Evaluation of a New Automated Routine Measurement for Serum Adjusted Ionized Calcium (at pH 7.4) in Patients Suspected of Calcium Metabolic Disease.

BACKGROUND: Total calcium is a less accurate test in predicting ionized calcium (Ca2+) in patients suspected of calcium metabolic disease. Nevertheless, total calcium continues to be used as routine measurement instead of adjusted Ca2+ (at pH 7.4). In the current study we evaluate a new multichannel instrument, the ISE Module E1200 for adjusted Ca2+ (at pH 7.4), containing three different ion-selective electrode (ISE) units. METHODS: Serum from 1350 patients was compared to the ABL835 flex and KoneLab. Total calcium was also evaluated on the Dimension Vista 1500 system. Correlations between instruments were assessed by Deming regression and degree of agreement by Cohen's kappa (κ). RESULTS: Analytical imprecisions for the three ISE units for adjusted Ca2+ (at pH 7.4) was between 0.36% and 2.52%, and for pH between 0.32% and 3.24%. Results were comparable for each ISE unit (r = 0.797-0.917; all P < 0.0001) and in high-throughput settings (r = 0.871; P < 0.0001). The degree of agreement between instruments was moderate to good (κ = 0.52-0.77). In contrast, there was a very poor agreement (κ = -0.14) for total calcium with discrepancy in 53.4% of the samples. CONCLUSIONS: The new ISE Module E1200 is comparable with the ABL835 flex and KoneLab 30i and therefore may be used for routine analysis of serum adjusted Ca2+ (at pH 7.4). The measured adjusted Ca2+ (at pH 7.4) was less comparable with very poor agreement to total calcium measured on the Dimension Vista 1500 system.

Retrospective Evaluation of Two Fast-track Strategies to Rule Out Acute Coronary Syndrome in a Real-life Chest Pain Population.

BACKGROUND: The European Society of Cardiology (ESC) guideline on non-ST-elevation acute coronary syndrome (N-STE ACS) proposed a new ACS rule-out protocol. OBJECTIVES: To evaluate this new tool, which uses diagnostic levels of high-sensitivity troponin T (hs-TnT; > 14 ng/L) in a slightly modified version and compare this to a recently proposed approach using undetectable levels of hs-TnT to rule out patients. METHODS: There were 534 consecutive patients with suspected ACS included. Protocol 1: symptom duration, hs-TnT at 0 and 6-9 h, Global Registry of Acute Coronary Events (GRACE) score, and symptom status at 6-9 h. Protocol 2: a single blood sample of hs-TnT. The primary endpoint was a discharge diagnosis of ACS by blinded adjudication. Secondary endpoints were ACS re-admission < 30 days and 1-year mortality. RESULTS: Protocol 1 classified 434/534 (81%) patients, with 27.9% being ruled out. All myocardial infarctions were correctly ruled in, but 15 cases of unstable angina were missed, resulting in a sensitivity and negative predictive value of 87.3% (79.6-92.5%) and 87.6% (80.4-92.9%), respectively. Protocol 2 ruled out 17.5% of the population, yielding a sensitivity and negative predictive value of 94.1% (88.2-97.6%) and 90.8% (81.9-96.2%), respectively. Both protocols correctly ruled in 2/3 patients with ACS re-admission < 30 days and 55/56 1-year fatalities. CONCLUSION: The present study confirms the diagnostic value of a modified version of the ESC rule-out protocol (Protocol 1) in N-STE ACS patients, but also suggests that a simpler protocol using undetectable levels of hs-TnT (Protocol 2) could provide a similar or even superior sensitivity.

Assessing HER2 amplification by IHC, FISH, and real-time polymerase chain reaction analysis (real-time PCR) following LCM in formalin-fixed paraffin embedded tissue from 40 women with ovarian cancer.

We compare HER2 receptor amplification analysis by immunohistochemistry (IHC), fluorescence in situ hybridization (FISH), and real-time polymerase chain reaction (real-time PCR) DNA copy-number assay following laser capture microdissection (LCM) in formalin-fixed paraffin embedded tissue from 40 women with verified ovarian cancer. We speculate that LCM should result in a more accurate assessment of HER2 amplification in our real-time PCR assay compared with IHC and FISH. HER2 overexpression measured by IHC, FISH, or real-time PCR was found in 5.0%, 5.0%, and 22.5%, respectively. HER2 negative results measured by IHC, FISH, or real-time PCR were found in 95%, 92.5%, and 60.0%, respectively. Analysis failed for IHC, FISH, or real-time PCR in 0%, 2.5%, or 17.5% of cases. Concordance between IHC and FISH, IHC and real-time PCR, or FISH and real-time PCR were 89.7%, 72.7%, or 78.1%, respectively. Only few ovarian cancer patients were HER2 overexpressed measured by IHC or FISH and thus could be eligible for antibody-based therapy with trastuzumab (Herceptin). Interestingly, we find an increased number of HER2 positive patients by real-time PCR analysis on microdissected cancer cells, suggesting a number of HER2 positive patients not detected by current methods. Thus, the concept of quantitative measurement of HER2 on microdissected cancer cells should be explored further.

[What is the pedagogical development function of Region East, Denmark used for?]. / Hvad bruges Den Paedagogisk Udviklende Funktion i Region Øst til?

Implementing a reform of postgraduate medical education in Denmark (2004), a pedagogical development function (PDF) which employs clinical associate professors (CAP) was established. To evaluate the impact of the PDF and the CAP, 1,355 questionnaires were mailed to physicians in eastern Denmark: 687 (51%) replied, 114 (17%) expressed knowledge of the PDF and 75 (11%) reported a personal contact to the PDF. The rather low knowledge of the PDF may be due to the CAPs' involvement in several educational functions at the same time which may impede identification of the ''true" efforts of the CAP/PDF.

[Diagnosing lactose intolerance in adults]. / Diagnosticering af laktoseintolerans hos voksne.

INTRODUCTION: Primary lactose malabsorption, adult type, is associated with the genotype CC in a lactase gene regulatory sequence (LCT-13910). In contrast, the genotype CT or TT in this position correlates with normal lactose absorption. Genotyping was implemented for routine testing of patients for primary lactose intolerance. We estimated the frequency of genotypes in a group of blood donors and compared it with the frequency among patients. MATERIALS AND METHODS: In total, 478 patients admitted to a hospital or to a specialist in gastroenterology and 100 blood donors were genotyped. DNA was obtained, and the relevant DNA sequence was amplified by real-time polymerase chain reaction (PCR) and analysed by the use of melting curve analysis. RESULTS: Among blood donors, the allelic distribution was 8% CC, 38% CT and 54% TT, whereas 14% CC, 37% CT, 48% TT was found in the patient group. CONCLUSION: Compared with the control group, the frequency of the CC genotype is almost doubled in the genotyped patients. Genotyping proved to be a convenient tool for routine clinical testing.