Triple Rheumatism Panel Lateral Flow Master Plate
Triple Rheumatism Panel Lateral Flow Master Plate

Triple Rheumatism Panel Lateral Flow Master Plate

Rheumatoid Arthritis (RA) is a chronic erosive autoimmune disease with insidious onset. Disease progression can lead to irreversible bone damage, joint deformity and permanent disability. Clinical joint pain stems from complex causes, with highly overlapping symptoms among rheumatoid arthritis, streptococcus-induced rheumatic fever and reactive arthritis. Single testing of RF, CCP or ASO has limitations including insufficient specificity, missed early diagnosis, and inability to distinguish infectious lesions from autoimmune disorders. 

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RA

Limitations of Single Biomarker Testing, Unable to Support Accurate Differential Diagnosis 



● RF - Rheumatoid Factor

Advantages: Widely adopted in clinical practice; effectively reflects RA disease activity for longitudinal monitoring of disease progression.

Limitations: Low specificity. False positives frequently occur in infectious conditions, elderly populations and patients with other autoimmune diseases. Additionally, seronegative RA exists, leading to high risks of missed diagnosis and misdiagnosis when tested alone.


● ASO - Anti-Streptolysin O

Advantages: Specifically indicates Group A streptococcal infection, differentiating streptococcus-mediated rheumatic fever and reactive arthritis.

Limitations: Only detects infectious triggers; cannot diagnose autoimmune rheumatoid disease or assess risks of articular bone erosion, thus incapable of independent differential diagnosis for rheumatic autoimmune disorders.


● CCP - Anti-Cyclic Citrullinated Peptide Antibody

Advantages: High specificity and sensitivity for RA. It serves as an early diagnostic marker and a sensitive indicator to distinguish erosive vs non-erosive RA.

Limitations: Negative results may appear in mild early-stage RA, precluding full disease exclusion via standalone testing. It cannot identify infectious joint lesions or evaluate disease activity.


RA

Core Clinical Pain Points Addressed by Triple Rheumatism Panel Testing 


The combined RF + ASO + CCP assay is a precise differential diagnostic solution for three prevalent joint disorders: rheumatoid arthritis, rheumatic fever and reactive arthritis. The three biomarkers function complementarily with distinct roles:

✓ Avoid misdiagnosis caused by poor RF specificity; achieve definitive RA diagnosis via high-specificity CCP detection;

✓ Compensate for CCP’s inability to identify infectious arthropathies; differentiate rheumatic fever and reactive arthritis through ASO measurement;

✓ Reduce missed diagnoses from single-biomarker testing; accurately identify seronegative RA and lower the underdiagnosis rate of early RA;

✓ Complete etiological identification, disease typing, activity assessment and prognostic risk prediction in a single test, eliminating repeated testing and improving triage accuracy & laboratory throughput for rheumatic disorders.




Triple Rheumatism Panel Lateral Flow Master Plate 



Targeting diverse clinical challenges in rheumatic immune differential testing, DIA-UP launches the triple biomarker master plate covering RF, ASO and CCP. Optimized for batch consistency, metrological traceability, third-party quality control compatibility and analytical performance, the product meets dual demands of large-scale kit manufacturing for reagent manufacturers and high-volume testing in hospitals at all tiers:





01

Validated over 10 production batches annually with minimal inter-batch variation

DIA-UP BIOTECH

Specialized process calibration for the combined RF/ASO/CCP system minimizes intra-batch and inter-batch deviation. Stability is verified across more than 10 mass-production batches each year, delivering consistent results for repeat testing of challenging specimens and high-throughput runs, with tightly controlled long-term production quality fluctuation.






02

Annual shipment volume reaching 10 million test dosages with fully traceable results

DIA-UP BIOTECH

With an annual output of 10 million test dosages, all test results are traceable to standardized chemiluminescence platforms with complete, compliant metrological documentation, supporting manufacturers’ IVD kit registration and quality control filing.






03

Precise calibration compatible with mainstream QC materials (Bio-Rad, Randox, etc.)

DIA-UP BIOTECH

Custom dedicated calibration schemes enable seamless compatibility with mainstream third-party quality control products including Bio-Rad and Randox. Laboratories can conveniently conduct internal quality control and external quality assessment, drastically cutting manufacturers’ R&D costs for supporting QC reagents.






04

Superior low-concentration detection performance to reduce early missed diagnoses

DIA-UP BIOTECH

Optimized antigen-antibody pairs and immune reaction systems enhance detection capability at low CCP concentration ranges, capturing trace autoantibody signals to significantly reduce missed detection of early RA and occult rheumatic lesions, ideal for large-scale primary screening.






05

Broad linear range covering mild to severe rheumatic specimens

DIA-UP BIOTECH

Extended linear detection intervals for RF, ASO and CCP effectively suppress response bias at high analyte concentrations. Accurate, stable readings are delivered for both low-concentration mild specimens and high-value samples from active severe cases, fully covering the specimen spectrum of all rheumatic autoimmune patients.



Comparative Analysis of Positive & Negative Concordance Rates


                    

Parallel specimen comparison tests were performed separately for RF, ASO and CCP to calculate positive and negative concordance rates, validating result consistency of this triple-biomarker master plate.


✦ RF

Reference range: ≤20IU/m

Triple Rheumatism Panel Lateral Flow Master Plate


Positive & Negative Concordance Rate

Triple Rheumatism Panel Lateral Flow Master Plate


✦ ASO

Reference range: ≤200IU/ml

Triple Rheumatism Panel Lateral Flow Master Plate


Positive & Negative Concordance Rate

Triple Rheumatism Panel Lateral Flow Master Plate


✦ CCP

Reference range: ≤40U/ml

Triple Rheumatism Panel Lateral Flow Master Plate


Positive & Negative Concordance Rate

Triple Rheumatism Panel Lateral Flow Master Plate



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