title: Evaluation of a novel point-of-care test kit, ABSOGEN™PCT, in semi-quantitative measurement of procalcitonin in whole blood.
abstract: BACKGROUND
  In response to inflammation, procalcitonin plasma concentrations increase more rapidly than other acute-phase reactants and higher values are associated with severe disease. Procalcitonin measurements assist in determining whether antibiotic therapy should be used. point-of-care testing (POCT) is performed for early decision making about additional testing or therapy. The ABSOGEN™PCT (Bumyoungbio, Inc., Suwon, Korea) is a rapid novel semi-quantitative immunochromatographic PCT assay that analyses whole blood samples. We compared the patient quantitative test results to ABSOGEN™PCT test results.
  
  
  METHODS
  Whole blood was loaded onto an ABSOGEN™PCT cartridge and incubated for 10 minutes. The color intensity of the band of the cartridge was measured using an accompanying device and with the naked eye. The results were graded as negative (<0.1 ng/mL), low (0.1 to <1.0 ng/mL), middle (1.0-2.0 ng/mL), and high (>2.0 ng/mL). A total of 158 specimens with procalcitonin levels measured from 0 to 18.96 ng/mL were used for comparison study.
  
  
  RESULTS
  The concordance rate between ABSOGEN™PCT using the reader and quantitative assay, between ABSOGEN™PCT using naked eyes and quantitative assay, and between ABSOGEN™PCT using the reader and naked eyes for the same category was 83.5% (P=.040), 78.5% (P<.001), and 82.3% (P=.001), respectively. The concordance rates for the ±1 categories were all 100%.
  
  
  CONCLUSIONS
  ABSOGEN™PCT is an accurate assay. It is easy to use, simple, fast, portable. The assay has potential value in clinical applications, especially in emergency care.
authors.affiliation: Department of Laboratory Medicine, College of Medicine, The Catholic University of Korea, Seoul, Korea.
authors.forename: Hi Jeong
authors.initials: HJ
authors.lastname: Kwon
authors.affiliation: Department of Laboratory Medicine, College of Medicine, The Catholic University of Korea, Seoul, Korea.
authors.forename: Jehoon
authors.initials: J
authors.lastname: Lee
authors.affiliation: Department of Laboratory Medicine, College of Medicine, The Catholic University of Korea, Seoul, Korea.
authors.forename: Hae-Il
authors.initials: HI
authors.lastname: Park
authors.affiliation: Department of Laboratory Medicine, College of Medicine, The Catholic University of Korea, Seoul, Korea.|The Seoul St. Mary's Hospital IVD Medical Devices Development Center, Seoul, Korea.
authors.forename: Kyungja
authors.initials: K
authors.lastname: Han
mesh_terms: D000328:Adult; D000368:Aged; D001774:Blood Chemical Analysis / Q000379:methods*; D002116:Calcitonin / Q000097:blood*; D002846:Chromatography, Affinity / Q000295:instrumentation / Q000379:methods; D004867:Equipment Design; D005260:Female; D006801:Humans; D016014:Linear Models; D008297:Male; D008875:Middle Aged; D019095:Point-of-Care Systems; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
chemical_list: D002116:Calcitonin
keywords: immunochromatographic; point-of-care testing; procalcitonin; semi-quantitative