Management

Explore the clinical utility of fFN immunoassay testing. Learn how high NPV safely rules out preterm labor and avoids unnecessary intervention.

How Does Pg Function As An Ivd Biomarker For Fetal Lung Maturity Vs. L/S Ratio & Lbc? Explore Key Advantages.

Compare PG, L/S ratio, and LBC for fetal lung maturity. Discover why PG provides unmatched specificity and contamination resistance for IVD assays.

What Are The Performance Metrics Of Full Vs. Serum-Integrated Down Syndrome Screening? Comparing Analytes & Fpr

Compare full vs. serum-integrated Down syndrome screening: learn how 1% vs 3% false-positive rates and key analytes impact diagnostic accuracy.

How Does Maternal Body Weight Affect Prenatal Serum Biomarkers, And How Should Algorithms Adjust?

Learn how maternal weight dilutes prenatal biomarkers (AFP, hCG, PAPP-A) and how to implement weight-adjusted MoM clinical algorithms.

What Are The Key Biomarker Patterns In First-Trimester Serum Screening For Down Syndrome? Key Assay Insights

Learn how PAPP-A and free β-hCG levels shift in first-trimester Down syndrome screening and why 12–13 week timing optimizes assay performance.

Which Maternal Serum Biomarkers Are In Second-Trimester Screens? Down Syndrome Vs. Trisomy 18 Profiles

Learn about the 4 second-trimester screening biomarkers (AFP, hCG, uE3, InhA) and how their MoM profiles differ in Down syndrome and Trisomy 18.

What Is The Clinical Significance Of Measuring Both Afp And Ache For Ontd Confirmation? Prevent False Positives

Discover how combining AFP and AChE in amniotic fluid assays eliminates false positives from blood contamination for precise oNTD diagnosis.

Which Biomarker Combination Is Required For Second-Trimester Quadruple Screening For Down Syndrome? Analyte Guide

Explore the 4 key markers (AFP, uE3, hCG, Inhibin A) in 2nd-trimester Down syndrome screening and their characteristic MoM level shifts.

What Is The Clinical Utility Of Sflt-1 & Plgf Immunoassays For Preeclampsia? Key Insights For Ivd Developers

Explore the diagnostic utility of sFlt-1 & PlGF immunoassays in preeclampsia risk assessment, from early screening to short-term rule-out triage.

How Do Fsh, Lh & Testosterone Panels Differentiate Primary Vs Secondary Hypogonadism?

Learn how FSH, LH, and testosterone immunoassay panels use negative feedback to differentiate primary from secondary hypogonadism in male infertility.

What Assay Standards & Reference Intervals Are Needed For Gender-Affirming Hormone Therapy? Ensure Diagnostic Safety

Explore essential assay performance standards and reference interval strategies for clinical labs monitoring gender-affirming hormone therapy.

How Are Lh, Fsh, And Testosterone Panels Used To Differentiate Primary From Secondary Hypogonadism?

Learn how LH, FSH, and testosterone immunoassay panels differentiate primary and secondary hypogonadism via HPG axis negative feedback logic.

What Is The Clinical Utility Of Amh & Inhibin B Immunoassays In Evaluating Sertoli Cell Function & Testicular Health?

Explore the clinical utility of AMH and Inhibin B immunoassays in evaluating Sertoli cell function, cryptorchidism, and testicular integrity.

How Does Shbg Elevation Affect Testosterone Assay Interpretation, And When Is Free T Needed?

Learn how SHBG elevation impacts total testosterone assay interpretation and when free testosterone testing is required in hypogonadism diagnostics.

How Does Estriol (E3) Biosynthesis Justify Its Role In Maternal Screening & Down Syndrome Ivd Assays?

Explore why uE3 biosynthesis is essential for Down syndrome screening and key immunoassay design strategies for IVD developers.

How Do Tsh And T4 Distinguish Primary From Secondary Hypothyroidism? Diagnostic & Raw Material Kit Guide

Learn how TSH/T4 lab results distinguish primary vs. secondary hypothyroidism and discover essential raw materials for thyroid IVD kit design.

Why Is Anti-Tg Testing Integrated Alongside Anti-Tpo In Thyroid Panels? Key Insights For Ivd Labs

Learn why anti-Tg is combined with anti-TPO in thyroid panels to close autoimmune diagnostic gaps and prevent Tg tumor marker interference.

How Can Free Alpha-Subunit To Tsh Ratio Differentiate Tsh Adenoma From Rth? Key Diagnostic Guide

Discover how measuring the free alpha-subunit to TSH ratio accurately differentiates TSH-secreting pituitary adenomas from RTH in immunoassays.

What Physiological Kinetics Govern Serum Tsh Levels? Optimize Ivd Testing Schedules

Learn how physiological kinetics govern TSH delay post-thyroid replacement and why a 4–6 week window is vital for accurate IVD assay scheduling.

How Do Biomarker Profiles Differ In Thyroiditis Vs Graves Disease? The Role Of Trab

Learn key biomarker differences between destructive thyroiditis and Graves disease, and why TRAb assays are essential for diagnostic precision.

Why Is Serum Thyroglobulin (Tg) A Critical Biomarker In Thyroid Panels? Key Insights For Ivd Kit Development

Explore why serum thyroglobulin (Tg) is a vital biomarker for thyroid status & iodine deficiency, and how to optimize Tg IVD immunoassay panels.