Hemodialysis patients are at prone for essential trace element deficiency and accumulation of excess harmful trace elements, together of which can affect health burden. During dialysis required renal functions, such as the removal of metabolic waste products, water, correction of the acid-base status and electrolytes are substituted by the artificial purification system. Prone for both accumulation and deficiency of trace elements depends on removal by dialysis, dietary intake, the content of the source water used for dialysis and residual kidney function. This study aimed to evaluate the possible changes in serum iron (Fe) and zinc (Zn) levels in CRF patients undergoing dialysis, pre, and post. It is a case-control hospital-based study (n = 90), Patients included in the present study were all admitted to the Nephrology unit or attending the outpatient department of Nephrology and Dialysis ward. Group IA- Pre-hemodialysis, Group IB- Post-haemodialysis, Group II- Normal healthy controls. Results showed serum zinc levels in both groups of CRF patients (IA, IB) were significantly higher when compared to controls. There was a significantly higher serum level of iron in Group-IB when compared to Group-1A patients. To conclude, the present study has observed significant changes in zinc and iron in CRF patients, pre- and post-hemodialysis.

Aim: In the era of automation, the modalities available for analysis of samples for a clinical chemistry laboratory include both wet chemistry and dry chemistry analyzers. Wet chemistry systems are routinely used in small to large clinical chemistry laboratories whereas dry chemistry analyzers are restricted to large laboratories. Cost analysis is a system that is used for providing financial information to make financial projections. Aim of the study was to compare the cost analysis of wet chemistry and a dry chemistry analyzer. Materials and methods: Apart from the cost of the basic kits, a large number of controls, calibrators, consumables, and fluids are procured to run the various tests in the laboratories. A cost analysis of the wet chemistry analyzer and the dry chemistry analyzer available with us was performed to compare both the systems. Results: The cost per test (CPT) of the parameters on the wet chemistry analyzer was lower as compared to the dry chemistry analyzer. On factoring the cost of controls, calibrators, tubings, accessories and other consumables for both the systems, a figure of ₹ 8.91 as the cost of consumables per test for the wet chemistry analyzers and ₹ 0.40 for the dry chemistry analyzer was reached. On the further calculation of the cost per reproducible test (CPRT), it was seen that the wet chemistry analyzer had CPRT of ₹ 26.43 and the dry chemistry analyzer had ₹ 23.5. Conclusion: The results point towards the dry chemistry analyzer as being cheaper to a wet chemistry analyzer if the workload of samples being analyzed on them is high. Clinical importance: A thorough cost analysis is imperative to be done for any clinical chemistry laboratory to determine the cost-effectiveness of a system so that an informed decision can be made to incorporate new methods if required.

Introduction: Ovarian cancer is the third leading site of cancer among women in India. 70% of ovarian cancers are diagnosed with advanced disease leading to high fatality rate. Human epididymis protein 4 (HE4), also known as WAP four disulphide core 2 (WFDC2), is a novel protein and is one of the more promising biomarkers for improving diagnostic performance in ovarian cancer detection. Aim: To evaluate a new tumor marker, HE4, in comparison with CA-125 in diagnosis of ovarian cancer and benign gynecological diseases. Material and Methods: Pre-operative serum HE4 and CA-125 were determined in 146 patients with benign gynecologic diseases and 100 patients with malignant gynecologic cancers (64 were epithelial ovarian cancers patients). HE4 and CA-125 cutoffs were 140 pmol/L and 35 kU/L, respectively. Sandwich Elisa, biotin-labelled antibody kit was used for HE4. Results: HE4 demonstrated better specificity than CA 125 in benign gynecologic disease patients, with abnormal concentrations in 1.3% and 33.6% , respectively. A significantly higher area under the ROC curve was obtained with HE4 than with CA 125 in the differential diagnosis of gynecologic diseases (0.875 vs 0.723; p=0.0001). Both markers were clearly related to stage (HE4:p=0.004; CA-125: p=0.001).) and histopathological type (HE4: p =0.003 and CA-125:p =0.009 in serous papillary ovarian cancer). Conclusion: HE4 has significantly higher diagnostic specificity than CA 125, and the combination of CA-125 and HE4 improved the detection of ovarian cancer in all stages and histological types. HE4 use may be important in the differential diagnosis of ovarian cancer.

Aims: The aim of the study was to show a simultaneous increase of high sensitive C-reactive protein (hs-CRP) with a degree of renal involvement suggested by albumin-creatinine ratio and dyslipidemia in diabetic patients, as the period of diabetes progresses. No such duration based study has ever been conducted so far in the sub-Himalayan region and fringe area including different ecosystem as in the present study. Materials and methods: It was an Institution based observational comparative study conducted in a tertiary care hospital in sub-Himalayan belt from April 2016 to March 2017 among 120 diabetic individuals aged (30–60) years irrespective of gender, divided into 3 groups of 40 subjects in each, namely: (a) newly diagnosed <5 years, (b) 5–10 years after diagnosis and, (c) ≥10 years after diagnosis. Research variables were hs-CRP, urinary ACR and lipid profile. Results: Descriptive studies showed that mean values of hs-CRP were 0.04 ± 0.005, 0.08 ± 0.011, and 0.10 ± 0.017 and that of ACR were 100.29 ± 11.59, 117.65 ± 6.93 and 128.80 ± 7.91 in groups 1, 2, 3, respectively. One-way analysis of variance (ANOVA) with post hoc analysis after Bonferroni correction between different groups enunciated that both hs-CRP and ACR increased significantly and statistically (p <0.001) with a duration of diabetes in all three groups unlike the parameters of lipid profile. Hs-CRP, ACR, cholesterol and LDL even illustrated a very significant correlation between each other (p <0.001) whereas TG and HDL have shown correlations neither to themselves nor other parameters. Conclusion: Early detection, monitoring of inflammatory markers hs-CRP and ACR as predictors of diabetic nephropathy can help in modulating diabetes and its complications.

Introduction: Antinuclear antibodies (ANA) are the most commonly evaluated non specific autoantibodies in clinical practice. Previous studies showed ANAs are frequently detected in healthy individuals and expression of ANAs are more common in women and older age groups. To explain the reason of sex differences differential chromosomal, hormonal and reproductive factors are postulated, but till now the association is not clearly understood. There is paucity of Indian data of ANA status amongst women. In this study we examined the relationship of ANA status with socio demographic and reproductive factors in a representative sample of non pregnant adult Indian women. Aims and Objectives: • Estimation of ANA status prevalence in non pregnant Indian women by enzyme linked immunosorbent assay (ELISA) technique. • Effects of socio demographic and reproductive factors with ANA prevalence. Materials and methods: This study was conducted in the zonal level hospital. Non pregnant adult women who had ever menstruated and voluntarily completed the socio demographic and reproductive history questionnaire were included in the study. Serum ANA screening test were performed for the detection of IgG class antibodies to ANA in human serum by ELISA. Results: We analyzed data on socio demographic and reproductive factors in relation to serum ANA status in adult non pregnant females using SPSS statistical software. The values thus obtained statistically similar with those obtained in developed countries. Conclusion: These findings highlight the importance of considering sociodemographic and reproductive history in studies of autoimmunity in women in Indian set up.

Objective: Magnesium (Mg) plays a crucial role in vitamin D synthesis and metabolism. In magnesium-dependent vitamin-D-resistant rickets supplementation of this micronutrient changed the resistance to vitamin D treatment significantly. This study aims to evaluate the correlation between serum Mg and vitamin D total levels in an otherwise healthy individual. We hypothesized that in hypovitaminosis D, there is also a Hypomagnesaemia as well. Materials and methods: The study population comprises of 252 young patients, aged between 18 years and 45 years, consisting of individuals with and without hypovitaminosis D. The correlation between measured serum 25 hydroxyvitamin D total (25(OH) D) magnesium and calcium level concentrations were studied. Results: The mean age of the studied population was 31.5 ± 2.32 years, and studied groups, i.e. those with hypovitaminosis D and those without it were age matched. The mean 25 OH Vitamin D Total, Ca, and Mg level in the total study population was 20.32 ± 6.84 ng/mL, 9.6 ± 0.52 mg/dL, 2.24 ± 0.22 mg/dL, respectively. The mean serum 25(OH) D level was 23.62±2.12 in vitamin D insufficient group; however, it was 14.84 ± 2.74 in vitamin D deficient cases. The mean serum Mg level was 2.27±0.18 mg/dL in the vitamin D insufficient group, and it was 2.23 ± 0.25 in the vitamin D deficient group. Conclusion: In our study, we have demonstrated that there is no statistically significant associations exist between measured serum Mg and 25(OH) total vitamin D levels. Level of vitamin D and serum Mg is independent of each other and taking vit D alone is sufficient enough to combat hypovitaminosis D. However, further large longitudinal studies are desirable to evaluate the causal mechanisms and the clinical connotation of the current findings.

The advantage of Accreditation is quality test reports and customer satisfaction. Technicians are integral part of medical testing laboratories. So they should have commitment towards acquiring and updating sound knowledge about good laboratory practices. Aim: To assess the impact of accreditation on awareness and knowledge of technician’s about laboratory quality measures in tertiary care hospital. Material and Method: We prepared a questionnaire based on quality management system (QMS), Pre-Analytical, Analytical, Post-analytical examination and laboratory safety. Total thirty technicians appeared for pretest before accreditation, followed by various training sessions and NABL accreditation. A post test was conducted after accreditation for the same. Result: The data of pretest and post-test performance was analyzed by SPSS software. The result shows there was significant (p < 0.001) increase in the score of the marks among technicians in post-test (20.67±3.67) compared to pre-test (10.21 ±4.39). Conclusion: In present study we observed suboptimal knowledge & awareness in technicians regarding QMS. This was found enhanced after Accreditation process & continuous training sessions. This will be helpful to improve their skill to sustain quality laboratory services.

Introduction: PIH is one of the most common causes of both maternal and neonatal morbidity. Endothelial dysfunction (ED) is a classic hallmark for PE. The mechanisms involved in the induction of ED are poorly understood. The disorders in lipoprotein metabolism are one of the most important causes for ED. AIP is another risk factor calculated by log (triglyceride/HDL-c) which is an indicator of atherosclerosis. The role of Lp(a) in atherosclerosis and its ability to induce thrombosis makes it important in normal and complicated pregnancies. So, a study has been designed to analyse the levels of Lp(a), Atherogenic index of plasma (AIP), and Nitric oxide (NO) in PIH women. Materials & Methods: A cross-sectional analytical study involved normotensive, PE & E pregnant women with 100 subjects in each group. They were investigated for serum Lp(a), NO in the 3rd trimester of pregnancy. Lp(a) was estimated by commercial kit method, NO was measured by Griess method and AIP was calculated by standard formula log (triglyceride/HDL-c). Results: The systolic blood pressure (SBP), diastolic blood pressure (DBP), AIP were significantly high and NO levels were significantly low between 3 groups. The Lp(a) levels were significantly high in PE than controls. The Lp(a) and AIP were negatively correlated with NO. Conclusion: Lp(a) and AIP are indicators to predict endothelial dysfunction in preeclampsia and eclampsia subjects. AIP may be better predicable indicator than Lp(a), since it was significantly raised in both PE and E.

Introduction: Polycystic ovary syndrome (PCOS) affects 5–10% of women in reproductive age. It is associated with metabolic syndromes and non-metabolic disorders. Women with PCOS have dyslipidemia and oxidative stress representated by elevated serum Malonaldehyde (MDA) levels. These features are risk factors for development of atherogenesis and cardiovascular disease (CVD). Materials and methods: A case-control study was conducted at the Department of Biochemistry, Koppal Institute of Medical Sciences, Koppal, India. It included 100 diagnosed PCOS patients (50- obese and 50 non-obese) and 100 controls (50-obese and 50 non-obese) in the age group of 18-40 years. The mean±SD were compared using student‘t’ – Test from the SPSS Statistics Data Editor version 21. Kruskal–Wallis test was employed for p values. The p value of <0.05 is considered statistically significant. Results: Serum levels of total cholesterol, serum triglyceride, LDL, VLDL were higher in women with PCOS irrespective of BMI with p value of <0.001.There were low levels of serum HDL in women with PCOS irrespective of BMI with p value of <0.001. Serum MDA levels were higher in women with PCOS irrespective of BMI with p value of <0.001. Conclusion: Dyslipidemia and increased OS indicated by elevated levels of MDA are seen in women with PCOS irrespective of BMI. Hence, PCOS women should be evaluated for lipid profile and oxidative stress and should be treated with antioxidant supplementation, which can be beneficial in preventing coronary vascular diseases.

Background: Ischemia modified albumin, IMA is albumin which has altered in its amino terminal due to ischemia, following which, it loses its capacity to bind to metal cations like cobalt ions. It is also a candidate marker of oxidative stress. Normal pregnancy is associated with production of free radicals compared to non-pregnant women. Materials and methods: In this prospective study, the IMA and IMA albumin ratio levels of 40 pregnant women with pregnancy induced hypertension of age group 18–40 years were compared with the 40 age matched healthy pregnant controls. The albumin cobalt-binding test was used to estimate the IMA levels and serum albumin levels were estimated using absorbance by Bromocresol green. Results: Mean levels of IMA were higher in the case group as compared to control group (0.52 ±0.1 ABSU vs 0.04 ± 0.03 ABSU, p <0.05). The albumin levels were lower in the patients’ group compared to the controls’ group and the difference was statistically significant (p <0.05). The ratio of IMA to normal serum albumin (IMAR) was higher in the patients’ group than the controls group (p <0.05). Conclusion: Ischemia modified albumin and the ratio of IMA to normal serum albumin are significantly elevated in hypertensive disorders of pregnancy as compared to normal healthy pregnant controls and therefore are useful biomarkers of pregnancy induced hypertension.

Background: Hypothyroidism is one of the most commonly occurring endocrine disorders, worldwide. The disorder is associated with a wide range of muscular involvement varying from myalgia to true myopathy. Biochemical parameters such as serum Creatine Kinase (CK), a sensitive marker of muscle damage and serum Lactate Dehydrogenase (LDH), a general marker of tissue damage can be measured to assess the muscular involvement in hypothyroidism. In this study serum CK and LDH activities to assess the muscular involvement in hypothyroidism and to evaluate their relationship with T₃, T₄ and TSH. Materials and methods: Fifty, clinically diagnosed hypothyroidism patients with symptoms suggestive of muscle involvement were taken as cases and fifty sex and age matched, apparently healthy volunteers with normal thyroid function tests (TFT) were taken as controls. Biochemical estimations of triiodothyronine (T₃), thyroxine (T₄), thyroid stimulating hormone (TSH), serum CK and serum LDH were done. Results: T₃, T₄ levels and serum CK and LDH activities were within the reference range in both the study groups. In seven cases high TSH with low T₄ values were observed. Significant difference in serum CK and LDH activities were observed in these seven cases compared to rest of the forty-three cases. Even though there was no significant difference among the study groups (cases and controls), a weak positive correlation of CK, LDH with TSH levels and weak negative correlation with T₃ and T₄ levels were observed. Conclusion: Hormone replacement therapy shall be optimized to treat muscular involvement if serum CK and LDH activity is found to be elevated with low T₄ levels, where as normal serum CK and LDH activity with normal T₄ levels indicates that the thyroid treatment is optimized (serum T₃ and T₄ levels has come to the reference range though TSH is mildly elevated) and if the subject is still complaining of muscular symptoms, then other underlying causes for muscular involvement shall be ruled out.

Background: Postpartum persistent proteinuria and hypertension (HT) is associated with development of chronic kidney disease and cardiovascular disease in later life. AIMS & OBJECTIVES: To evaluate blood pressure, proteinuria and serum NT-pro-BNP in proteinuric preeclamptic (PE) women and study their postpartum resolution till 3 months and determine the associated risk factors. Material and Methods: 100 PE women enrolled included 66 women with mild (group A) and 34 with severe PE (group B). BP, urinary protein:creatinine(P/C) ratio, S.NT-pro-BNP were evaluated at labor room admission, postpartum day 1, 6 weeks and 3 months. Results: Group B women had significant higher baseline BP, urine P/C ratio and S. NT-pro-BNP compared to group A. Resolution of BP, proteinuria and S. NT-pro-BNP was complete in group A women at 6 weeks postpartum. Persistent hypertension was observed in 25 and 4 women at postpartum 6 weeks and 3 months respectively. Proteinuria persisted in 25 and 10 women at postpartum 6 weeks and 3 months respectively. Resolution of NT-pro-BNP was complete at 3 months. In logistic regression model persisting hypertension and proteinuria at 3 months was correlated with increasing age, higher BMI and lower gestational age at delivery. Negative predictive value of 100% was observed with baseline P/C ratio <5, BP <120 mm Hg diastolic and S.NT-pro-BNP <1000 pg/mL for development of persistent proteinuria and hypertension. Conclusion: Women with severe PE should be followed up for persistent proteinuria and hypertension. These women require evaluation for chronic kidney disease and preventive strategies for cardiovascular disease.

Background: Turnaround time (TAT) is one of the most noticeable signs of a laboratory service and is used by many clinicians as a benchmark to judge the quality of laboratory service. Despite automation and computerisation, delayed TAT of emergency department (ED) samples was a complaint received in our clinical biochemistry laboratory. After process mapping and root cause analysis, we designed an improvement strategy which included the introduction of emergency request forms (ERF), creating awareness in the technical staff by proper training and streamlining the work flow path. Aim: To compare the TAT of ED samples for electrolytes, received 1month before and after implementing the process improvement strategy. Materials and methods: Data regarding the number of electrolyte assays ordered from ED for 1 month before and after implementing the improvement strategy was obtained from hospital laboratory information system (LIS). TAT was calculated as the interval between sample accession in the laboratory and the time results were reported in LIS. Independent sample ‘t’ test was used to compare the mean TAT before and after the intervention Results: Independent sample ‘t’ test showed reduction in the TAT of ED electrolyte assays after intervention compared to before intervention (78.74 and 110.08 min respectively) with a statistically significant (p<0.001) difference of 31.34 min. Conclusion: Significant reduction in the TAT of ED samples after intervention highlighted the power of analytical phase intervention in the form of reallocation of resources and staff awareness in effectively reducing the TAT. The study also proved the usefulness of having separate colour coded ERF in early identification, segregation and processing of ED samples. Clinical Significance: Decreased laboratory turnaround time of ED investigations is clinically significant because along with customer satisfaction it also improves the efficiency of work by allowing the early diagnosis, treatment, patient discharge and provides a way of cost cutting.

Aim: To determine serum cystatin C (CysC) levels in metabolic syndrome (MetS )patients and correlation of cystatin C with individual components of MetS. Materials methods: A cross-sectional study included 100 cases of MetS and 50 controls. One hundred cases were further divided into 3 groups depending upon the number of components of MetS. Anthropometric parameters like height, weight, BMI (body mass index), Waist circumference were measured. Fasting plasma glucose,serum total cholesterol, serum triglycerides, serum HDL (high density lipoprotein), LDL(low density lipoprotein), VLDL (very low density lipoprotein), systolic blood pressure (SBP) and diastolic blood pressure(DBP), creatinine, urea, eGFR (estimated glomerular filtration rate) and CysC were measured in each individual. Correlation of CysC with each component of Mets was studied. Results: CysC was significantly increased in MetS patients than in controls. Level of serum CysC was increased with an increase in components of MetS. CysC was positively correlated with waist circumference, fasting plasma glucose, triglycerides, SBP, and DBP and negatively correlated with HDL. There was no significant difference in urea, creatinine, and eGFR in studied groups. Conclusion: CysC is significantly correlated with individual components of MetS.CysC may be used as an early marker of renal dysfunction in MetS patients.

Cancer is one of the leading causes of death in both economically developed and developing countries. Among all the cancers, hepatocellular carcinoma (HCC) was a significant contributor being the fifth most prevalent and third leading global cause of deaths related to cancer. The most common biomarker use in its detection is Alpha-fetoprotein (AFP), but it has low sensitivity and specificity. Many other biomarkers have been evaluated for HCC detection, of which Protein Induced by Vitamin K Absence-II (PIVKA-II) is one, that showed elevated levels in these patients. So, we tried to evaluate the role of PIVKA-II in diagnosing HCC and its usefulness in differentiating HCC and Hepatic Cirrhosis (HC). The study group consisted of 70 patients with liver disease- 35 with HCC, 35 with cirrhosis; and 20 healthy study subjects who were age and gender matched. All patients and healthy subjects were evaluated for serum levels of both PIVKA-II and AFP. The median serum concentration of PIVKA-II in HCC, HC patients and healthy subjects were found to be 40.37 (23.3–79.38) ng/mL, 2.33 (1.03–3.72) ng/mL and 2.27 (0.12–12.87) ng/mL, respectively. To assess diagnostic utility, Receiver operating characteristic (ROC) curves plotted for both PIVKA-II and AFP. At a cut-off level of 6.715 ng/mL, PIVKA-II showed 85.71% sensitivity and 95.0% specificity, whereas AFP at a cut-off level of 11.8 ng/mL showed 77.14% sensitivity and 95% specificity. When both combined, their sensitivity increased to 94.29%. Also, there was a positive correlation of PIVKA-II levels with tumor size (p = 0.043), while no such significant association was found with AFP. Therefore, our study concludes that PIVKA-II is more sensitive than AFP in diagnosing HCC and differentiating it from Hepatic Cirrhosis; and when both combined, the sensitivity increased. Also, the positive correlation of Tumour size with PIVKA-II levels indicates that it may be useful in monitoring patients for progression of HCC.

Background: Chronic kidney disease (CKD) is a present world health problem. It is widely accepted that uremia, depresses the immunity and make them most susceptible to infection. The relationship between uremia, impaired immune status, and susceptibility to infection has never been established. Aim: The study was designed to know the association between levels of immunoglobulins and inflammatory marker hs-CRP in various stages of CKD patients and comparing it with healthy controls. Materials and methods: One hundred twenty-one CKD patients staged based on eGFR were evaluated for serum Immunoglobulins (G, A&M), hs-CRP and compared between the different stages and also with healthy controls (n = 24). Results: Out of 121CKD patients (male = 88, female = 33) with a mean age of 46 ± 15 years, known cases of hypertension (HTN) were seen in 32%, both DM and HTN 38%, DM only in 1% and remaining were with no h/o DM or HTN. The median levels of blood urea, serum creatinine, and hs-CRP are significantly high across the CKD stages and when compared to healthy controls (p <0.0001). IgM levels showed significant (p = 0.0005) decrease across all the stages of CKD, whereas IgG levels have decreased trend across the stages but statistically not significant. Conclusion: Based on our findings it can be concluded that a deficiency of immunoglobulins was noticed in a considerable number of uremic patients from all stages of CKD, suggesting inhibition of their synthesis by the uremic state. Uremic patient is associated with a state of immune dysfunction characterized by immunodepression that leads to a high prevalence of infections, and also by immunoactivation causing inflammation (increase in hsCRP).