Clinical Diagnostic Process Research Articles

Examining the measurement equivalence of Alzheimer’s Disease Centre Neuropsychological Test Battery (Version 3) across two distinct cultures

AbstractBackgroundNeuropsychological assessments are important in clinical diagnostic process for dementia as it help early detection of cognitive difficulties. Prior to using neuropsychological test batteries across different populations, it is critical to standardize the battery to ensure consistency in the assessment process, as well as valid and comparable results across different settings. The Alzheimer’s Disease Centre Neuropsychological Test Battery (Version 3) (ADCNTB3) is a widely used battery that had shown sensitivity in detecting cognitive decline in MCI and early dementia, with minimal test repetition effects (Boccardi et. al., 2022). While norms are available in America, harmonization efforts are currently in place to adapt ADCNTB3 for European populations.MethodThis study examined whether ADCNTB3 could be adapted to Singapore (multi‐ethic Asian population), a culture distinctly different from America, and whether ADCNTB3 demonstrates measurement equivalence when adapted to the Singapore population. Following the qualitative process of cultural adaptation, the ADCNTB3 was administered to 266 community‐dwelling older persons with normal cognition in Singapore. Scores from these participants were then compared with 1064 random samples with normal cognition from National Alzheimer’s Coordinating Centre (NACC) to evaluate whether the ADCNTB3 has equivalent scores across the two distinct populations. Score‐difference between the 2 populations was computed using multiple linear regression (adjusted for age, education, gender, family history of dementia, cardiovascular conditions, psychiatric and neurological history, smoking, untreated hearing loss, obesity, MoCA total score, CDR sum of boxes, NPI‐Q total score) and equivalence scores are considered to be present if the 90% confidence interval of the adjusted score‐difference fall within the equivalence margin. A priori, we defined the equivalence margin as 0.5 Standard Deviation of tests from ADCNTB3, as this often defines the minimally important clinical significance (Sloan et al., 2005).ResultOther than working and delayed memory tasks, all other tests from the ADCNTB3 are not directly equivalent. Notably, Asians performed better in visuospatial task, but consistently performed poorer in most other tasks.ConclusionOther than working and delayed memory tasks, all other tests from the ADCNTB3 are not directly equivalent. Notably, Asians performed better in visuospatial task, but consistently performed poorer in most other tasks.

Using the axonal protein neurofilament light to distinguish psychiatric and neurodegenerative disorders across a program of clinical research studies

Introduction:There is an urgent need for clinical blood biomarkers which can rule in/out neurological disorders early in those with psychiatric symptoms, personality or behavioural changes and/or functional decline together with cognitive symptoms. The neuronal axonal protein neurofilament light (NfL) is released from damaged neuronal axons and can be measured in in blood and cerebrospinal fluid (CSF). We have undertaken a series of studies aimed at examining the clinical utility of blood and CSF NfL in assisting with the distinction between psychiatric and neurodegenerative / neurological disorders.Methods:Since 2016 we have measured blood and CSF NfL levels across multiple psychiatric and neurological populations recruited through Neuropsychiatry, Royal Melbourne Hospital and our collaborators (national and international). We have described our findings in a series of published studies. Data from our ongoing work, in larger cohorts and diagnostic groups, will be presented. The diagnostic groups include people with psychiatric disorders (schizophrenia, bipolar disorder, depression, functional neurological disorders), neurodegenerative disorders (Alzheimer’s disease, frontotemporal dementia, Huntington’s disease, Niemann-Pick Type C) and neurological disorders (e.g., epilepsy).Results:Our initial pilot study (n=129) found that CSF NfL was a promising biomarker in differentiating psychiatric from neurological disorders. In our larger follow up larger study (n=498) which included more diagnostic groups CSF NfL levels exhibited high accuracy (91%), sensitivity (92%), and specificity (87%) in differentiating psychiatric from neurological disorders, and distinguished behavioural variant frontotemporal dementia from frontal lobe syndrome phenocopies/mimics, with high accuracy. We have found that NfL is not elevated in people with treatment resistant schizophrenia compared to controls and is elevated in people with Niemann-Pick Type C compared to people with psychiatric disorders and controls. Further (unpublished) data has shown that these findings are replicated with plasma NfL levels across 400 further psychiatric, neurological and control participants.Conclusions:NfL is a highly promising biomarker which differentiates psychiatric from neurological disorders with high sensitivity and specificity. The translation of NfL levels into standard clinical practice could substantially improve the clinical diagnostic process in people with complex neuropsychiatric and cognitive disorders.

Automated extraction of speech and turn-taking parameters in autism allows for diagnostic classification using a multivariable prediction model.

Autism spectrum disorder (ASD) is diagnosed on the basis of speech and communication differences, amongst other symptoms. Since conversations are essential for building connections with others, it is important to understand the exact nature of differences between autistic and non-autistic verbal behaviour and evaluate the potential of these differences for diagnostics. In this study, we recorded dyadic conversations and used automated extraction of speech and interactional turn-taking features of 54 non-autistic and 26 autistic participants. The extracted speech and turn-taking parameters showed high potential as a diagnostic marker. A linear support vector machine was able to predict the dyad type with 76.2% balanced accuracy (sensitivity: 73.8%, specificity: 78.6%), suggesting that digitally assisted diagnostics could significantly enhance the current clinical diagnostic process due to their objectivity and scalability. In group comparisons on the individual and dyadic level, we found that autistic interaction partners talked slower and in a more monotonous manner than non-autistic interaction partners and that mixed dyads consisting of an autistic and a non-autistic participant had increased periods of silence, and the intensity, i.e. loudness, of their speech was more synchronous.

MO6-1 Clinical characteristics and diagnostic process of NAFLD-associated HCC

MO6-1 Clinical characteristics and diagnostic process of NAFLD-associated HCC

Therapy for Necrotic Fingertip Ischemia Secondary to Traumatic Arteriovenous Fistula

Background: This is the first report on an accidental arteriovenous fistula of the upper limb. We discuss in this publication the clinical presentation, diagnostic process and treatment options of arteriovenous fistula (AVF) that can be conservative and interventional. Case presentation: We are reporting a case of a 89-year old white man with a necrotic fingertip ischemia secondary to a traumatic AVF. A Doppler sonography showed an AVF between the metacarpal bones of the digits 1 and 2 and confirmed a hand and forearm vein dilation. A fistula ligation would be indicated as first-line therapy, which was rejected by the elderly multimorbid patient. Owning to risk of potential wound healing problems, lifetime medical management such as manicure of the right index is recommended. In case of injury, compression therapy should be performed. The follow up was without complication. Conclusion: A fistula ligation is the therapy of choice in a patient with an arteriovenous fistula of the upper limb.

Capillaroscopy and Endopat – Helpful Methods for the Early Assessment of Increased Cardiovascular Risk in Anorexia Nervosa?

Abstract Anorexia nervosa (AN) as a life-threatening eating disorder is linked to a high mortality risk with many deaths attributable to cardiovascular etiology. Cardiovascular complications in AN include structural as well as functional cardiac alterations, hemodynamic changes, and peripheral vascular abnormalities. Despite the fact that peripheral vascular abnormalities are not identified as a major AN complication, several manifestations of peripheral vascular dysregulation including Raynaud's phenomenon and endothelial dysfunction have been described and, therefore, warrant attention. This article briefly summarizes so far findings of microvascular alterations in AN patients and presents easily accessible and non-invasive procedures for a microvascular evaluation such as capillaroscopy and endothelium-related peripheral arterial tone (EndoPAT) which could be involved in the clinical diagnostic process for the earliest identification of an increased risk of later cardiovascular complications.

Gastrointestinal tract carcinoid with carcinoid syndrome in 63-year-old diver – a case report

Introduction: Carcinoid is a tumor that originates from neuroendocrine cells.[1] It was primarily named and described in 1907 by Siegfried Oberndorfer to characterize neoplasms located in GIST with a relatively indolent course.[2] Term “carcinoid” is now used to describe. neuroendocrine neoplasms, a subset of rare tumors, mostly sporadic, which are typically located in gastrointestinal tract but they may also appear beyond it (e.g. in thymus or lungs).[2,3] NET’s are highly differentiated and usually hormonally active. Biochemical proof of their presence can consist of a measurement of the released substances – serotonin, bradykinin, histamine, etc. [3]Carcinoid tumors derive from serotonin-producing enterochromaffin cells.[1] They contain high quantities of tryptophane that is transformed later into serotonin. This biogenic amine is responsible for occurrence of so called- carcinoid syndrome. It manifests with hot flushes, diarrhea, tachycardia, vertigo and excessive sweating.[3] The attacks usually last from 0,5 minutes up to half an hour and they can be triggered by food or alcohol consumption, liver palpation or general anesthesia. Due to excessive serotonin production, long lasting carcinoid might lead to right endocardial fibrosis with tricuspid valve and pulmonary valve dysfunction. [4] Description of the case: The following case describes the clinical history, diagnostic process, imaging studies and treatment applied to 63-year-old male professional diver who was admitted to University Hospital of Zielona Góra with a clinical picture that resembled carcinoid syndrome. The final diagnosis- carcinoid originating from the ileum- was settled after performing multiple studies. The patient was referred to the department of Endocrinology and Neuroendocrine Tumors in Silesian University Center in Katowice. He initiated therapy with Somatuline Autogel. The Tumor Board was conducted in order to determine the optimal treatment for the patient.

Haemophilia B in Algeria: Realities and therapeutic perspectives.

Haemophilia B is a debilitating hereditary coagulation disorder characterized by prolonged or spontaneous episodes of bleeding caused by a deficiency of endogenous factor IX. In Algeria, even though many studies are being carried out to evaluate the prevalence and management of haemophilia B, there is a paucity of locally published literature that can be used to understand the most recent information on the disease's epidemiology, diagnostic techniques and treatment options. The aim of this manuscript is to raise awareness among patients and family clinicians about current practices, recent developments and unmet needs related to haemophilia B in Algeria. A comprehensive literature search was conducted through online scientific databases to review publications regarding haemophilia B in Algeria. Exclusions of the review include case studies, interregional comparisons, abstract-only papers and studies outside the range of 2012-2022. The findings discussed relate to the epidemiology of haemophilia B in Algeria, the clinical diagnostic process, disease symptoms, the benefits of molecular and genetic testing, advancements in prophylactic care, as well as unmet needs hindering the progression of optimal haemophilia B management. These findings are crucial to encourage the maintenance of national registries with updated epidemiological data, facilitate early and timely detection of disease symptoms, improve the provision of diagnostic facilities and enhance the overall treatment landscape for better patient outcomes.

Repetitive mild traumatic brain injuries in children of abuse

Repetitive mild traumatic brain injuries in children of abuse

非アルコール性脂肪性肝疾患を背景とした肝細胞癌の臨床的特徴と診断契機に関する検討

2009年1月から2018年12月までの間に倉敷中央病院で治療した肝細胞癌（HCC）患者756例のうち，非アルコール性脂肪性肝疾患の診断基準を満たした65例を解析した．年齢の中央値は76歳で，36例（55.4%）が男性であり，29例（44.6%）に肝硬変を認めた．サーベイランスを受けていたのは肝硬変患者の65.5%，非肝硬変患者の25%であり，サーベイランスなし群では，他疾患評価時の画像検査で偶発的に発見された例が最も多かった．HCC診断におけるAFP，PIVKA-II，超音波検査の感度はそれぞれ30.8%，72.3%，93.8%であった．多変量解析においてサーベイランスの実施は良好な全生存期間と有意に関連していた．まずは肝硬変患者に対するサーベイランスを徹底することが重要であるが，通常サーベイランスの対象にならない非肝硬変患者に生じるHCCをいかに早期発見するかが今後の課題である．

Preliminary results of whole exome sequencing in a clinical hypertrophic cardiomyopathy cohort in India

Abstract Funding Acknowledgements Type of funding sources: None. Background Hypertrophic cardiomyopathy (HCM), characterized by unexplained left ventricular hypertrophy and outcomes ranging from normal life expectancy to heart failure and sudden cardiac death, has a global prevalence of about 1 in 500. Genetic testing helps to improve care of patients with HCM and their family members as children of carriers have a 50% chance of inheriting the disease. However, there is limited availability, awareness and application of genetic testing modalities, particularly whole exome sequencing (WES), in the management of HCM in India. Purpose This study aimed to analyze the results of WES in a clinical HCM cohort in India. Methods Patients with unexplained moderate to severe cardiomyopathy presenting to our centre from 2017 to 2022 and consenting for genetic testing were included in the study. Following a thorough clinical diagnostic process including 3-generational family history, electrocardiogram and echocardiogram in all patients and exercise stress test, Holter monitoring and cardiac magnetic resonance imaging where applicable, pre-test counseling was provided and WES performed using genomic DNA isolated from whole blood samples. A total of 33 affected individuals including 1 affected family member from 32 families were processed for genetic testing. A multidisciplinary team comprising of cardiologist, cardiothoracic surgeon, physician with expertise in cardiogenetics, geneticist and genetic counselor carried out the study in a tertiary cardiac centre. Results Age of the probands (n=32) at the time of the study was 47.8±15.9 years and 24 (75%) were males. There was concomitant hypertension in 11 (34%), type 2 diabetes mellitus in 6 (19%), arrhythmias in 6 (19%) and coronary artery disease in 2 (6%) probands. Obstructive HCM was present in 2 (6%) probands. Disease-causing significant variants (Pathogenic/Likely pathogenic) were detected in 8 (25%, Table), variants of uncertain significance in 17 (53%) and no significant variants were detected in 7 cases. Cascade genetic testing of significant variants among 7 family members of 4 probands showed segregation of the pathogenic variant in 4 asymptomatic carriers. Conclusions The yield of whole exome sequencing in a clinical HCM cohort in India was 25%. Of note the rare variants of uncertain significance in the cardiomyopathy genes makes genetic counseling and disease management challenging. However, large-scale studies in the context of Indian population are expected to bring clarity on the role of these variants in disease manifestation. A multidisciplinary team approach incorporating genetic testing modalities such as whole exome sequencing and cascade screening is the way forward in the comprehensive management of patients with HCM and their families.

Sensorische Auffälligkeiten bei Autismus-Spektrum-Störung: Validierung und Adaptation des englischsprachigen „Sensory Perception Quotient“ (SPQ) von Tavassoli und Kollegen

Although the DSM-5 has emphasised the relevance of sensory abnormalities in autism spectrum disorders (ASD), there are hardly any measures to assess them in German speaking countries. The present study translated the "Sensory Perception Questionnaire" (SPQ) by Tavassoli et al. (2014) to German and validated this scale. The SPQ is a self-rating scale for adults which focuses on perceptual aspects rather than cognitive or motivational antecedents or consequences of such perceptual processes. A total of 188 subjects participated in this study, including n=85 participants with ASD and n=103 neurotypical controls. The autism spectrum quotient (AQ) and the empathy quotient (EQ) were also administered, the IQ was measured using the CFT20-R, and participants were clinically evaluated using the SKID-I. Alternative items were generated to improve the semantic and psychometric properties of the SPQ. Of the 92 original SPQ items, 33 separated the clinical groups significantly and linguistically clearly in the sense of sensory hyper-sensitivity. These items covered primarily the sensory modalities of hearing, touch and vision. Increased sensory hyper-sensitivity was associated with greater scores in the AQ and increased slightly with increasing age. Sensory hyper-sensitivity in participants with ASD was, however, not significantly correlated with the EQ and the IQ. Due to the item-analytical rather than dimensional item selection, the short versions presented here exhibit a clearly better group separation with comparable concurrent validities when compared to Tavassoli's short version of the scale. Pending replication and proper norming, the SPQ short version presented here can be employed for screening purposes and supplement the clinical diagnostic process.

Coronary CT angiography derived fractional flow reserve: opportunity for a win-win cooperation between cardiologists and radiologists

The advent of coronary CT angiography derived fractional flow reserve (CT-FFR) calculation technology has brought great improvements to the clinical diagnostic process and treatment decision-making towards coronary artery disease. In recent years, CT-FFR technology has gradually begun to be taken into clinical practice in China, however, currently, the popularization is not widespread, and it is imperative to further standardize the clinical application of CT-FFR technology. This paper focused on the opportunities, significance and challenges of CT-FFR application in China from the advantages and disadvantages perspectives of this new technology based on three international studies. Combined with specific national conditions and the latest evidence-based clinical medical results, this paper proposes a win-win cooperation initiative between cardiologists and radiologists for the reference and caution of both clinical practitioners and medical affairs bureaus.

Towards Machine Learning Algorithms in Predicting the Clinical Evolution of Patients Diagnosed with COVID-19

Predictive modelling strategies can optimise the clinical diagnostic process by identifying patterns among various symptoms and risk factors, such as those presented in cases of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), also known as coronavirus (COVID-19). In this context, the present research proposes a comparative analysis using benchmarking techniques to evaluate and validate the performance of some classification algorithms applied to the same dataset, which contains information collected from patients diagnosed with COVID-19, registered in the Influenza Epidemiological Surveillance System (SIVEP). With this approach, 30,000 cases were analysed during the training and testing phase of the prediction models. This work proposes a comparative approach of machine learning algorithms (ML), working on the knowledge discovery task to predict clinical evolution in patients diagnosed with COVID-19. Our experiments show, through appropriate metrics, that the clinical evolution classification process of patients diagnosed with COVID-19 using the Multilayer Perceptron algorithm performs well against other ML algorithms. Its use has significant consequences for vital prognosis and agility in measures used in the first consultations in hospitals.

Emulating Clinical Diagnostic Reasoning for Jaw Cysts with Machine Learning.

The detection and classification of cystic lesions of the jaw is of high clinical relevance and represents a topic of interest in medical artificial intelligence research. The human clinical diagnostic reasoning process uses contextual information, including the spatial relation of the detected lesion to other anatomical structures, to establish a preliminary classification. Here, we aimed to emulate clinical diagnostic reasoning step by step by using a combined object detection and image segmentation approach on panoramic radiographs (OPGs). We used a multicenter training dataset of 855 OPGs (all positives) and an evaluation set of 384 OPGs (240 negatives). We further compared our models to an international human control group of ten dental professionals from seven countries. The object detection model achieved an average precision of 0.42 (intersection over union (IoU): 0.50, maximal detections: 100) and an average recall of 0.394 (IoU: 0.50–0.95, maximal detections: 100). The classification model achieved a sensitivity of 0.84 for odontogenic cysts and 0.56 for non-odontogenic cysts as well as a specificity of 0.59 for odontogenic cysts and 0.84 for non-odontogenic cysts (IoU: 0.30). The human control group achieved a sensitivity of 0.70 for odontogenic cysts, 0.44 for non-odontogenic cysts, and 0.56 for OPGs without cysts as well as a specificity of 0.62 for odontogenic cysts, 0.95 for non-odontogenic cysts, and 0.76 for OPGs without cysts. Taken together, our results show that a combined object detection and image segmentation approach is feasible in emulating the human clinical diagnostic reasoning process in classifying cystic lesions of the jaw.

Radiomics Profiling Identifies the Value of CT Features for the Preoperative Evaluation of Lymph Node Metastasis in Papillary Thyroid Carcinoma.

Background: The aim of this study was to identify the increased value of integrating computed tomography (CT) radiomics analysis with the radiologists’ diagnosis and clinical factors to preoperatively diagnose cervical lymph node metastasis (LNM) in papillary thyroid carcinoma (PTC) patients. Methods: A total of 178 PTC patients were randomly divided into a training (n = 125) and a test cohort (n = 53) with a 7:3 ratio. A total of 2553 radiomic features were extracted from noncontrast, arterial contrast-enhanced and venous contrast-enhanced CT images of each patient. Principal component analysis (PCA) and Pearson’s correlation coefficient (PCC) were used for feature selection. Logistic regression was employed to build clinical–radiological, radiomics and combined models. A nomogram was developed by combining the radiomics features, CT-reported lymph node status and clinical factors. Results: The radiomics model showed a predictive performance similar to that of the clinical–radiological model, with similar areas under the curve (AUC) and accuracy (ACC). The combined model showed an optimal predictive performance in both the training (AUC, 0.868; ACC, 86.83%) and test cohorts (AUC, 0.878; ACC, 83.02%). Decision curve analysis demonstrated that the combined model has good clinical application value. Conclusions: Embedding CT radiomics into the clinical diagnostic process improved the diagnostic accuracy. The developed nomogram provides a potential noninvasive tool for LNM evaluation in PTC patients.

Temporomandibular Disorders. Part 1: Anatomy, Aetiology, Diagnosis and Classification

Temporomandibular disorders (TMD) are the most common causes of chronic pain in the orofacial region. The aetiology of TMD is complex owing to its multifactorial biopsychosocial nature. TMD shares many commonalities, and can be associated with, other chronic pain conditions. The physical and psychological impact of chronic pain on the individual can be far-reaching and should not be underestimated. This article, the first of a six-part series, aims to provide the reader with a background to TMDs as well as an overview of the clinical examination and diagnostic process for patients presenting with TMD-related pain. CPD/Clinical Relevance: Clinicians should be aware of the signs and symptoms of TMD with which their patients might present and understand the complex nature of chronic pain conditions.

Spanish National Registry of Paediatric Coeliac Disease: Changes in the Clinical Presentation in the 21st Century.

Over the last several decades, there has been a tendency towards a predominance of less symptomatic forms of coeliac disease (CD) and an increase in the patient age at diagnosis. This study aimed to assess the clinical presentation and diagnostic process of paediatric CD in Spain. A nationwide prospective, observational, multicentre registry of new paediatric CD cases was conducted from January 2011 to June 2017. The data regarding demographic variables, type of birth, breast-feeding history, family history of CD, symptoms, height and weight, associated conditions, serological markers, human leukocyte antigen (HLA) phenotype, and histopathological findings were collected. In total, 4838 cases (61% girls) from 73 centres were registered. The median age at diagnosis was 4 years. Gastrointestinal symptoms were detected in 71.4% of the patients, and diarrhoea was the most frequent symptom (45.9%). The most common clinical presentation was the classical form (65.1%) whereas 9.8% ofthe patients were asymptomatic. There was a trend towards an increase in the age at diagnosis, proportion of asymptomatic CD cases, and usage of anti-deamidated gliadin peptide antibodies and HLA typing for CD diagnosis. There was, however, a decreasing trend in the proportion of patients undergoing biopsies. Some of these significant trend changes may reflect the effects of the 2012 ESPGHAN diagnosis guidelines. Paediatric CD in Spain is evolving in the same direction as in the rest of Europe, although classical CD remains the most common presentation form, and the age at diagnosis remains relatively low.

Clinical Manifestation and Diagnostic Process of Celiac Disease in Poland-Comparison of Pediatric and Adult Patients in Retrospective Study.

The diagnosis of celiac disease (CD) may be delayed due to non-specific clinical symptoms. The aim of the study was to evaluate the clinical manifestation and diagnostic process of CD in Polish children and adults. Methods: The members of the Polish Coeliac Society (n = 2500) were asked to complete a questionnaire on socio-demographic factors, clinical and diagnostic aspects of CD. The analysis was based on 796 responses from patients with confirmed CD diagnosis, and included 224 (28.1%) children and 572 (71.9%) adults. Results: The mean duration of symptoms prior to CD diagnosis in children was significantly shorter than in adults (p < 0.001), and amounted to 3.1 and 9 years respectively. The most frequent symptoms before CD diagnosis were abdominal pain and bloating in children (70.4%), and chronic fatigue in adults (74.5%). Although almost all CD patients claimed to strictly avoid gluten after CD diagnosis, symptoms were still present in the majority of these respondents. No comorbid diseases were reported by 29.8% of children and by 11.7% of adults (p < 0.001). Conclusions: the results indicate that CD diagnosis is delayed in Poland, especially in adults, and clinicians should be aware of the diversity in CD presentation.

Evaluation of clinical biochemical laboratory analytical process performance using sigma metrics and quality goal index

Background: Application of sigma matrics across clinical laboratory diagnostic process enables identification of errors in methods together with quality goal index can help point out the cause of unacceptable process performance. We believe the analytical performance of the clinical biochemistry laboratory standards do not meet the required quality according to six sigma standards. Aim and Objective: The study aimed at performance evaluation of clinical biochemical laboratory analytical process using sigma metrics and quality goal index. Methods: Sigma (σ) for the 20 analytes performed on HITACHI 7600 - 110 was calculated based on absolute bias, total allowable error (TEa) and coefficient of variation (CV). Two level internal quality control data obtained retrospectively from December 2020 to May 2021 was used to calculate the coefficient of variation. Bias was obtained from six month external quality control data. Total allowable error was obtained from three different sources. Quality goal index (QGI) was calculated to identify the cause of unwanted analyte performance. Results: Different sigma scores were obtained for analytes on different total allowable error standard, only triglyceride showed world class performance along all the three total allowable error standards. However, creatine kinase &amp; total bilirubin showed world class on clinical laboratory improvement amendment (CLIA) and biological variable database (BVD). On the other hand, glucose, and aspertate amino transferase had poor or unacceptable performance on all the total allowable error standards. Conclusion: Six sigma is an excellent tool in evaluating the quality performance of clinical biochemistry laboratory analytical process, quality goal index can help identify the problem and westgard rules can help design individual quality improvement strategy.