KL-6 (Krebs von den Lungen-6)assay kit is a high-molecular-weight mucin belonging to the MUC1 glycoprotein family, primarily secreted by type II alveolar epithelial cells. Clinical studies have shown that elevated KL-6 levels correlate closely with pulmonary fibrosis, inflammation diagnosis, and disease progression.
KL-6 is a key serum biomarker for respiratory diseases, particularly ILD. Elevated levels are commonly seen in:
These conditions are all associated with alveolar epithelial injury. KL-6 testing offers a non-invasive, repeatable, and quantitative monitoring tool.
In clinical management, KL-6 is valuable for:
(1) Global Market Size (Preliminary Estimate)
① Japan – Largest Market: KL-6 is widely used in Japan for diagnosing and monitoring interstitial lung disease (ILD) and is covered by national health insurance. Annual testing volumes are likely in the hundreds of thousands to over one million.
② Europe & North America: KL-6 is used mainly for research or as an auxiliary diagnostic biomarker. It has not yet been widely adopted as part of routine clinical practice, but the market is in a growth phase.
③ Impact of COVID-19: The pandemic increased global awareness of KL-6, especially in respiratory disease monitoring. Future application scenarios may further expand.
(2) Major Brands & Product Comparison
Brand / Platform | Detection Method | Product Features | QC & Price* |
Fujirebio | CLEIA | High sensitivity,high-throughput | Auto QC; $$$ (High) |
Eisai / EIDIA | ECLIA | Clinical-grade stability | Hospital labs; $$$ |
BioVendor | ELISA / Latex | Simple, low-cost | ~$630 / 96 wells |
MyBioSource / Creative Diagnostics | ELISA | Multi-brand, research use | €500–600 / 96 tests |
Poclight | Homogeneous CLIA | No cold chain, portable, 3-15 min TAT,18-month RT; | Free QC with MOQ reagent purchase |
*Price: $ = low, $$ = medium, $$$ = high
5. Accurate KL-6 Measurement with Chemiluminescence Immunoassay (CLIA)
Compared with ELISA, CLIA offers clear benefits in KL-6 detection.CLIA is a technique that combines immunoreactions with chemiluminescent signal detection, well-suited for highly sensitive quantitative measurement of low-concentration biomarkers like KL-6.
Testing workflow:
Case: A patient with systemic sclerosis presented with a KL-6 level of 1800 U/mL at diagnosis (significantly elevated). After 3 months of immunosuppressive therapy, the level decreased to 950 U/mL, imaging showed reduced fibrotic lesions, and dyspnea symptoms improved.
Insight: KL-6 is not only useful for disease detection, but also for quantifying therapeutic response, providing physicians with evidence to adjust treatment plans.
The Poclight C5000 POCT CLIA analyzer offers several competitive advantages for KL-6 testing:
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