Analytical evaluation of Diazyme procalcitonin (PCT) latex-enhanced immunoturbidimetric assay on Beckman Coulter AU5800
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Mariella Dipalo
Abstract
Background: This study was aimed to evaluate the analytical performance of the novel Diazyme procalcitonin (PCT) immunoturbidimetric assay on Beckman Coulter AU5800.
Methods: Diazyme PCT is a latex-enhanced immunoturbidimetric assay, developed for use on laboratory instrumentations with capability of reading absorbance at 600 nm. This analytical evaluation included the assessment of limit of blank (LOB), limit of detection (LOD), functional sensitivity, imprecision, linearity, carryover, and method comparison between Diazyme PCT and Kryptor PCT on 129 routine serum inpatient samples.
Results: The LOB, LOD, and functional sensitivity of Diazyme PCT were 0.16, 0.26, and 0.28 ng/mL, respectively. The intra- and inter-assay imprecision of Diazyme PCT was between 2.9% and 7.8%. The linearity was excellent in the range of PCT values between 0.16 and 56 ng/mL, and the carryover was negligible (0.02%). A highly significant agreement was found between Kryptor PCT and Diazyme PCT in a range of concentrations between 0.16 and 111 ng/mL (Diazyme PCT=1.10×Kryptor PCT–0.89; r=0.960; p<0.001). The mean bias was 0.48 ng/mL (95% CI, –0.58 to 1.54 ng/mL). The strength of agreement between Kryptor PCT and Diazyme PCT was between 85% and 96% at 0.50, 2.0, and 10 ng/mL cutoffs.
Conclusions: Diazyme PCT appears to be a reliable assay for diagnosis and management of critical care patients susceptible to severe bacterial infections.
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©2015 by De Gruyter
Articles in the same Issue
- Frontmatter
- Editorials
- “Personalized” sepsis care with the help of specific biomarker levels on admission and during follow up: are we there yet?
- Procalcitonin-guided antibiotic therapy: a potentially effective and efficient strategy
- Review
- The prognostic blood biomarker proadrenomedullin for outcome prediction in patients with chronic obstructive pulmonary disease (COPD): a qualitative clinical review
- General Clinical Chemistry and Laboratory Medicine
- Diagnostic testing for a high-grade inflammation: parameter dynamics and novel markers
- Serial changes in serum procalcitonin, interleukin 6, and C-reactive protein levels according to non-specific surgical stimulation
- Utility of procalcitonin, C-reactive protein and white blood cells alone and in combination for the prediction of clinical outcomes in community-acquired pneumonia
- Presepsin as a potential marker for bacterial infection relapse in critical care patients. A preliminary study
- Diagnosis and evaluation of severity of sepsis via the use of biomarkers and profiles of 13 cytokines: a multiplex analysis
- Economic evaluation of procalcitonin-guided antibiotic therapy in acute respiratory infections: a US health system perspective
- Analytical evaluation of Diazyme procalcitonin (PCT) latex-enhanced immunoturbidimetric assay on Beckman Coulter AU5800
- Calprotectin and lactoferrin in the cerebrospinal fluid; biomarkers utilisable for differential diagnostics of bacterial and aseptic meningitis?
- Cancer Diagnostics
- Increased level of circulating U2 small nuclear RNA fragments indicates metastasis in melanoma patients
- Cardiovascular Diseases
- Comparison between admission natriuretic peptides, NGAL and sST2 testing for the prediction of worsening renal function in patients with acutely decompensated heart failure
- Diabetes
- Weight loss reduces serum monocyte chemoattractant protein-1 concentrations in association with improvements in renal injury in obese men with metabolic syndrome
- Letters to the Editors
- Ranking prestige of medical and laboratory technology journals
- Expression of CD64 on neutrophils (CD64 index): diagnostic accuracy of CD64 index to predict sepsis in critically ill patients
- Measurement of apolipoprotein M in sepsis-related deaths
- The stability of select biomarkers in frozen plasma over time: an evaluation of a low-volume sample analyzer
- Is the new Beckman AccuTnI+3 assay capable of producing false-positive troponin I results?
- Spectrum of red cell abnormalities in undiagnosed hemolytic anemias and methemoglobinemias: a single center experience
- Correlation of methadone concentrations in plasma and saliva collected with and without stimulation in pain management patients
- Higher alkaline phosphatase was associated with the short-term adverse outcomes of peritoneal dialysis-related peritonitis
- The use of a rapid fluorogenic neuraminidase assay to differentiate acute Streptococcus pneumoniae-associated hemolytic uremic syndrome (HUS) from other forms of HUS
- Congress Abstracts
- 3rd EFLM-BD European Conference on Preanalytical Phase
Articles in the same Issue
- Frontmatter
- Editorials
- “Personalized” sepsis care with the help of specific biomarker levels on admission and during follow up: are we there yet?
- Procalcitonin-guided antibiotic therapy: a potentially effective and efficient strategy
- Review
- The prognostic blood biomarker proadrenomedullin for outcome prediction in patients with chronic obstructive pulmonary disease (COPD): a qualitative clinical review
- General Clinical Chemistry and Laboratory Medicine
- Diagnostic testing for a high-grade inflammation: parameter dynamics and novel markers
- Serial changes in serum procalcitonin, interleukin 6, and C-reactive protein levels according to non-specific surgical stimulation
- Utility of procalcitonin, C-reactive protein and white blood cells alone and in combination for the prediction of clinical outcomes in community-acquired pneumonia
- Presepsin as a potential marker for bacterial infection relapse in critical care patients. A preliminary study
- Diagnosis and evaluation of severity of sepsis via the use of biomarkers and profiles of 13 cytokines: a multiplex analysis
- Economic evaluation of procalcitonin-guided antibiotic therapy in acute respiratory infections: a US health system perspective
- Analytical evaluation of Diazyme procalcitonin (PCT) latex-enhanced immunoturbidimetric assay on Beckman Coulter AU5800
- Calprotectin and lactoferrin in the cerebrospinal fluid; biomarkers utilisable for differential diagnostics of bacterial and aseptic meningitis?
- Cancer Diagnostics
- Increased level of circulating U2 small nuclear RNA fragments indicates metastasis in melanoma patients
- Cardiovascular Diseases
- Comparison between admission natriuretic peptides, NGAL and sST2 testing for the prediction of worsening renal function in patients with acutely decompensated heart failure
- Diabetes
- Weight loss reduces serum monocyte chemoattractant protein-1 concentrations in association with improvements in renal injury in obese men with metabolic syndrome
- Letters to the Editors
- Ranking prestige of medical and laboratory technology journals
- Expression of CD64 on neutrophils (CD64 index): diagnostic accuracy of CD64 index to predict sepsis in critically ill patients
- Measurement of apolipoprotein M in sepsis-related deaths
- The stability of select biomarkers in frozen plasma over time: an evaluation of a low-volume sample analyzer
- Is the new Beckman AccuTnI+3 assay capable of producing false-positive troponin I results?
- Spectrum of red cell abnormalities in undiagnosed hemolytic anemias and methemoglobinemias: a single center experience
- Correlation of methadone concentrations in plasma and saliva collected with and without stimulation in pain management patients
- Higher alkaline phosphatase was associated with the short-term adverse outcomes of peritoneal dialysis-related peritonitis
- The use of a rapid fluorogenic neuraminidase assay to differentiate acute Streptococcus pneumoniae-associated hemolytic uremic syndrome (HUS) from other forms of HUS
- Congress Abstracts
- 3rd EFLM-BD European Conference on Preanalytical Phase
