TY - JOUR
T1 - Performance characteristics of an automated assay for the quantitation of CYFRA 21-1 in human serum
AU - Patel, Jay L.
AU - Erickson, J. Alan
AU - Roberts, William L.
AU - Grenache, David G.
N1 - Generated from Scopus record by KAUST IRTS on 2023-09-20
PY - 2010/12/1
Y1 - 2010/12/1
N2 - Objectives: A fragment of cytokeratin 19, CYFRA 21-1, has been reported to be a sensitive tumor marker for non-small cell lung cancer (NSCLC). We describe analytical performance characteristics of a novel CYFRA 21-1 assay and hypothesize that CYFRA 21-1 complements the clinical sensitivity of carcinoembryonic antigen (CEA) and squamous cell carcinoma antigen (SCCa). Design and methods: Performance characteristics of a CYFRA 21-1 immunochemiluminescent assay included analytical sensitivity, imprecision, linearity, analyte stability, and reference interval determination. Ninety-two pretreatment NSCLC serum samples were tested for CYFRA 21-1, CEA, and SCCa. Sensitivity was determined for each marker individually and in combination, with regard to tumor stage and histology. Results: The analytical sensitivity was 0.01ng/mL. Total imprecision ranged from 4.0 to 6.3% at 4.9 to 28.4ng/mL, respectively. The assay was linear from 0.9 to 71.4ng/mL (slope=0.995, intercept=-0.60, r2=0.999). CYFRA 21-1 was stable for 48h at ambient temperature and 14days at 4°C. The 97.5th percentile of a reference population was 1.9ng/mL. Across disease stage, the sensitivities of CYFRA 21-1, CEA, and SCCa were 17-81%, 30-52%, and 24-39%, respectively. CYFRA 21-1 combined with CEA or SCCa increased sensitivity above that of any single marker. Conclusions: An immunochemiluminescent assay for CYFRA 21-1 had favorable performance characteristics. CYFRA 21-1 was complementary to CEA and SCCa and increased clinical sensitivity in patients with NSCLC. © 2010 The Canadian Society of Clinical Chemists.
AB - Objectives: A fragment of cytokeratin 19, CYFRA 21-1, has been reported to be a sensitive tumor marker for non-small cell lung cancer (NSCLC). We describe analytical performance characteristics of a novel CYFRA 21-1 assay and hypothesize that CYFRA 21-1 complements the clinical sensitivity of carcinoembryonic antigen (CEA) and squamous cell carcinoma antigen (SCCa). Design and methods: Performance characteristics of a CYFRA 21-1 immunochemiluminescent assay included analytical sensitivity, imprecision, linearity, analyte stability, and reference interval determination. Ninety-two pretreatment NSCLC serum samples were tested for CYFRA 21-1, CEA, and SCCa. Sensitivity was determined for each marker individually and in combination, with regard to tumor stage and histology. Results: The analytical sensitivity was 0.01ng/mL. Total imprecision ranged from 4.0 to 6.3% at 4.9 to 28.4ng/mL, respectively. The assay was linear from 0.9 to 71.4ng/mL (slope=0.995, intercept=-0.60, r2=0.999). CYFRA 21-1 was stable for 48h at ambient temperature and 14days at 4°C. The 97.5th percentile of a reference population was 1.9ng/mL. Across disease stage, the sensitivities of CYFRA 21-1, CEA, and SCCa were 17-81%, 30-52%, and 24-39%, respectively. CYFRA 21-1 combined with CEA or SCCa increased sensitivity above that of any single marker. Conclusions: An immunochemiluminescent assay for CYFRA 21-1 had favorable performance characteristics. CYFRA 21-1 was complementary to CEA and SCCa and increased clinical sensitivity in patients with NSCLC. © 2010 The Canadian Society of Clinical Chemists.
UR - https://linkinghub.elsevier.com/retrieve/pii/S0009912010004248
UR - http://www.scopus.com/inward/record.url?scp=78149501151&partnerID=8YFLogxK
U2 - 10.1016/j.clinbiochem.2010.09.014
DO - 10.1016/j.clinbiochem.2010.09.014
M3 - Article
SN - 0009-9120
VL - 43
SP - 1449
EP - 1452
JO - Clinical Biochemistry
JF - Clinical Biochemistry
IS - 18
ER -
