Insights from semi-structured interviews on integrating artificial intelligence in clinical chemistry laboratory practices.

BACKGROUND: Artificial intelligence (AI) is gradually transforming the practises of healthcare providers. Over the last two decades, the advent of AI into numerous aspects of pathology has opened transformative possibilities in how we practise laboratory medicine. Objectives of this study were to explore how AI could impact the clinical practices of professionals working in Clinical Chemistry laboratories, while also identifying effective strategies in medical education to facilitate the required changes. METHODS: From March to August 2022, an exploratory qualitative study was conducted at the Section of Clinical Chemistry, Department of Pathology and Laboratory Medicine, Aga Khan University, Karachi, Pakistan, in collaboration with Keele University, Newcastle, United Kingdom. Semi-structured interviews were conducted to collect information from diverse group of professionals working in Clinical Chemistry laboratories. All interviews were audio recorded and transcribed verbatim. They were asked what changes AI would involve in the laboratory, what resources would be necessary, and how medical education would assist them in adapting to the change. A content analysis was conducted, resulting in the development of codes and themes based on the analyzed data. RESULTS: The interviews were analysed to identify three primary themes: perspectives and considerations for AI adoption, educational and curriculum adjustments, and implementation techniques. Although the use of diagnostic algorithms is currently limited in Pakistani Clinical Chemistry laboratories, the application of AI is expanding. All thirteen participants stated their reasons for being hesitant to use AI. Participants stressed the importance of critical aspects for effective AI deployment, the need of a collaborative integrative approach, and the need for constant horizon scanning to keep up with AI developments. CONCLUSIONS: Three primary themes related to AI adoption were identified: perspectives and considerations, educational and curriculum adjustments, and implementation techniques. The study's findings give a sound foundation for making suggestions to clinical laboratories, scientific bodies, and national and international Clinical Chemistry and laboratory medicine organisations on how to manage pathologists' shifting practises because of AI.

Is HbA1c associated with birth weight? A multivariable analysis of Pakistani pregnant women.

AIM: Globally, one in seven infants is born with low birth weight and 3%-7% of infants are born with high birth weight, with the greatest burden noted in low- and middle-income countries. This study investigated the association between maternal prenatal glucose regulation and birth weight and the moderating effect of fetal sex among Pakistani women. METHODS: Secondary data from a prospective longitudinal study of healthy pregnant women from Pakistan (N = 189) was used. Participants provided a blood sample (12-19 weeks' gestational age) for the assessment of HbA1c (%). Birth weight (g) was collected following delivery. RESULTS: Higher maternal HbA1c was associated with higher birth weight (b = 181.81, t[189] = 2.15, p = 0.03), which was moderated by fetal sex (b = -326.27, t[189] = -2.47, p = 0.02), after adjusting for gestational age at birth, ethnicity, and pregnancy weight. Among women carrying a male fetus, every 1% increase in HbA1c predicted a 182 g increase in birth weight (b = 181.81, t[189] = 2.15, p = 0.03). CONCLUSIONS: Results extend research from high-income countries and indicate that fetal sex may have implications for glucose regulation in early to mid-pregnancy. Future research should examine sociocultural factors, which could elucidate potential mediating factors in the relation between HbA1c and birth weight in healthy pregnancies.

Development and validation of standard and real patient gallstone library using Fourier transform infra-red spectroscopy.

BACKGROUND: Analysis of the constituents of gallstones using various spectroscopic techniques assists in identification of the pathogenesis of gallstones. In the current study, using Fourier Transform Infra-Red (FTIR) Spectroscopy, a Gallstone Standard Library (GSL) and a Gallstone Real Patients' Library (GRPL) were developed and validated for gallstone composition analysis. METHODS: The study was conducted at the Department of Pathology & Laboratory Medicine, Aga Khan University, Pakistan. Pure standards (cholesterol, calcium carbonate, bilirubin and bile salts) and gallstone specimens were analyzed using FTIR Nicolet iS-5 Spectrometer from Thermo Fisher Scientific, USA. Thermo Scientific™ QCheck™ algorithm, embedded within the OMNIC™ software, was used to identify the unique spectral fingerprint of the patient samples to match with known, standard material. Matching of > 75% was considered acceptable. Validation for accuracy of the library was performed for twenty analyzed gallstones at an international reference lab. RESULTS: Concerted search analysis was performed against the developed GSL consisting of 71 "pure component" spectrum divided into 5 types to generate the library. For the Gallstone Real Patient Library (GRPL), 117 patient samples were analyzed. Ninety-eight gall stones (83.8%) out of 117 stones matched with the developed GSL. Majority stones were mixed stones (95.92%), with cholesterol being the primary component (91.83%). Results of the developed library were 100% in agreement with the reports received from the external reference lab. CONCLUSIONS: The library developed displayed good consistency and can be used for detection of gallstone composition in Pakistan and replace the traditional labor- and time-intensive chemical method of gallstone analysis.

Reference Intervals of Serum TSH from Mixed Distributions Using Truncation Points and the Kolmogorov-Smirnov Distance.

BACKGROUND: Serum TSH reference intervals (RIs) are methodology, population, and age specific. However, the ethical and practical challenges restrict the establishment of pediatric RIs using conventional approaches and advocates the use of indirect data mining-based algorithms. This study was carried out to estimate the reference interval of neonatal serum TSH in Pakistani population using an indirect approach. METHODS: A data mining of serum TSH results of neonates (≤ 1 month of age) from 2013 - 2018 was done. Two subgroups on the basis of age from birth to 5 days and 6 - 30 days were assessed. The German study group's pre-validated indirect algorithm 'KOSMIC' was utilized for the statistical analysis. RESULTS: A total of non-duplicate 82,299 neonatal serum TSH tests were retrieved over a period of 6 years, including 88% (n = 70,788) aged 0 - 5 days and 12% (n = 11,511) ranging from 6 days to 1 month. The estimated RIs for the first age partition was 0.7 (90% CI 0.6 - 0.8) to 15.5 (90% CI 12.9 - 16.2) and for the second group 0.7 (90% CI 0.5 - 0.9) to 7.8 (90% CI 6.1 - 9.9) µIU/mL. CONCLUSIONS: This study revealed age related trends in serum TSH. The study advocates the need for population specific RIs owing to the significant variations noted on comparison with previously published literature. Precise RIs become vital particularly when serum TSH is undertaken as a confirmatory test for presumptive positive results on newborn screening for congenital hypothyroidism.

Fostering teaching-learning through workplace based assessment in postgraduate chemical pathology residency program using virtual learning environment.

BACKGROUND: The principle of workplace based assessment (WBA) is to assess trainees at work with feedback integrated into the program simultaneously. A student driven WBA model was introduced and perception evaluation of this teaching method was done subsequently by taking feedback from the faculty as well as the postgraduate trainees (PGs) of a residency program. METHODS: Descriptive multimethod study was conducted. A WBA program was designed for PGs in Chemical Pathology on Moodle and forms utilized were case-based discussion (CBD), direct observation of practical skills (DOPS) and evaluation of clinical events (ECE). Consented assessors and PGs were trained on WBA through a workshop. Pretest and posttest to assess PGs knowledge before and after WBA were conducted. Every time a WBA form was filled, perception of PGs and assessors towards WBA, time taken to conduct single WBA and feedback were recorded. Faculty and PGs qualitative feedback on perception of WBA was taken via interviews. WBA tools data and qualitative feedback were used to evaluate the acceptability and feasibility of the new tools. RESULTS: Six eligible PGs and seventeen assessors participated in this study. A total of 79 CBDs (assessors n = 7 and PGs n = 6), 12 ECEs (assessors n = 6 and PGs n = 5), and 20 DOPS (assessors n = 6 and PGs n = 6) were documented. PGs average pretest score was 55.6%, which was improved to 96.4% in posttest; p value< 0.05. Scores of annual assessment before and after implementation of WBA also showed significant improvement, p value 0.039, Overall mean time taken to evaluate PG's was 12.6 ± 9.9 min and feedback time 9.2 ± 7.4 min. Mean WBA process satisfaction of assessors and PGs on Likert scale of 1 to 10 was 8 ± 1 and 8.3 ± 0.8 respectively. CONCLUSION: Both assessors and fellows were satisfied with introduction and implementation of WBA. It gave the fellows opportunity to interact with assessors more often and learn from their rich experience. Gain in knowledge of PGs was identified from the statistically significant improvement in PGs' assessment scores after WBA implementation.

Vitamin D and bone metabolism in breast cancer patients in Karachi, Pakistan.

Breast cancer is one of the common types of malignancy worldwide and in Pakistan. The heterogeneous disease itself and its complex treatment leads to various bone-affecting complications that make breast cancer patients more vulnerable to bone fractures. Vitamin D deficiency among these women worsens the condition and promotes breast cancer growth. Thus, the purpose of the study was to assess serum levels of 25-hydroxyvitamin D (25OHD) and bone markers in women suffering from breast cancer. Serum levels of 25OHD, alkaline phosphatase (ALP), bone specific ALP, calcium (Ca), phosphorus (P), magnesium (Mg), albumin (Alb) and beta carboxyl terminal collagen crosslink (ß-CTx) were analyzed in 201 histological diagnosed patient volunteers from breast cancer clinic. Vitamin D insufficiency was present among the total study population and deficiency was particularly observed among women with metastases. These patients had significantly increased serum levels of ß-CTx and bone specific ALP when compared with the non-metastatic group. No significant difference was observed in other biochemical parameters. A weak correlation between serum levels of 25OHD and ß-CTx was observed. Therefore, monitoring of serum levels of 25OHD and bone markers at the time of diagnosis and during the course of treatment will endeavor a better overall health status.

Burden of Zinc (Zn) deficiency: A high volume clinical laboratory data analysis.

A cross-sectional survey was done at the Section of Chemical Pathology, Department of Pathology and Laboratory Medicine, AKUH, Karachi, to determine frequency of Zn deficiency, the second major micronutrient deficiency in developing countries, in subjects coming for investigations. Data of plasma Zn, from Jan 2013 to Dec 2014 was analyzed and deficiency was labeled at <65ug/dl. Total 469 subjects were tested for plasma Zn levels over the period of 24 months and complete information was available for 422 subjects, included in final analysis. Median age of subjects was 13 yrs (IQR 7-35) and 57% were male. Mean plasma Zn levels of the total subjects were 105±42.6ug/dl. Out of the total subjects 13.5% (n=57) had Zn deficiency (mean plasma Zn 52±11 ug/dl), and most of them were of age group 6-16yrs. These findings advocate that diet of Pakistani children should be revised in order to provide sufficient amounts of Zn.

Error identification in a high-volume clinical chemistry laboratory: Five-year experience.

INTRODUCTION: Quality indicators for assessing the performance of a laboratory require a systematic and continuous approach in collecting and analyzing data. The aim of this study was to determine the frequency of errors utilizing the quality indicators in a clinical chemistry laboratory and to convert errors to the Sigma scale. MATERIALS AND METHODS: Five-year quality indicator data of a clinical chemistry laboratory was evaluated to describe the frequency of errors. An 'error' was defined as a defect during the entire testing process from the time requisition was raised and phlebotomy was done until the result dispatch. An indicator with a Sigma value of 4 was considered good but a process for which the Sigma value was 5 (i.e. 99.977% error-free) was considered well controlled. RESULTS: In the five-year period, a total of 6,792,020 specimens were received in the laboratory. Among a total of 17,631,834 analyses, 15.5% were from within hospital. Total error rate was 0.45% and of all the quality indicators used in this study the average Sigma level was 5.2. Three indicators - visible hemolysis, failure of proficiency testing and delay in stat tests - were below 5 on the Sigma scale and highlight the need to rigorously monitor these processes. CONCLUSIONS: Using Six Sigma metrics quality in a clinical laboratory can be monitored more effectively and it can set benchmarks for improving efficiency.

B-type natriuretic peptide versus amino terminal pro-B type natriuretic peptide: selecting the optimal heart failure marker in patients with impaired kidney function.

BACKGROUND: The effect of impaired kidney function on B-type natriuretic peptide (BNP) and N-terminal proBNP (NT-proBNP) is vague. This study was performed to examine the effect of kidney dysfunction on the afore-mentioned markers and determine appropriate cutoffs for systolic heart failure (SHF). METHODS: In this cross sectional study adults with estimated glomerular filtration rate (eGFR) <60 ml/min for ≥3 months were identified in consulting clinics from June 2009 to March 2010. SHF was defined as documented by a cardiologist with ejection fraction of < 40% and assessed by New York Heart Association classification (NYHA). Plasma was assayed for creatinine (Cr), BNP and NT-proBNP. RESULTS: A total of 190 subjects were enrolled in the study, 95 with and 95 without SHF. The mean age of patients was 58 (±15) years, 67.4% being males. Mean BNP levels showed a 2.5 fold and 1.5 fold increase from chronic kidney disease (CKD) stage 3 to stage 5 in patients with and without SHF respectively. NT-proBNP levels in non-heart failure group were 3 fold higher in CKD stage 5 compared to stage 3. Mean NT-proBNP levels were 4 fold higher in CKD stage 5 compared to stage 3 in patients with SHF. Optimal BNP and NT-proBNP cutoffs of SHF diagnosis for the entire CKD group were 300 pg/ml and 4502 pg/ml respectively. CONCLUSION: BNP and NT-proBNP were elevated in kidney dysfunction even in the absence of SHF; however the magnitude of increase in NT-proBNP was greater than that of BNP. BNP and NT-proBNP can be useful in diagnosing SHF, nonetheless, by using higher cutoffs stratified according to kidney dysfunction. NT-proBNP appears to predict heart failure better than BNP.

A framework for implementing best laboratory practices for non-integrated point of care tests in low resource settings.

The method we respond to pandemics is still inadequate for dealing with the point of care testing (POCT) requirements of the next large epidemic. The proposed framework highlights the importance of having defined policies and procedures in place for non-integrated POCT to protect patient safety. In the absence of a pathology laboratory, this paradigm may help in the supply of diagnostic services to low-resource centers. A review of the literature was used to construct this POCT framework for non-integrated and/or unconnected devices. It also sought professional advice from the Chemical Pathology faculty, quality assurance laboratory experts and international POCT experts from the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC). Our concept presents a comprehensive integrated and networked approach to POCT with direct and indirect clinical laboratory supervision, particularly for outpatient and inpatient care in low-resource health care settings.

Impact of COVID-19 on the pre and post analytical clinical laboratory testing processes- A performance evaluation study using six sigma.

BACKGROUND: The aim of this study was to determine the impact of COVID-19 pandemic on the total testing process using six sigma metrics based on a comparison of pre and during pandemic periods. MATERIAL & METHODS: The study duration was over 12 months, 6 months before and 6 months after the COVID-19 onset in Pakistan in March 2020 after the recognition of the first case, using quality indicators (QIs). QIs were chosen from a model of QIs recommended by the CAP. Analysis was performed using Six Sigma calculators and QIs were expressed in percentage (%) and Sigma value were computed. Three levels of performance quality i.e. 25th, 50th, and 75th percentile were derived, being best, common and worst performance respectively. Between-group differences were tested using the Mann-Whitney's U test. RESULTS: The median defect percentages of these QIs ranged from 0% to 0.27% for the pre-pandemic period and 0% to 0.13% for the during pandemic period. Meanwhile, sigma values of the majority of the QIs were all above 4.0σ during the pre and the pandemic times. For the pre-analytical phase, sigma scores declined for 1 QI, improved for 3 QIs and remained same for 2. In the post analytical phase, no change in sigma metrics was noted for critical values notification. Considerable increase in defect percentage of inappropriate turnaround times was noted. CONCLUSION: The emergency preparedness proved to be fruitful as depicted by exceptional performance on the sigma metrics for most Qis both prior to and during the pandemic. The pre-analytical and the post analytical phases, being the most error sensitive requires strict vigilance.

Pattern of drugs of abuse identified in chemical samples.

OBJECTIVE: To determine the pattern of drugs of abuse in urine and blood samples processed at referral laboratory in Pakistan so that information on the type of drugs used can be identified and used for ready reference for future strategy. STUDY DESIGN: Observational study. PLACE AND DURATION OF STUDY: Clinical Laboratory of The Aga Khan University Hospital, Karachi, from July 2006 to March 2008. METHODOLOGY: Retrospective review of records were done for the common drugs that are used for screening at the Clinical Laboratory include alcohol, amphetamine, barbiturates, benzodiazepines, cannabinoids, cocaine and opiates. Alcohol was tested in blood and others were identified using urine. Percentages of tests screened positive and negative for individual drugs were computed by using SPSS 16.0. The ratio between male and female users was also established. RESULTS: A total of 17,714 tests were performed for drugs. The mean age of the patients whose samples were processed was 30+/-14.84 years. Majority used benzodiazepines 520/1317 (39.5%) among the samples tested for drug of abuse, followed by cannabinoids 423/5450 (7.8%), alcohol 75/1302 (5.8%), barbiturates 32/1148 (2.8%), opiates 137/5640 (2.4%), cocaine 5/1655 (0.3%) and amphetamine 3/1202 (0.2%). In all, males 15411 (87%) were tested more frequently as compared to females 2303 (13%). CONCLUSION: Males were more frequently tested for drug abuse; however, drug abuse is increasingly seen among females. Benzodiazepines are the most frequently used. The same pattern of drugs abuse existed in different gender and age group. There is a need to explore the pattern and type of drug abuse on national scale.

Trend analysis of lab tests requisitions of COVID-19 prognostic biomarkers at a clinical chemistry reference laboratory-an observational study.

BACKGROUND: Biochemical parameters, such as C-reactive protein (C-RP), Procalcitonin (PCT), Lactate dehydrogenase (LDH) and Ferritin are associated with COVID-19 severity and prognosis. This trend analysis of COVID-19 prognostic biomarker requisitions is aimed at providing a reflection of the clinical practices adopted amidst the peak of the pandemic. This knowledge of the prognostic biomarkers utilized, will further aid to classify patients based on their risk, for optimal resource allocation and improve outcomes. MATERIAL & METHODS: This cross-sectional study was conducted at the clinical chemistry laboratory at the Aga Khan University Hospital (AKUH), Karachi Pakistan. A team consisting of two clinical chemistry consultants reviewed the COVID-19 prognostic biomarkers tests performance data from March to July 2020 using the integrated laboratory information management system (ILMS). The test statistics of March to July 2020 when COVID-19 cases were on the rise in the country were compared with those of the same months from 2019. The changes in the test groups were expressed in percentages. Microsoft Excel for windows 2019 was used for data analysis. RESULTS: The total specimens received for testing in 2020 (n = 574,092) showed a percent decline of approximately (-) 33% compared to 2019 (n = 858,756). Contrary to the overall decline in volumes an upward surge was noted for the prognostic biomarkers. From March to July, the highest percent change was noted for LDH (+155.1%), followed by PCT (+66.7.1%), C-RP (+26.5%) and Ferritin (+22.1%) in 2020 compared to the same time frame in 2019. The highest percent change was noted in June. CONCLUSION: During the COVID 19 pandemic, a significant increase in utilization of laboratory services was seen for COVID-19 prognostic markers.

Challenges amid COVID-19 times - Review of the changing practices in a clinical chemistry laboratory from a developing country.

Corona Virus Disease 2019 (COVID-19) pandemic is the defining global health crisis of our time. Compared with its neighbors China and Iran, which were rated as epi-centers of the outbreak, Pakistan has lower standards of health care, unstable economy and dearth of financial resources to tackle the outbreak. Like other institutes and industries in the country, clinical laboratories were succumbed to a variety of challenges. This article is based on the experience and adapted workflow measures from the Clinical Chemistry laboratory at the Aga Khan University Hospital (AKUH), Karachi, which serves as a national referral center with its widespread network of satellite laboratories and phlebotomy centers across the country. It highlights the challenges faced and the appropriate responses to ensure the provision of diagnostic facilities during the COVID-19 outbreak. Furthermore, the lessons acquired and necessary preparations for the post crisis situation are also incorporated.

Diagnostic efficacy of 0, 30, 45, 60, 90 and 120 min growth hormone samples in insulin tolerance test: utility of growth hormone measurement at different time-points and a cost-effective analysis.

OBJECTIVE: To determine the utility of growth hormone (GH) measurement with the insulin tolerance test (ITT), and to carry out a cost-effective analysis of the diagnosis of GH deficiency. MATERIAL AND METHODS: Ninety-nine patients clinically suspected of GH deficiency were evaluated over a period of 14 months (January 2005 to April 2006). Post-insulin samples of GH and blood glucose (BG) samples were drawn at six different time-points. Serum GH levels of <10 microg/L (prepubertal) and <6.1 microg/L (adolescents) were taken as cut-off for the normal response. RESULTS: Ninety-nine ITTs were carried out during the study period, and GH levels were found to be deficient in 47 subjects. Specificities at different time-points were 0%, 54%, 77%, 62%, 39% and 23% for 0, 30, 45, 60, 90 and 120 min, respectively, in the prepubertal group, and 5%, 41%, 80%, 87%, 77% and 46% at the same time-points for the adolescent group. Accuracy was highest at 45 and 60 min in both the prepubertal and adolescent groups. The receiver operating characteristic curve showed that the highest area under the curve was found in samples drawn at 45, 60 and 90 min in both the prepubertal and adolescent groups. CONCLUSION: Our data suggest that 0, 45, 60 and 90 min samples are sufficient for diagnosing GH deficiency, which could lead to potential cost reductions of up to 29.8%.

Oral iron chelation therapy with deferiprone in patients with Thalassemia Major.

OBJECTIVE: To determine the efficacy and adverse effects of deferiprone in patients with Thalassemia Major. METHODS: A prospective case series study was conducted at the Fatimid Foundation Blood Bank and Haematological Diseases center Lahore. A total of 87 patients entered into the study between September 2005 and November 2006. Deferiprone was given at subsidized rates at a dose of 75/mg/day for seven days. Physical examination and initial Laboratory investigations were done in all patients at the start of the study. Physical and laboratory data were filled on a questionnaire and analyzed using SPSS version 10.0. RESULTS: Eighty seven patients with mean age of 10.0 +/- 4.33 years (range 4-27 years) were included in the study. Mean follow up was 8 +/- 3.94 months (range 2-12 months). The mean Ferritin at the start of study was 4656 +/- 2052.5 ug/L (range 1200-14630 ug/L) and at the end of study period was 4139 +/- 1710.4 ug/L (range 749-8961) (p < 0.001). Adverse events were joint pains in 10% patients, gastrointestinal symptoms in 11% and no adverse events in 79% patients. There was no evidence of agranulocytosis in any patient. CONCLUSION: Deferiprone was well tolerated, had few adverse effects and was effective in lowering the patient's serum ferritin level.

The utility of neutrophil gelatinase-associated Lipocalin (NGAL) as a marker of acute kidney injury (AKI) in critically ill patients.

In current clinical practice, Serum Creatinine (SCr) is a commonly used marker for the diagnosis of acute kidney injury (AKI). Unfortunately, due to a delayed increase in SCr, it is unable to accurately estimate the timing of the injury. The purpose of this study was to assess the ability of plasma neutrophil gelatinase-associated lipocalin (pNGAL) to predict AKI in critically ill adult patients. The study was conducted at the Section of Chemical Pathology, Department of Pathology& Laboratory Medicine in collaboration with Department of Anesthesiology, at Aga Khan University Hospital in Karachi, Pakistan. Subjects in the age groups of18 to 60, that were admitted into the intensive care unit (ICU) with suspected sepsis were enrolled in this study.AKI was labeled by using Risk-Injury-Failure-loss-End Stage (RIFLE) criteria. Forty-eight patients, mean age being 46.5 ± 16.3, were recruited over a nine-month period. Multiple blood samples were collected from each patient at 12 h, 24 h, and 48 h. A total of 52.1% (n = 24) of ICU patients suspected of sepsis had developed AKI. Baseline characteristics of subjects with AKI were compared to those without AKI. Statistically significant difference was noted in gender (p-value< 0.05) and pNGAL (p-value< 0.001). However, no significant differences were seen with respect to age, in patients with and without AKI. The area under the curve (AUC) at12hr was 0.82 (95% CI 0.68-0.96) with a sensitivity of 70.8% and specificity of 90.9%.While AUCs at 24 h was 0.86(95% CI 0.74-0.97) with a sensitivity of 78.5% and specificity of 88.8%. Furthermore, there was a positive correlation between pNGAL and the length of ICU stay (r = 0.98). Non-survivors or expired patients had higher median pNGAL170 (202-117) ng/ml as compared to survivors 123(170-91) ng/ml. In conclusion, pNGAL is an early predictor of AKI in a heterogeneous adult ICU population. Plasma NGAL allows the diagnosis of AKI 48 h prior to a clinical diagnosis based on RIFLE criteria. Early identification of high-risk AKI in patients may allow earlier initiation of therapies and improve patient outcome.

Prospective evaluation of serum procalcitonin in critically ill patients with suspected sepsis- experience from a tertiary care hospital in Pakistan.

BACKGROUND: Sepsis is the leading cause of mortality in critically ill patients. Procalcitonin (PCT) is a promising marker for identification of bacterial sepsis. The aim of this study was to determine the diagnostic accuracy of serum PCT concentration in patients with suspected sepsis admitted to mixed medical-surgical Intensive care unit (ICU). MATERIAL AND METHODS: A cross-sectional study conducted at section of Chemical Pathology, Department of Pathology and Laboratory Medicine and ICU. Patients with suspected sepsis were included, serum PCT cut off ≥0.5 ng/ml was taken for diagnosing sepsis. Diagnostic accuracy was measured in terms of sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) taking blood culture as gold standard. Furthermore, different cut offs were compared by using receiver operating characteristic curves (ROC). Data analysis was done on SPSS version 20. RESULTS: Median age of the study group (n = 103) was 48 years (IQR: 22), 60% being males. Out of the 103 patients included 82 patients had PCT levels above the optimal cut off. At a serum PCT cutoff of 0.5 µg/L, the sensitivity and specificity for the diagnosis of sepsis was found to be 93.75% and 43.59% respectively. NPV was higher compared to PPV making PCT a reliable marker to for the screening out of sepsis patients. Furthermore, it was revealed that PCT having an AUC = 0.70 outperformed WBC (AUC = 0.5) and CRP (AUC = 0.6). CONCLUSION: Elevated PCT concentration is a promising indicator of sepsis in newly admitted critically ill patients capable of complementing clinical signs and routine laboratory parameters.

Anion gap among patients of multiple myeloma and normal individuals.

OBJECTIVE: To compare the Anion gap between patients of multiple myeloma and normal individuals presenting at a tertiary care hospital. DESIGN AND METHODS: This is a matched case-control study conducted at Aga Khan University Hospital, Karachi, from July 10, 2004 to April 30, 2006. The anion gap (AG) from the medical records of the 82 diagnosed cases of multiple myeloma (MM) and 104 controls were compared. Immunoglobulins (IgG and IgA) were measured by array nephelometric assay. Staging for MM patients were performed based on Salmon-Durie method. AGs were compared by independent sample t-test. Pearson coefficient of correlation was used to correlate paraprotein IgG concentration and anion gap. RESULTS: : Of the 186 study subjects (82 cases and 104 controls), 70% were males and 30% were females. The mean ages of MM and controls were 59.68+/-11.94 and 60+/-9.2 years respectively. There was a significant difference in mean AG, 11.2+/-1.7 mmol/L in control group (p<0.001) compared to 6.8+/-4.6 mmol/L for IgG MM and 8.4+/-4.37 mmol/L for IgA MM patients. Multiple myeloma patients stratified by clinical stages had anion gap of 8.7+/-1.7 in stage I, 7.93+/-0.47 in stage II and 5.65+/-0.31 in stage III. A significant correlation was found in IgG myeloma when anion gap was expressed as a function of the serum monoclonal protein concentration. CONCLUSION: The anion gap is significantly lower in multiple myeloma patients compared to controls. Lowered anion gap is more specific feature of the IgG type MM. We suggest that correlation of AG with the disease severity and with paraproteins concentration could potentially be useful in monitoring patients for disease progression. However, longitudinal studies are required to confirm the utility of anion gap in monitoring patients with MM.

Comparision between bed side testing of blood glucose by glucometer vs centralized testing in a tertiary care hospital.

BACKGROUND: To determine the accuracy, turnaround time and cost effectiveness of bedside monitoring of blood glucose levels by non-laboratory health care workers and centralized testing of blood glucose by automated analyzer in a tertiary care hospital. METHODS: The study was conducted in Section of Chemical Pathology, Department of Pathology and Microbiology and Section of Endocrinology Department of Medicine, Aga Khan University and Hospital Karachi, from April 2005 to March 2006. One hundred and ten patients were included in the study. The blood glucose levels were analyzed on glucometer (Precision Abbott) by finger stick, using Biosensor Technology. At the same time venous blood was obtained to analyze glucose in clinical laboratory on automated analyzer (SYNCHRON CX7) by glucose oxidase method. RESULTS: We observed good correlation between bed side glucometer and laboratory automated analyzer for glucose values between 3.3 mmol/L (60 mg/dl) and 16.7 (300 mg/dl). A significant difference was observed for glucose values less than 3.3 mmol/L (p = 0.002) and glucose values more than 16.67 mmol/l (p = 0.049). Mean Turnaround time for glucometer and automated analyzer were 0.08 hours and 2.49 hours respectively. The cost of glucose testing with glucometer was 48.8% lower than centralized lab based testing. CONCLUSION: Bedside glucometer testing, though less expensive does not have good accuracy in acutely ill patient with either very high or very low blood glucose levels.