Artificial Intelligence - Perception of Clinical Laboratories' Technical Staff a Nationwide Multicentre Survey in Pakistan.

Introduction: As Artificial Intelligence (AI) technology continues to assimilate into various industries, there is a huge scope in the healthcare industry specifically in clinical laboratories. The perspective of the laboratory professionals can give valuable insight on the ideal path to take for AI implementation. Methods: The study utilized a cross-sectional survey design and was conducted at the section of Chemical Pathology, Department of Pathology and Laboratory Medicine, the Aga Khan University (AKU), Karachi, Pakistan in collaboration with Consultant Pathologists of 9 clinical laboratories associated with teaching hospitals across Pakistan from October-November 2023. The survey was for a duration of 2 weeks and was circulated to all working laboratory technical staff after informed consent. Results: A total of 351 responses were received, of which 342 (male=146, female=196) responses were recorded after exclusion. Respondents ranged from technologists, faculty, residents, and coordinators, and were from different sections (chemical pathology, microbiology, haematology, histopathology, POCT). Out of the total 312 (91.2%) of respondents stated that they were at least somewhat familiar with AI technology. Experts in AI were only 2.0% (n=7) of all respondents, but 90% (n=6) of these were < 30 years old. 76.3% (n=261) of the respondents felt the need to implement more AI technology in the laboratories, with time saving (26.1%) and improving performances of tests (17.7%) cited to be the greatest benefits of AI. Security concerns (n=144) and a fear of decreasing personal touch (n=143) were the main concerns of the respondents while the younger employees had an increased fear of losing their jobs. 76.3% were in favour of an increase in AI usage in the laboratories. Conclusion: This study highlights a favourable perspective among laboratory professionals, acknowledging the potential of AI to enhance both the efficiency and quality of laboratory practices. However, it underscores the importance of addressing their concerns in the thoughtful implementation of this emerging technology.

Diagnoses and Outcomes of Patients with Suspicion of Acute Coronary Syndrome and Raised High Sensitive Troponin I: A Single Center Study from Pakistan.

Objectives Troponins are classically raised in acute coronary syndrome (ACS) although other cardiovascular and non-cardiovascular causes are recognized. We aimed to see the association of high sensitivity (Hs) Troponin I values exceeding the sex-specific 99th percentile upper reference limit (URL) with diagnoses, emergency department (ED) outcomes, 30-day outcomes of admitted patients and predictors of ACS in both genders. Materials and Methods A retrospective study of all patients presenting to the emergency department from January 2019 to April 2021 with suspicion of ACS and Hs-Troponin I values greater than the sex-specific 99th percentile URL. Statistical Analysis SPSS version 24 was used, Pearson's chi-square tests, Fisher's exact test, Kruskal-Wallis test, Mann-Whitney U test, and odds ratios, including the 95% confidence intervals, for each characteristic were used for analysis. A p -value of < 0.05 was considered significant. Results There were a total of 5,982 patients (3,031 males, 2,951 females), out of which 878 patients were admitted under the cardiology specialty. In patients who were admitted to the ward, mortality was higher in females (8.2%) with less than a 10-fold rise in Hs-Troponin I while similar in both genders (7.6%) in patients with Hs-troponin I greater than 10-fold of sex-specific 99th percentile URL. Raised low-density lipoprotein-cholesterol was a significant factor associated with 2.4 times higher odds of ACS. Conclusion Women with Hs-Troponin values up to 10 times the URL, i.e., 15.6-160 ng/L have higher mortality than their male counterparts. LDL-cholesterol is a significant risk factor for ACS which should be controlled for its prevention.

Development of a virtual classroom for pre-analytical phase of laboratory medicine for undergraduate medical students using the Delphi technique.

BACKGROUND: Amongst the pre-analytical, analytical, and post-analytical phase of laboratory testing, pre-analytical phase is the most error-prone. Knowledge gaps in understanding of pre-analytical factors are identified in the clinical years amongst undergraduate students due to lack of formal teaching modules on the pre-analytical phase. This study was conducted to seek experts' consensus in Clinical Chemistry on learning objectives and contents using the Delphi technique with an aim to develop an asynchronous virtual classroom for teaching pre-analytical factors of laboratory testing. METHODS: A mixed method study was conducted at the Aga Khan University. A questionnaire comprising of 16 learning objectives and their associated triggers was developed on Google Docs for developing the case vignettes. A four-point Likert Scale, which included strongly agree, agree, disagree and strongly disagree, was utilized for the learning objectives. An open-ended question was included for experts to suggest new items for inclusion. A cut off of at least 75% agreement was set to establish consensus on each item. A total of 17 Chemical Pathology faculty from 13 institutions across Pakistan were invited to participate in the first round of Delphi. Similar method of response was used in round two to establish consensus on the newly identified items suggested by the faculty in round 1. Later, the agreed-upon objectives and triggers were used to develop interactive scenarios over Moodle to concurrently test and teach medical students in a nonchalant manner. RESULTS: A total of 17 responses were received in Round 1 of the Delphi process (response rate = 100%), while 12 responses were received in Round 2 (response rate = 71%). In round 1, all 16 learning objectives reached the required consensus (≥ 75%) with no additional learning objectives suggested by the experts. Out of 75 triggers in round 1, 61 (81.3%) reached the consensus to be included while 39 were additionally suggested. In 2nd round, 17 out of 39 newly suggested triggers met the desired consensus. 14 triggers did not reach the consensus after two rounds, and were therefore eliminated. The virtual classroom developed using the agreed-upon learning objectives and triggers consisted of 20 items with a total score of 31 marks. The questions included multiple choice questions, fill in the blanks, drag and drop sequences and read-and-answer comprehensions. Specific learning points were included after each item and graphs and pictures were included for a vibrant experience. CONCLUSION: We developed an effective and interactive virtual session with expert consensus on the pre-analytical phase of laboratory testing for undergraduate medical students which can be used for medical technologist, graduate students and fellows in Chemical Pathology.

Evaluation of serum neuron specific enolase levels among patients with primary and secondary burning mouth syndrome.

INTRODUCTION: Burning mouth syndrome is a painful condition of the oral cavity with ambiguous pathogenesis and diagnosis. Neuron-specific enolase is increased in several conditions including peripheral neuropathy of diabetes, ophthalmopathies, spinal cord injuries and tumors. Evidence on association of burning mouth syndrome and neuron-specific enolase is limited. AIM: This study aims to evaluate neuron-specific enolase levels in primary and secondary burning mouth syndrome patients and compare the levels of neuron-specific enolase with associated conditions in secondary burning mouth syndrome. METHODS: One hundred and twenty-eight patients of more than 18 years of age with no gender predilection and having clinical symptoms of burning mouth syndrome and 135 healthy subjects were included. All the patients fulfilled Scala's criteria for the diagnosis of burning mouth syndrome, including "primary" (idiopathic) and "secondary" (resulting from identified precipitating factors) burning mouth syndrome patients. Blood samples were obtained from burning mouth syndrome patients. Serum neuron-specific enolase was evaluated using enzyme-linked immunosorbent assay. To compare means and standard deviations, among primary and secondary burning mouth syndrome, data was analysed with analysis of variance and multiple comparisons test. RESULTS: The mean age of the study participants for burning mouth syndrome and healthy subjects was 53.30 and 51.6 years, respectively. Amongst the secondary burning mouth syndrome group, 32 (25%) of the patients had menopause, 15 (11.7%) had diabetes, eight (6.2%) of the patients had nutritional deficiency, seven (5.4%) had combined diabetes, menopause, and depression, six (4.6%) had combined diabetes and depression, four (3.1%) were diagnosed with Sjögren's syndrome. A minor percentage of 2.3% (three) had gastroesophageal reflux disease, while the remaining three (2.3%) patients in the secondary burning mouth syndrome group were on anti-depressants. There was a statistically significant increase in the levels of neuron-specific enolase in primary burning mouth syndrome as compared to the secondary burning mouth syndrome and healthy groups. Among the subgroups of secondary burning mouth syndrome, diabetic individuals showed a significant increase in neuron-specific enolase level when compared with other conditions in the secondary burning mouth syndrome patients.Discussion and conclusion: The raised serum neuron-specific enolase levels in patients suffering from primary burning mouth syndrome highlight a possible neuropathic mechanism. It was also increased in the sub-group of secondary burning mouth syndrome patients having diabetes. Although it cannot be ascertained whether the deranged values in the diabetic group were due to burning mouth syndrome or due to diabetes, the raised quantity of neuron-specific enolase in the primary burning mouth syndrome group is a reliable diagnostic indicator. Future studies on the assessment of neuron-specific enolase levels as a diagnostic tool for onset and management of primary and secondary burning mouth syndrome are recommended.

Diagnostic Accuracy of Serum Procalcitonin (PCT) as an Early Biomarker of Neonatal Sepsis using Blood Culture as Gold Standard.

OBJECTIVE: To ascertain the diagnostic accuracy of serum PCT as an early biomarker of neonatal sepsis using blood culture as gold standard, so that the condition could be diagnosed and managed early to prevent and reduce morbidity and mortality in neonates.  Study Design: Cross-sectional study. PLACE AND DURATION OF STUDY: Dr. Ziauddin University Hospital, Karachi, from March 2019 to December 2019. METHODOLOGY: A total of 171 neonates, 1-29 days of age, presented with clinical diagnosis of neonatal sepsis, were included in this study. Patients' data regarding age, gender, birth weight, prematurity and premature rupture of membranes (PROM) were collected. Blood cultures were performed in Microbiology Department; and Serum PCT was analyzed on Electrochemiluminescence Immunnoassay Analyzer (Cobas e601). Diagnostic accuracy, including sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of PCT were calculated with contingency tables using blood culture findings as gold standard. RESULTS: Out of 171 clinically diagnosed cases of neonatal sepsis, 86 (50.3%) were confirmed as having neonatal sepsis (blood culture positive). There was a significant difference in serum PCT levels in both the groups. The sensitivity of PCT was 97.7%; specificity 70.6%; PPV 77.1; NPV 96.8%; likelihood ratio of a positive test (LR+ve) 3.32; likelihood ratio of a negative test (LR -ve) 0.03, and cumulative diagnostic accuracy of PCT 84.2%. CONCLUSION: PCT is a very useful biomarker for the early diagnosis of neonatal sepsis, showing 84.2% diagnostic accuracy. Thus PCT can help in making early clinical decisions regarding management of patients. Key Words: Diagnostic accuracy, PCT, Neonatal sepsis.

Salivary Interleukin 1-beta levels and clinical periodontal parameters in habitual naswar users and non-users.

OBJECTIVES: Aim of our study was to assess the expression of salivary Interleukin 1-beta (IL-1ß) and clinical periodontal parameters in naswar users and non-users (controls). METHODS: Eighty four individuals (forty-two naswar users and forty-two controls) were included in the study which was conducted between August 2017 and May 2018. Salivary IL-1ß levels, plaque index (PI), bleeding on probing (BOP), probing depth (PD) and clinical attachment loss (CAL) was assessed in all the participants. RESULTS: PD of 4mm (p<0.05), PD of 5-6mm (p<0.05), CAL (p<0.001) and levels of salivary IL-1ß (p<0.05) were significantly higher among naswar users as compared to controls while PI, BOP and number of missing teeth showed no significant difference among the two groups (p>0.05). CONCLUSION: Periodontal inflammatory conditions were worse and salivary IL-1ß levels were elevated in naswar users as compared to controls.

Differential expression of salivary S100A7 in oral submucous fibrosis.

AIM: To investigate the expression of salivary S100A7 levels among patients with oral submucous fibrosis (OSF) and healthy controls. METHOD: A total number of 60 participants were included in the study (30 OSF cases and 30 healthy controls). Demographic data was collected using a structured baseline questionnaire. Salivary S100A7 levels were quantified using enzyme-linked immunosorbent assay. Data was analyzed using Student t-test. Pearson correlation test was used to evaluate correlation between S100A7 levels and independent variables such as frequency and duration of areca nut use, gutka use, and mouth opening. RESULTS: The mean value of salivary S100A7 for OSF group was 0.275 ng/ml, whereas mean value of salivary S100A7 for healthy controls was 0.195 ng/ml. Student t-test indicated that there was statistically significantly higher levels of S100A7 in OSF group as compared to healthy controls (p < .001). When the clinical variables of individual groups were analysed, a significant negative correlation was found between salivary S100A7 and duration of areca nut (p = .009) and gutka chewing (p = .03), whereas a significant positive correlation was found for mouth opening (p = .04). CONCLUSION: OSF presented higher levels of salivary S100A7 levels as compared with healthy individuals and may be used as surrogate measure to identify subjects at risk for OSF.

Diagnostic Accuracy of Risk of Ovarian Malignancy Algorithm (ROMA) in Post-Menopausal Patients with Ovarian Mass.

OBJECTIVE: To determine the diagnostic accuracy of ROMA in postmenopausal women with history of ovarian mass. STUDY DESIGN: Observational study. PLACE AND DURATION OF STUDY: Dr. Ziauddin University Hospital, Karachi, from May 2014 to June 2015. METHODOLOGY: Two hundred and sixty postmenopausal women of 40-65 years of age with ovarian masses, planned for surgery, were included in the study. Their samples were obtained preoperatively and analysed on Abbot Architect i1000 SR immunoassay analyser for quantitative estimation of tumor markers, i.e. HE4 and CA125. By combination of these two tumor markers, ROMA scores were calculated and studied after histopathological verification of masses. RESULTS: Total number of patients were 260, out of which 122 (46.9%) were diagnosed as having ovarian cancer, while 138 (53.0%) were diagnosed as benign condition. Median ROMA score levels in patients with malignant masses were 95.58 (IQR=44.4) as compared to 20.6 (IQR=14) in benign masses. ROMA had sensitivity 92.6% (CI=86.47-96.04), specificity 78.3% (CI=70.09-83.82), positive predictive value 79% (CI=70.87-84.29), negative predictive value 92.3% (CI=86.02-95.9) and positive likelihood ratio 4.26, while negative likelihood ratio 0.1. Diagnostic accuracy of ROMA was 85%, based on ROC curve analysis. ROMA had the highest sensitivity in detecting ovarian carcinoma. CONCLUSION: ROMA is a very useful diagnostic tool for the preoperative stratification of patients with ovarian masses showing 85% diagnostic accuracy. However, there is need of more studies with homogenous laboratory procedures for HE4 and CA125 assays as well as patients, selection criteria, so we can draw firm conclusion about utility of ROMA in clinical setups.

The glomerular filtration rate: comparison of various predictive equations based on serum creatinine with conventional creatinine clearance test in Pakistani population.

INTRODUCTION: To compare the conventional creatinine clearance measured on 24-h urine collection with the estimated Glomerular Filtration Rate by Cockcroft & Gault (CG) and Modification of Diet in Renal Disease (MDRD) prediction equations in adults aged 20 years and above in Pakistani population. METHODS: All the patients, including inpatient admitted in hospital and outpatients, more than 20 years of age, reporting for the test of creatinine clearance in clinical chemistry department of Dr. Ziauddin Hospital clinical laboratory from 1st January to 31st December 2006 were studied. RESULTS: Comparison was made between conventional creatinine clearance and Cockcroft & Gault (CG) and Modification of Diet in Renal Disease (MDRD) prediction equations on 369 cases which revealed strong correlation with conventional creatinine clearance, MDRD equation has better correlation as compared with Cockcroft- Gault creatinine clearance. Statistical correlation was better in cases where serum creatinine was more than 1.50 mg/dl (r = 0.625 for Cockcroft- Gault creatinine clearance and r = 0.724 for MDRD equation) as compared when serum creatinine levels were less than 1.50 mg/dl (r = 0.608 for Cockcroft- Gault creatinine clearance and r = 0.596 for MDRD equation). There was positive bias in both calculated GFRs from conventional creatinine clearance in healthy as well as diseased population. CONCLUSION: The creatinine based formulas with their inherent property of convenience and cost effectiveness can be a useful tool for monitoring the progression of disease. They can be applied in clinical practice on our population but they should be interpreted with caution as they over estimate the GFR.