Sepse bacteriana é a maior causa de morbimortalidade na faixa etária pediátrica e neonatal. A detecção precoce do quadro séptico é difícil, devido os sinais iniciais da doença serem inespecíficos. A possibilidade da existência de exame laboratorial capaz de identificar precocemente quadros sépticos melhoraria o prognóstico desses pacientes. Várias proteínas de fase aguda foram estudadas como marcadores de infecção sendo a proteína C reativa (PCR) a mais utilizada. A procalcitonina (PCT), um pró-hormônio, encontra-se elevado precocemente em quadros sépticos em crianças e adultos. Estudo prospectivo com 14 crianças submetidas à cirurgia cardíaca com circulação extra-corpórea (CEC), com dosagens seriadas de procalcitonina e proteína C reativa, serviram como modelo de resposta inflamatória sistêmica sem infecção com dosagens antes da CEC, após a CEC no primeiro, segundo e terceiro dia após cirurgia, enquanto 14 crianças com sepse/choque séptico dosagens seriadas de PCT e PCR foram obtidas sequencialmente antes do tratamento antibioticoterápico e a cada dia até o terceiro dia. Em crianças sépticas a PCT demonstrou ser superior a PCR como marcador de sepse assim como para diferenciar quadros inflamatórios sistêmicos. / Bacterial sepsis is a major cause of morbidity and mortality in neonates and children. Early detection of bacterial sepsis is difficult because the first signs of this disease may be minimal or nonspecific. The availability of a laboratory test to accurately and rapidly identify septic neonates and children would be of great value in improving the outcome of these patients. Several acute-phase proteins have been used for the diagnosis of bacterial sepsis and C reactive protein (CRP) is the usual marker. It has been reported that the concentration of procalcitonin (PCT), a pro-hormone, is markedly higher in children and adults with sepsis. In a prospective study, 14 children were enrolled after cardiac surgery with cardiopulmonary bypass (CPB), these group represent the non infected children with inflammatory response. Blood samples were obtained before CPB, after CPB, on the first, second and third day after surgery. Another group with 14 children with sepsis or septic shock were enrolled, and blood samples were obtained before antibiotic start, on the first, second and third days. In septic children PCT concentration is a better diagnostic marker of sepsis and to differentiate inflammatory response than CRP.

Sepse é um importante problema de saúde pública, uma vez que seu tratamento gera altos custos a um sistema de saúde já sobrecarregado. É uma síndrome de alta mortalidade e morbidade que afeta, em geral, pacientes jovens com plena capacidade produtiva. A identificação e o tratamento precoce desta síndrome reduzem a morbimortalidade, assim como o custo. A proteína C reativa (PCR) e a procalcitonina (PCT) são bem estudadas como ferramentas para diagnóstico de infecção bacteriana em imunocompetentes, mas seu uso como ferramenta diagnóstica ainda não está estabelecido em pacientes imunossuprimidos. Portanto, a proposta deste estudo é avaliar a acurácia diagnóstica destes biomarcadores, em pacientes críticos imunossuprimidos (vírus da imunodeficiência adquirida  HIV positivos, portadores de tuberculose (TBC), cirróticos e transplantados). Como o uso da proteína C ainda não está estabelecido, a primeira questão de pesquisa investigou seu potencial diagnóstico quando comparado ao teste padrão (cultural). O segundo artigo comparou a PCR com a PCT. Para isto foram realizados dois artigos de revisão sistemática com metanálise. O primeiro artigo comparou a acurácia em determinar infecção bacteriana em imunossuprimidos da PCR ao teste padrão-ouro (as culturas). A primeira revisão incluiu 1.418 pacientes e demonstrou uma boa acurácia da PCR como biomarcador no diagnóstico de infecção bacteriana, apresentando sensibilidade de 69% e especificidade de 76% com uma área sob a curva (AUC) de 0,77. Os resultados encontrados são similares aos da literatura para imunocompetentes,(3) sensibilidade de 75%, especificidade de 67% e Área Sob a Curva Receiver Operating Characteristic (AUROC) de 0,92. Quando a PCT foi comparada com a PCR, ambos os biomarcadores mostraram acurácia moderada na utilização como ferrramenta de diagnóstico de infecção bacteriana, com um diagnóstico da razão de chances (DOR) de 7,24 (95% CI (2,83-14,60) para PCT e de 5,56 (95% CI (5,21-10,30) para PCR. A PCT e a PCR apresentaram sensibilidade de 69% e 68% e uma especificidade de 75% e 71%, respectivamente. Ambas mostraram resultados semelhantes, podendo ser utilizadas no diagnóstico de sepse em imunossupressos. / Sepsis is a major public health problem, since its treatment generates high costs, a health system already overburdened. A high mortality and morbidity syndrome affects, in general, young patients with full production capacity. The identification and early treatment of this syndrome reduce morbidity and mortality as well as the cost. C-reactive protein (CRP) and procalcitonin (PCT) are well studied as tools for diagnosis of bacterial infection in immunocompetent patients, but its use as a diagnostic tool is not yet established in immunocompromised patients. Therefore, the purpose of this study is to evaluate the diagnostic accuracy of these biomarkers in immunosuppresses critical patients (human immunodeficiency virus, cirrhotic and transplant). As the use of the c protein is not yet established, the first research question investigated their diagnostic potential when compared to the pattern (cultural). The second article compared to CRP and PCT. For this, there were two articles of a systematic review and meta-analysis. The first article compared the accuracy in determining bacterial infection in immunosuppresses of CRP to the gold standard (cultures). Our first review included 1,418 patients and showed good accuracy of CRP as a biomarker for the diagnosis of bacterial infection presenting a sensibility of 69% and 76% specificity with an area under the curve (AUC) 0.77. The results are similar to those found in the literature for immunocompetent,(3) sensitivity 75%, specificity of 67% and Area Under the Receiver Operating Characteristic Curve (AUROC): 0.92. When the PCT was compared with PCR, both biomarkers showed a moderately accurate for use as tool diagnostic bacterial infection with a Odds ratio diagnostic (DOR) 7.24 (95% CI (2.83-14.60) and PCT to 5:56 (95% CI (5.21-10.30) for CRP. the PCT and CRP had a sensitivity of 69% and 68% and a specificity of 75% and 71%, respectively. Both showed similar results may be used in the diagnosis of sepsis in immunosuppression.

Sepse é um importante problema de saúde pública, uma vez que seu tratamento gera altos custos a um sistema de saúde já sobrecarregado. É uma síndrome de alta mortalidade e morbidade que afeta, em geral, pacientes jovens com plena capacidade produtiva. A identificação e o tratamento precoce desta síndrome reduzem a morbimortalidade, assim como o custo. A proteína C reativa (PCR) e a procalcitonina (PCT) são bem estudadas como ferramentas para diagnóstico de infecção bacteriana em imunocompetentes, mas seu uso como ferramenta diagnóstica ainda não está estabelecido em pacientes imunossuprimidos. Portanto, a proposta deste estudo é avaliar a acurácia diagnóstica destes biomarcadores, em pacientes críticos imunossuprimidos (vírus da imunodeficiência adquirida  HIV positivos, portadores de tuberculose (TBC), cirróticos e transplantados). Como o uso da proteína C ainda não está estabelecido, a primeira questão de pesquisa investigou seu potencial diagnóstico quando comparado ao teste padrão (cultural). O segundo artigo comparou a PCR com a PCT. Para isto foram realizados dois artigos de revisão sistemática com metanálise. O primeiro artigo comparou a acurácia em determinar infecção bacteriana em imunossuprimidos da PCR ao teste padrão-ouro (as culturas). A primeira revisão incluiu 1.418 pacientes e demonstrou uma boa acurácia da PCR como biomarcador no diagnóstico de infecção bacteriana, apresentando sensibilidade de 69% e especificidade de 76% com uma área sob a curva (AUC) de 0,77. Os resultados encontrados são similares aos da literatura para imunocompetentes,(3) sensibilidade de 75%, especificidade de 67% e Área Sob a Curva Receiver Operating Characteristic (AUROC) de 0,92. Quando a PCT foi comparada com a PCR, ambos os biomarcadores mostraram acurácia moderada na utilização como ferrramenta de diagnóstico de infecção bacteriana, com um diagnóstico da razão de chances (DOR) de 7,24 (95% CI (2,83-14,60) para PCT e de 5,56 (95% CI (5,21-10,30) para PCR. A PCT e a PCR apresentaram sensibilidade de 69% e 68% e uma especificidade de 75% e 71%, respectivamente. Ambas mostraram resultados semelhantes, podendo ser utilizadas no diagnóstico de sepse em imunossupressos. / Sepsis is a major public health problem, since its treatment generates high costs, a health system already overburdened. A high mortality and morbidity syndrome affects, in general, young patients with full production capacity. The identification and early treatment of this syndrome reduce morbidity and mortality as well as the cost. C-reactive protein (CRP) and procalcitonin (PCT) are well studied as tools for diagnosis of bacterial infection in immunocompetent patients, but its use as a diagnostic tool is not yet established in immunocompromised patients. Therefore, the purpose of this study is to evaluate the diagnostic accuracy of these biomarkers in immunosuppresses critical patients (human immunodeficiency virus, cirrhotic and transplant). As the use of the c protein is not yet established, the first research question investigated their diagnostic potential when compared to the pattern (cultural). The second article compared to CRP and PCT. For this, there were two articles of a systematic review and meta-analysis. The first article compared the accuracy in determining bacterial infection in immunosuppresses of CRP to the gold standard (cultures). Our first review included 1,418 patients and showed good accuracy of CRP as a biomarker for the diagnosis of bacterial infection presenting a sensibility of 69% and 76% specificity with an area under the curve (AUC) 0.77. The results are similar to those found in the literature for immunocompetent,(3) sensitivity 75%, specificity of 67% and Area Under the Receiver Operating Characteristic Curve (AUROC): 0.92. When the PCT was compared with PCR, both biomarkers showed a moderately accurate for use as tool diagnostic bacterial infection with a Odds ratio diagnostic (DOR) 7.24 (95% CI (2.83-14.60) and PCT to 5:56 (95% CI (5.21-10.30) for CRP. the PCT and CRP had a sensitivity of 69% and 68% and a specificity of 75% and 71%, respectively. Both showed similar results may be used in the diagnosis of sepsis in immunosuppression.

The overuse of antibiotics is a large problem in healthcare today, accelerating the development of microbial resistance to antibiotics. Antibiotic stewardship campaigns have been implemented to help clinicians curb their use. Procalcitonin is a serum peptide and marker of inflammation secreted in response to microbial toxins. For this reason it is more specific to bacterial infections than other markers of general inflammation , like Creactive protein. The population of patients with sepsis in the Intensive Care Unit is one in which extended durations of antibiotics are used. The FDA has approved use of procalcitonin to guide de-escalation of antibiotic therapy in critically ill patients with sepsis to avoid both antibiotic overuse and antibiotic related side effects. Review of current literature shows that procalcitonin is efficacious in reducing duration of antibiotic therapy in patients with sepsis in the ICU setting. This result, however, is not being observed in clinical practice. This discrepancy is due to the inappropriate use of procalcitonin that does not align with use outlined in randomized control trials. We propose a study to determine how procalcitonin is being used in clinical practice in four Boston area hospital Intensive Care Units. Through chart review, we will identify patients in the Intensive Care Unit with sepsis from 2013-2018 recording patient demographic information and patient characteristics. We will determine whether they had PCT measured during their stay, and if they did, whether or not discontinuation of antibiotics was in accordance with FDA’s proposed algorithm. We will aim to compare whether discontinuing antibiotic therapy in accordance with the FDA’s procalcitonin deescalation algorithm is associated with reduced duration of antibiotic therapy or incidence of Clostridium Difficile infection. In conducting this study, we hope to identify patterns of procalcitonin use in clinical practice and provide further evidence that using the algorithm to guide therapy can serve as an effective tool in reducing exposure to unnecessary antibiotics and the complications from their use.

Die Arbeit untersucht die Akute Phase Reaktion nach erfolgreicher kardiopulmonaler Reanimation. Untersuchungsgegenstand war der Verlauf unterschiedlicher Akute Phase Proteine und Procalcitonin in Abhängigkeit von verschiedenen klinischen Parametern. Ebenso wurde das Verhalten der Akute Phase Proteine bei gesunden Probanden unter kontrollierter systemischer Hypoxie untersucht, da die Hypoxie als Auslöser der Akute Phase Reaktion diskutiert wird. Außerdem wurde betrachtet, welche Parameter sich für die Diagnose einer nach der Reanimation auftretenden Ventilator-assoziierten Pneumonie eignen. In die Untersuchung wurden 33 reanimierte Patienten eingeschlossen sowie 7 Probanden, die sich freiwillig einer hypobaren Hypoxie ausgesetzt hatten. Die wesentlichen Resultate sind: 1) Die untersuchten Akute Phase Proteine verhalten sich nach kardiopulmonaler Reanimation wie dies in der Literatur für andere Genesen beschrieben ist. Das Procalcitonin zeigt gewisse Charakteristika eines Akute Phase Proteins, wobei die Daten eine abschließende Beurteilung nicht ermöglichen. 2) Die Konzentrationsänderungen der Akute Phase Proteine treten bei allen Patienten unabhängig von ihrem Krankheitsverlauf auf. Schlussfolgerung ist, dass nach kardiopulmonaler Reanimation unabhängig von der Ursache regelmäßig eine Akute Phase Reaktion auftritt. 3) Die Probanden zeigten unter hypobarer Hypoxie keine Akute Phase Reaktion, obwohl ein Anstieg der Erythropoetin-Konzentration eine Aktivierung der sauerstoffabhängigen Genexpression anzeigte. Der Sauerstoffmangel reicht deshalb zur Erklärung der Akute Phase Reaktion als alleinige Ursache nicht aus. 4) Der Verlauf der untersuchten Akute Phase Parameter bleibt von einer Ventilator-assoziierten Pneumonie als Komplikation unbeeinflusst. Das Procalcitonin zeigte hingegen bereits frühzeitig im Verlauf deutliche Unterschiede zwischen Patienten mit und ohne Ventilator-assoziierte Pneumonie. / The thesis paper studies the acute phase reaction after successful cardiopulmonary resuscitation. Focus were different acute phase proteins as well as procalcitonin in relation to different clinical parameters. Also the course of these acute phase proteins during hypobaric hypoxia in volunteers was studied, because hyoxia is being discussed as a potential cause of the acute phase reaction. Additionally it was determined, which parameters are suitable to diagnose a ventilator-associated pneumonia after resuscitation. The study included 33 resuscitated patients as well as 7 volunteers undergoing a hypobaric hypoxia. The main results are: 1) The acute phase proteins studied behave after cardiopulmonary resuscitation as described in the literature for other causes. Procalcitonin show certain aspects of an acute phase protein, however, the data do not permit a final judgment. 2) The changes in concentration of the acute phase proteins take place in all patients regardless of the case history. It can be concluded that after cardiopulmonary resuscitation always an acute phase reaction occurs. 3) The volunteers undergoing hypobaric hypoxia showed no acute phase reaction, even though a rise in erythropoetin concentration indicated an oxygen-dependent gene expression. The hypoxia alone therefore is not a sufficient explanation for the development of the acute phase reaction. 4) The course of the acute phase proteins studied is not influenced by a ventilator-associated pneumonia as complication. The course of procalcitonin, however, shows early significant differences between patients with and without ventilator-associated pneumonia.

Bakgrund och syfte Procalcitonin (PCT) används i sjukvården vid uppföljning av patienter med bakterieinfektion. Under rådande corona-pandemi har studier visat att förhöjt PCT är associerat med utvecklingen av en svår form av Sars-Cov2-infektion. Genom att mäta PCT kan tecken till sekundär bakterieinfektion identifieras och utvecklingen av svår sjukdomsbild förutspås.På Universitetssjukhuset Örebro (USÖ) sker analysen av PCT på instrumentet Cobas e411. Under den pågående pandemin pågår det nu diskussion kring att överföra PCT-analysen till instrumenten ADVIA Centaur XPT på USÖ istället eftersom detta instrument även finns i Lindesberg och Karlskoga. Analysen skulle därmed kunna ske på alla tre laboratorier. Metod Venöst blod med olika koncentrationer av PCT samlades in från 21 patienter. Proverna användes till patientjämförelse. Till inomserieprecision användes patientprover som poolats till en hög och en låg nivå. Till totalprecisionen användes hög och låg kontroll. Datan från patientjämförelsen bearbetades i Excel och presenterades i linjära regressioner och Bland altman-plot. Som sensitivitetsanalys upprepades den statistiska bearbetningen med de sju högsta värdena exkluderade. Resultat och slutsats Patientjämförelsen mellan Cobas e411 och ADVIA Centaur XPT 1070 samt mellan ADVIA Centaur XPT 1070 och 1071 visade en bra korrelation. ADVIA Centaur XPT mäter dock lägre än Cobas e411, vilket ses i Bland altman-plotten som en metodbias på 30%. Detta ses även efter sensitivitetsanalys med högre värden exkluderade och datan bearbetats på nytt. Precisionsmätningarna visade bra precision med låga CV% för både ADVIA Centaur XPT 1070 och 1071.Med hänsyn till resultatet betraktas bytet till ADVIA Centaur XPT som en risk, varför beslutet fattas att fortsättningsvis analysera PCT på Cobas e411. / Background and purpose The PCT-value is used for observing the development of illness in patients with bacterial infection. During the Covid 19-pandemic, studies have shown that an increased PCT predicts a severe Covid-19.At the University hospital of Örebro, USÖ, the PCT assay is analyzed on the Cobas e411 instrument. The hospitals of Lindesberg and Karlskoga cannot perform the analysis due to a lack of this instrumentation.Since Centaur instruments are available at all three hospitals, performing the analysis on these instruments instead of the Cobas would enable all three hospital laboratories in the county to offer PCT analysis. Method Venous blood with different PCT values where collected from 21 patients and analysed with Siemens ADVIA Centaur XPT and Roche Cobas e411. Within-run precision was tested using pooled samples of low and high PCT concentrations. Between-run precision was tested using controls of low and high PCT concentrations. The data was examined by linear regression and Bland altman-plots using Excel. As a sensitivity analysis, the seven highest values were excluded, and the statistical analysis was repeated. Results and conclusion Despite the values correlating well in the linear regression and the assay had a high precision with a low CV% for both ADVIA Centaur XPT 1070 and 1071, the ADVIA Centaur XPT-instrument systematically measures 30% lower compared to Cobas e411. This method bias could lead to a misclassification of Covid 19-patients. With respect to our results, we consider analysis on ADVIA Centaur XPT to be risky and thus choose to continue analysing on Cobas e411.

Les nourrissons âgés de moins de trois mois ont la particularité d’être à relativement haut risque d’infections bactériennes sévères (IBS), majoritairement représentées par les infections urinaires et en particulier celles plus invasives (IBI) que sont les méningites et les bactériémies. On ne dispose actuellement pas d’outil suffisamment fiable et d’un rapport coût-bénéfice bien évalué pour différencier les nourrissons fébriles porteurs d’une affection virale banale de ceux porteurs d’une infection bactérienne.Le travail doctoral avait pour objectifs d’évaluer l’épidémiologie et les pratiques de prise en charge françaises des infections bactériennes de l’enfant fébrile âgé de moins de trois mois admis aux urgences pédiatriques ainsi que des outils diagnostiques, tels que la bandelette urinaire et la procalcitonine dans cette population. Plus de 2000 nourrissons ont été inclus dans une étude prospective observationnelle multicentrique (PRONOUR) sur une période de trente mois d’octobre 2008 à Mars 2011.Nous avons dans un premier temps décrit les modalités de prise en charge de ces jeunes nourrissons fébriles et montré que les pratiques étaient hétérogènes entre les centres participants et variaient par rapport aux recommandations existantes.Nous avons dans un second temps, étudié les pratiques de dépistage des infections urinaires, IBS la plus fréquente dans cette tranche d’âge, et en particulier les performances de la bandelette urinaire. La majorité des urines étaient prélevées par poche collectrice et la bandelette urinaire avait une sensibilité pour la détection d’infection urinaire comparable à celle de l’analyse par microscopie avec cette méthode de recueil.Puis, nous avons réévalué les performances des algorithmes décisionnels existants pour la détection des enfants à faible risque d’IBS dans une nouvelle population (PRONOUR). Nous avons montré qu’ils avaient une valeur prédictive négative satisfaisante comme précédemment décrit, mais une faible valeur prédictive positive pour la distinction des enfants porteurs ou non d’une IBS.Enfin, les performances de la procalcitonine (PCT) dans la détection des IBS et IBI ont été calculées et comparées avec celles d’autres marqueurs inflammatoires usuels. La capacité discriminative de la PCT était excellente pour le diagnostique d’IBI et meilleure que celles des autres marqueurs inflammatoires. Pour la détection d’une IBS, la PCT avait des performances similaires à celles de la C-réactive protein.La prise en charge des nourrissons fébriles âgés de moins de trois mois est hétérogène et pourrait être améliorée par de nouveaux outils prédictifs La prise en charge des nourrissons fébriles âgés de moins de trois mois est hétérogène et pourrait être améliorée par de nouveaux outils prédictifs tels que l’utilisation de la procalcitonine et de la bandelette urinaire dans cette tranche d’âge. / The prevalence of severe bacterial infections (SBI),mainly represented by urinary tract infections is relatively high in infants less than three months of age and particularly those more invasive (IBI) that are meningitis and bacteremia. Current strategies to distinguish young infants with SBIs from those with viral infections are not absolutely reliable and their cost-effectiveness and the associated iatrogenic morbidity have not been extensively evaluated.The purposes of the study were to characterize the spectrum of disease, clinical outcomes and management of febrile infants aged three months or younger admitted to pediatric emergency department in France and to evaluate the performances of diagnostics tests that are urinary dipstick test and procalcitonin assay in this population. A prospective multicenter cohort study was conducted in 15 French pediatric emergency departments over a period of 30 months between October 2008 and March 2011(PRONOUR). More than 2000 infants were enrolled.First, we have described the management of these young febrile infants. We have showed that practices were heterogeneous between the participating centers and varied from the current guidelines.We have analyzed screening strategies of urinary tract infection, the most common SBI in this age group, and in particular we aimed to assess the test performances of urine dipstick test. Most of urine specimens were collected by bag. Dipstick tests on bag urine samples detected urinary tract infections in infants aged 7 to 92 days similarly to microscopy.Then, we have re-evaluated the performances of current strategies for identifying infants at low risk for SBI in a new population (PRONOUR). We have showed that current protocols maintained their good previously reported negative predictive values but have low positive predictive values to detect young infants with SBIs.Finally, the performances parameters of procalcitonine (PCT) for detecting SBI and IBI in this population were calculated and compared with usual biomarkers. Procalcitonin has better diagnostic accuracy than CRP for detecting IBI. The two tests perform similarly for identifying SBI in febrile infants aged 7 to 91 days.The management of febrile infants less than three months of age varied between centers should be improved by new predictive tests. The performance of PCT testing should encourage the development of decision-making rules incorporating PCT and urinary dipstick test.

京都大学 / 0048 / 新制・課程博士 / 博士(医学) / 甲第21258号 / 医博第4376号 / 新制||医||1029(附属図書館) / 京都大学大学院医学研究科医学専攻 / (主査)教授 松村 由美, 教授 伊達 洋至, 教授 中川 一路 / 学位規則第4条第1項該当 / Doctor of Medical Science / Kyoto University / DFAM

Procalcitonin (PCT) is a precursor protein of the hormone calcitonin and is encoded by the gene Calcitonin-1. In the Blekinge Regional, P-PCT is only analyzed in Karlskrona. The analysis is performed in the department of clinical chemistry on the Alinity i-series instrument. PCT indicates bacterial infections and therefore, it is important to have a backup method for the analysis when the instrument in the city of Karlskrona is out of order. The aim of this work was to verify the analysis method of P-PCT on the instrument Alinity i-series in the city of Karlshamn. Analysis method verification means to confirm and prove that the method meets the specified requirements. Verification was performed by analyzing 35 samples with different concentration of PCT on the master instrument in Karlskrona and on “Alinity 1” and “Alinity 2” in Karlshamn. The method was compared by studying correlation coefficient and bias. The precision was measured only on “Alinity 1” which would be the master instrument in Karlshamn. Precision was measured by analyzing 25 replicates at two control levels and then was 5 replicates of each control level analyzed over 5 days. The correlation was good and no significant bias between results from Karlskrona and “Alinity 1” and between results from “Alinity 1” and “Alinity 2”. Precision on “Alinity 1” meets the requirements. The conclusion was that verification of PCT on master instrument “Alinity 1” and slave instrument “Alinity 2” was approved and the backup method for the PCT analysis in Karlshamn was verified. / Prokalcitonin (PCT) är en peptidprekursor till hormonet kalcitonin och kodas av genen kalcitonin-1 (CALC-1). PCT används som biomarkör för bakteriella infektioner och sepsis. I Region Blekinge analyseras P-PCT bara i Karlskrona. Analysen utförs på avdelningen för Klinisk kemi på instrumentet Alinity i-serie Abbot. PCT indikerar bakteriella infektioner och av denna anledning efterfrågas av flera avdelningar. Därför är det viktigt att verifiera en analysmetod för P-PCT i Karlshamn, ifall instrumenten i Karlskrona är ur funktion. Syftet med arbetet var att verifiera analysmetoden för P-PCT på instrumentet Alinity i-serie Abbot i Karlshamn. Metodverifiering innebär att bekräfta och bevisa att metoden uppfyller specificerade krav. Metodverifiering utfördes genom att analysera 35 prover med olika PCT-koncentrationer på masterinstrument ”Shrek” i Karlskrona och på ”Alinity 1” och ”Alinity 2” i Karlshamn. Metoderna jämfördes genom att studera korrelationskoefficient och bias. Inom och total serie-precision mättes bara på ”Alinity 1” som ska vara masterinstrument i Karlshamn. Inom serie-precision mättes genom att analysera 25 replikat av två kontrollnivåer och total serie-precision genom att analysera 5 replikat/dag under 5 dagar. Resultaten blev att metoden på ”Alinity 1” hade en god korrelation med metoden på masterinstrument ”Shrek” och ingen signifikant bias observerades mellan metoderna. Inom och total serie-precision på ”Alinity 1” uppfyller kraven. Metoden på ”Alinity 2” hade en god korrelation med metoden på masterinstrument ”Alinity 1” och ingen signifikant bias observerades mellan metoderna. Slutsatsen var att verifiering av P-PCT på masterinstrument ”Alinity 1” och slavinstrument ”Alinity 2” var godkänd och därmed verifierades en backupmetod för analysen P-PCT i Karlshamn.

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