Manickam Tamil Selvi , Srinivas Ankanagari,
Volume 13, Issue 1 (1-2019)
Abstract
ABSTRACT
Background and Objectives: Implementing quality management system (QMS) in medical laboratories improves quality of procedures and enhances the staff’s skill development. It prevents frequent inaccuracies in both clinical and laboratory procedures caused by lack of regulatory compliance, safety precautions and inadequate facilities. The purpose of this study is to evaluate effect of implementing QMS based on essential standards NABH (MLP) and NABL (ISO 15189:2012) in a medical laboratory on quality of services.
Methods: Important quality indicators such as external quality assurance services (EQAS), rework, turnaround time (TAT) and feedback were monitored for four months, following implementing the QMS standards in a medical laboratory.
Results: We found that implementation of the QMS program improved the tested indicators of quality. Overall percentage of rework reduced significantly.
Conclusion: Implementation of QMS improves overall quality of laboratory procedures. It significantly reduces laboratory errors and progressively improves quality, efficiency, and outcomes, thus enabling delivery of timely and accurate services for patients.
Keywords: ISO 15189, Quality Assurance, Quality Improvement, Accreditation, Clinical Chemistry, India.
Elaheh Rezaei , Pejvak Khaki , Soheila Moradi Bidhendi , Mojtaba Noofeli ,
Volume 13, Issue 1 (1-2019)
Abstract
ABSTRACT
Background and Objectives: Leptospirosis is a widespread zoonotic disease that is transmitted directly or indirectly from animals to humans. Humans mainly acquire pathogenic leptospires through mucosal or percutaneous exposure to environment contaminated with urine from an infected animal. We aimed to identify pathogenic leptospiral serovars by detection of the ompL37 gene using polymerase chain reaction (PCR).
Methods: Sixteen pathogenic leptospiral serovars and a saprophytic serovar, L. biflexa were cultured in modified semisolid Ellinghausen-McCullough-Johnson-Harris medium containing 5% rabbit serum. Genomic DNA extraction was done using the phenol-chlorophorm method. The ompL37 gene was amplified using specific primers. PCR products were analyzed by agarose gel electrophoresis.
Results: The ompL37 gene was amplified only in the pathogenic leptospiral serovars. We detected no amplified fragment for the saprophytic serovar.
Conclusion: Leptospirosis may be confused with other infectious diseases, and therefore, its early and accurate diagnosis is crucial. We showed that molecular detection of pathogenic leptospires based on the ompL37 gene could be used for laboratory diagnosis of leptospirosis.
Keywords: Leptospirosis, PCR, ompl37 Gene, Pathogenic Leptospires.
Nasir Idkaidek, Hiba Qawasmi, Alaa Hanahen, Luay Abuqatouseh, Salim Hamadi, Mona Bustami,
Volume 14, Issue 4 (7-2020)
Abstract
ABSTRACT
Background and Objectives: Proper diagnosis of clinical conditions is a major goal of clinical and biochemical analyses. Recently, increasing efforts have been put on the use of less invasive sampling techniques with optimal sensitivity and specificity. The aim of this study was to investigate the applicability of saliva instead of blood for measuring biochemical parameters of liver and kidney function in healthy individuals.
Methods: Plasma and saliva samples were collected from 100 healthy volunteers to measure level of alkaline phosphatase (ALP), alanine transaminase (ALT), aspartate aminotransferase (AST), total bilirubin, gamma-glutamyl transpeptidase (GGT), urea and creatinine using a fully automated chemistry analyzer (ACE Alera) with ready to use validated kits. Receiver operating characteristic (ROC) analysis was carried out using MediCal program to calculate sensitivity and specificity and area under ROC (AUC).
Results: The mean (standard deviation) salivary level of ALP, AST, ALT, GGT, total bilirubin, creatinine and urea was 20.9 (20.7) U/L, 25.8 (17.9) U/L, 10.6 (11.8) U/L, 9.6 (4.37) U/L, 0.16 (0.13) mg/dL, 0.09 (0.05) mg/dL and 35.6 (15.2) mg/dL, respectively. Saliva to blood ratios of ALP, AST, ALT, GGT, total bilirubin, creatinine and urea was 14%, 113%, 65%, 45%, 19%, 12% and 130%, respectively. The suggested normal saliva ranges of ALP, AST, ALT, GGT, total bilirubin, creatinine and urea were 7-98 (U/L), 31-104 (U/L), 6-31 (U/L), 15-24 (U/L), 0-0.13 (mg/ dL), 0.14-0.31 (mg/ dL) and 45-74 (mg/ dL), respectively. The calculated sensitivity and specificity values were 38% and 85% for ALP), 80% and 76% for AST, 75% and 45% for ALT, 60% 91% for GGT, 49% and 38% for total bilirubin, 20% and 91% for creatinine and 100% and 75% for urea. The AUC was higher than 0.7 for urea, GGT and AST, indicating good sensitivity and specificity of saliva testing for evaluation of these enzymes.
Conclusion: Based on the results, saliva could be as a noninvasive method of assessing kidney and liver function. Saliva may be a favorable alternative to plasma for measuring level of urea, GGT and AST in humans.
Puja Kumari Jha, Rachna Agarwal, Rafat Sultana Ahmed,
Volume 15, Issue 6 (11-2021)
Abstract
Background and objectives: Turnaround time (TAT) is an important quality indicator for benchmarking laboratory performance. Delay in TAT may affect patient safety; thus, continuous monitoring and analysis of laboratory workflow is mandatory. This study was designed to improve the TAT of two biochemistry laboratories serving in tertiary care teaching hospitals (multispecialty and super-specialty) through the application of quality tools namely quality failure reporting, the Fishbone model, and process mapping.
Methods: First, TAT was defined for routine (four hours) and urgent samples (two hours). Then, TAT failureincidents in 2018-2019 were analyzed using the Fishbone model. The process map of TAT was studied and made more value streamed and lean after removal of waste steps.Corrective action plans were prioritized and implemented for potential causes with more adverse outcomes. Pilot solutions were implemented for six months and TAT failures incidents were reanalyzed.
Results: The quality failure in TAT reporting was reduced by 22% (from 34% to 12%) for urgent samples and by 19% (from 27% to 8%) for routine samples after the implementation of quality tools in multispecialty hospital laboratory. In the super-specialty hospital laboratory, the improvement was more profound and the TAT percentage achieved after the corrective actions was 96.57% and 98% for urgent and routine samples, respectively.
Conclusion: Implementation of quality failure reporting culture along with quality tools led to significant improvement in TAT and higher quality laboratory performance in terms of efficiency, reliability, and increased patient safety.
Madhusudana Hn, Akriti Kashyap, Sunita Patil, Gurpuneet Basra, Navnath Dighe, Sashindran Vk,
Volume 16, Issue 3 (5-2022)
Abstract
Background and objectives: Intraoperative blood transfusion is a common medical intervention worldwide. Although mostly lifesaving when indicated, inappropriate administration of intraoperative can be potentially life-threatening. The aim of this study was to analyze the most common surgery/invasive procedures requiring intraoperative transfusion and to determine indications for intraoperative transfusion as well as the outcome of the patients after intraoperative transfusion.
Methods: A retrospective review of the electronic database of medical records was done for surgical patients who received intraoperative transfusion from June 2019 to December 2019. Preoperative hemoglobin values, associated comorbidities, and physiological triggers including hypotension and tachycardia were recorded. Descriptive statistics were used to summarize the data.
Results: A total of 36 patients (age range: 9-80 years) were studied. Orthopedic surgeries (53%) were the most common surgeries that required intraoperative transfusion. Preoperative anemia (hemoglobin <10 g/dl) was the predominant reason for intraoperative transfusion. Type 2 diabetes mellitus (36.3%) was the most frequent comorbidity among the cases of intraoperative transfusion. Half the cases received two units of packed red blood cell (pRBC), while 39% of the cases received one unit of pRBC. The remaining 11.1% received more than two units of pRBC. Furthermore, 77.7% of the patients were discharged to home within a week, while 16.6% of the patients were discharged after a prolonged hospital stay (> one week). The remaining 5.5% died in the hospital within a week of the procedure/surgery.
Conclusion: Transfusion practices vary among physicians, hospitals, and countries. The findings highlight that the hospital might be the most important determinant of the number of administered transfusions, with some adopting programs to reduce transfusions for elective surgery.
Mohammad Panji, Marzieh Ghafouri,
Volume 16, Issue 4 (7-2022)
Abstract
Background and objectives: Gastric ulcers occur when the mucous layer covering the gastric wall is damaged. Curcuma and licorice are famous ancient herbs that have been widely used as food additives and medicinal herbs. The present study aimed to investigate gastroprotective activity of Curcuma and licorice extract (CLE) against ethanol-induced gastric ulcers in male Wistar rats.
Methods: Fifteen male Wistar rats were randomly divided into five groups and fasted for 24 hours with free access to water. The rats received different doses of CLE (200 and 500 mg/kg) or omeprazole (20 mg/kg) by oral gavage. One hour after the induction of gastric ulcer via absolute ethanol administration (5 ml/kg), the rats were sacrificed, and the stomach was opened along the greater curvature. Ulcerative lesions were observed and counted. Total juice acidity was evaluated. Finally, mRNA level of Bax and COX-2 was measured.
Results: The oral administration of CLE (200 and 500 mg/kg) and omeprazole (positive control, 20 mg/kg) to rats remarkably attenuated gastric acidity and the number of ethanol-induced gastric lesions. Further examination of gastric mucosal homogenate revealed significant downregulation of Bax and COX-2 in the CLE-treated groups compared with the lesion control group.
Conclusion: The findings of this study confirm the gastroprotective activity of CLE against ethanol-induced gastric injury.
Karolyn Sassi Ogliari, Monica Luiza Immig, Maria Laura Halon, Fabrízio Loth, Luiza Boni, Patrícia Grudzinski, Liziane Beckenkamp, Martina Fritsch,
Volume 16, Issue 4 (7-2022)
Abstract
Background and objectives: Semen cryopreservation is widely used in assisted reproduction techniques, and reliable semen analysis is essential to define the clinical practice. However, many parameters used for semen evaluation have high variability among technicians. Here, we describe a method of validating semen analysis prior to cryopreservation, comparing each operator’s results with an expert, and also analyzing inter-operator variability. As a second endpoint, we compare this method by analyzing semen parameters before and after cryopreservation.
Methods: Four professional trainees studied and practiced semen analysis according to the World Health Organization guidelines for one month, under supervision of an expert in the field. Next, microscopic results (sperm concentration, motility, vitality, and morphology) obtained by each team member were compared with the findings obtained by the expert.. Finally, analyzes of inter-operators were evaluated for the same parameters.
Results: The findings obtained by the operators and the expert did not differ significantly. Furthermore, in the inter-operator analysis, the morphology parameter differed significantly in the fresh semen sample, which was not observed in the post-thaw sample.
Conclusion: Our results indicated that the laboratory staff training for semen analysis was effective, ensuring the assessment of individual performance and uniformity among operators in sperm count parameters, producing consistent results.
Negin Valizadeh Keshmeshtapeh, Dr Somayeh Namroodi, Dr Shohreh Taziki,
Volume 16, Issue 5 (9-2022)
Abstract
Background and objectives: Considering the increasing use of nanochitin for the removal of heavy metals from aqueous solutions, examining the biological effects of this substance on the level of essential metals for humans and animals is crucial. Therefore, this study investigated impact of oral administration of nanochitin on serum levels of iron (Fe) and calcium (Ca) in Wistar rats.
Methods: Twenty male Wistar rats were randomly divided into four treatment groups and one control group. Two groups were fed with nanochitin at doses of 1.6 and 2.6 μg/g for 6 weeks, and the other two groups received the mentioned doses for 10 weeks. Serum concentrations of Fe and Ca were measured using atomic absorption spectroscopy.
Results: Oral administration of 2.6 μg/g nanochitin for 10 weeks caused a significant decrease in serum Ca and Fe concentrations (p<0.05). Oral administration of 1.6 and 2.6 μg/g nanochitin for 6 weeks caused a non-significant reduction in serum Fe and Ca concentrations (p>0.05). However, nanochitin consumption for 10 weeks resulted in a significant decrease in serum Fe concentration but not Ca.
Conclusion: The limited reduction of serum Fe and Ca concentrations after oral consumption of nanochitin at a low dose and for a limited duration indicates that the controlled use of nanochitin could be safe for animals. However, complementary studies are needed to determine the exact effects of nanochitin on the animals’ bodies. On the other hand, it is recommended to use Fe and Ca supplements after consuming high doses of nanochitin for longer periods.
Maryam Yaseri, Seyyedeh Sahereh Mortazavi Khatibani, Arvin Naeimi, Haniyeh Sadat Fayazi,
Volume 16, Issue 6 (11-2022)
Abstract
Background and objectives: In coronavirus disease 2019 (COVID-19), elevated serum levels of C-reactive protein (CRP), a marker of systemic inflammation, are commonly observed. We aimed to investigate the associations between CRP test results and clinical characteristics in patients with COVID-19.
Method: In this cross-sectional study, data from 399 patients with COVID-19 were collected through a census method. The patients were divided into a CRP-positive group (n=335) and a CRP-negative group (n=64). Demographical data, laboratory findings, clinical characteristics, and history of some underlying diseases were compared between the two groups. All analyses were carried out in SPSS (version 21).
Results: The frequency of hypertension was 40.1% among the study population, 42.4 % among CRP-positive patients, and 28.1% among CRP-negative patients. Diabetes and heart disease were the most common comorbidities among the patients. Dyspnea (60.4%), fever (52.7%), fatigue (45.4%), and dry cough (40.1%) were the most commonly observed symptoms. The mean duration of hospitalization was 8.14±6.18 days, and the mean duration of intensive care unit stay was 9.09±9.41 days. Moreover, CRP positivity was significantly associated with hypertension, immunosuppressive therapy, and higher duration of hospitalization (p<0.05).
Conclusion: Pre-existing hypertension, diabetes, and heart disease with the coincidence of some clinical symptoms are associated with higher levels of CRP in COVID-19 patients, which results in longer hospitalization.
Jonas Bikorimana, Joselyne Ingabire, Aprinal Arinaitwe, Parfait Cyuzuzo,
Volume 17, Issue 1 (1-2023)
Abstract
Background and objectives: All three phases of laboratory testing are equally important for improving total quality management, but the pre-analytical phase is the most error-prone. This study aimed to determine the rate and reasons for blood sample rejection in the pre-analytical phase of laboratory testing in a referral hospital in Ruhengeri, Rwanda.
Methods: This study was a cross-sectional and retrospective study in which 222 samples with nonconformities were discovered from 19,775 clinical samples. Various data related to the rejected samples were recorded along with nonconformities.
Results: The rate of blood sample rejection was 1.045% and 1.165% for the cross-sectional and retrospective approaches, respectively. The overall blood sample rejection rate was 1.105%. The most frequent error in the cross-sectional aspect was mislabeling (38.3%), while clotting (46.4%) was the most common cause of sample rejection in the retrospective aspect.
Conclusion: Based on the results of our study, the rate of blood sample rejection is high in the study area. Thus, there should be a laboratory policy for error record keeping as well as a settlement in “laboratory sentinel events” covering the total testing process.
Gauri Metkar, Shalaka Saraf,
Volume 17, Issue 4 (7-2023)
Abstract
Gauri Metkar 
,
Shalaka Saraf
Background: Snakebite is a potentially life-threatening emergency that can be treated effectively. Snake envenomation can cause hematologic and coagulation abnormalities. In this respect, tests such as prothrombin time (PT), international normalized ratio (INR), and activated partial thromboplastin time (aPTT) are commonly used. The present study aimed to determine the value of coagulation parameters in the prognostication of snakebite patients.
Methods: This prospective descriptive observational study examined the coagulation parameters, including PT, INR, and aPTT, in consecutive cases of snake envenomation admitted to a tertiary health care hospital from October 2019 to August 2021. The correlation of coagulation parameters with each other and with prognostic indicators (ie, the number of days spent in the intensive care unit [ICU], the requirement of anti-snake venom [ASV], fresh frozen plasma [FFP], and the total number of blood products) was studied.
Results: A total of 58 patients with snakebite were studied. The majority were males (69%). The highest proportion of patients belonged to the age group of 16-40 years (60%). The correlation of coagulation parameters with each other was statistically significant. The correlation of coagulation parameters with prognostic indicators (ie, the total number of ASV vials administered, the total number of days in the ICU, the total number of FFP units administered, and the total number of blood components administered) was statistically significant.
Conclusion: Coagulation parameters (PT, INR, and aPTT) are essential laboratory investigations for treatment monitoring and can be used effectively for the prognostication of snakebite patients. In cases where the coagulation profile of snakebite patients shows abnormalities, conducting repeated coagulation studies at intervals of 12 hours can contribute to improved prognostication.
Ehsan Ameri, Ali Farhadi Mahali, Mojtaba Tabari,
Volume 17, Issue 4 (7-2023)
Abstract
Ehsan Ameri 1,
Ali Farhadi Mahali2 ,
Mojtaba Tabari3
Background: Improving the quality of visit services in laboratories of medical-teaching centers of universities of medical sciences plays a major role in providing better services to patients. The present study aimed to evaluate the policy of improving the quality of visit services of the reform plan in laboratories of medical-teaching centers in Golestan province.
Methods: The present research was cross-sectional and had a descriptive-analytical type. A total of 384 staff in the diagnostic laboratories were selected for the study using a simple random sampling method. The data collection tool included a 35-item researcher-made questionnaire.
Results: There was a gap between the current and desired status of the fourth axis of the health system reform plan. The gap was about -0.01, indicating that there was a gap between the current and desired status and it was related to the supervision department according to the respondents in the target statistical population.
Conclusion: The implementation of this plan was effective in improving the quality of visit services in laboratories of medical-teaching centers in Golestan province but this effectiveness did not meet the goals of the fourth axis of the reform plan. Therefore, the factors, which caused a lack of supervision among the executive departments of laboratories of medical-teaching centers in Golestan province, should be removed for increasing the effectiveness of this plan.
Merlin Matena, Gédéon N. Bongo, Honoré Ngbanda, Eddy B. Bakemo, Yves M. Mukaba, Jossard K. Munzumba, Justin M. Vuvu, Christel K. Kande, Jacques N. Ngayuna, Jonathan I. Kukila, Ngbolua Koto-Te-Nyiwa,
Volume 17, Issue 4 (7-2023)
Abstract
Background: COVID-19 is a viral infection caused by SARS-CoV-2, which enters the body via the ACE2 receptor. This study aims to evaluate the coagulation disorders of COVID-19 patients admitted to Centre Hospitalier Mère-Enfant Monkole, Kinshasa.
Methods: This descriptive cross-sectional hospital-based study of patient files was conducted between July 2020 and June 2021 at CHME-Monkole in Kinshasa. The sample size was 130 patients using a random sampling technique after interviewing the respondents. For each respondent, biological and socio-demographic data were collected on a questionnaire. The primary analyses included the determination of PT, APTT, Plasma determination of D-dimers, and platelet count. A descriptive analysis was performed for socio-demographic characteristics, while Pearson correlation was used to determine the associations between socio-demographic characteristics and different biological parameters using SPSS 25.0. For ethical reasons, informed consent from patients was sought, and confidentiality was assured. The authorization was provided by the Ethical Committee of CHME-Monkole (Ethical code: KIN/CHME/04/2020).
Results: The findings showed D-dimer levels higher than 500 µg/L in 87.7% of respondents, prolonged APTT (>40 seconds) in 43.1% of respondents, PT (<70%) in 36.9% of respondents, and thrombocytopenia (platelets <150,000) in 26.2% of respondents. A positive correlation was observed between socio-demographic characteristics and D-dimer levels.
Conclusion: SARS-CoV-2 infection has a significant impact on coagulation. Thus, determining these biomarkers could predict the risk of disease severity or death in patients with COVID-19.
Temidayo Adeniyi, Akinpelu Moronkeji, Victor Ekundina,
Volume 17, Issue 5 (9-2023)
Abstract
Background: Human activities continually impact the environment negatively. Some activities are particularly linked to river pollution, and this constitutes a major problem in certain regions of Nigeria. This is a result of economic development, anthropogenic human activities, and agricultural practice that have the potential for adverse health effects. This study evaluated the effect of heavy metals acquired from the waterways on the vital organs of experimental rats.
Methods: Seventy (70) adult male Wistar rats, average weighing between 150-180g, were divided into seven groups of ten animals, each selected by simple randomization. Pooled sampled water and water containing the highest average concentration of singly and combined heavy metals noted in the waterways from three geological zones in Kwara state, Nigeria, were respectively given to the Wistar rats within the treatment groups ad libitum for 65 days. The kidney, liver, and testes were harvested and processed for paraffin embedding, and the effect of the heavy metals was histologically assessed.
Results: Histological staining revealed variable histopathological alterations in the kidney, liver, and testes of rats in the treatment groups in comparison to the control group.
Conclusion: Increased levels of heavy metals in waterways can adversely affect the organs when used for household purposes. Activities in these water bodies must be checked by regulatory agencies, and laws to discriminate against the dumping of waste in water bodies should be enforced.
Shuchismita ., Iffat Jamal , Vijayanand Choudhary ,
Volume 18, Issue 1 (1-2024)
Abstract
Plasma cell leukemia (PCL) is a rare form of plasma cell dyscrasia with 2 variants: the primary form, which occurs de novo in patients with no previous history of multiple myeloma (MM), and the secondary form, which represents a leukemic transformation in patients with a previously recognized MM. Unlike myeloma, PCL typically follows an aggressive course, and the median age at presentation is usually above 50 years. In this report, we present a case of primary PCL that manifested at 19, an exceptionally rare occurrence.
Aliehsan Karshenas, Ramak Yahya Raiat, Taghi Zahraiee Salehi, Babak Asghari, Maryam Adabi,
Volume 18, Issue 2 (3-2024)
Abstract
Background: Escherichia coli consists of a wide range of strains with huge diversity in their genome, distributed in nature and the alimentary tracts of animals and humans. This study analyzed the phylogenetic group determination and genetic diversity of E. coli strains isolated from domestic animals and human clinical samples.
Methods: Twenty E. coli isolates from domestic animals were analyzed for phylogenetic grouping. Also, 100 clinical samples and 20 animal samples were evaluated by the enterobacterial repetitive intergenic consensus–polymerase chain reaction (ERIC-PCR) technique. The results and the similarity between the strains were determined based on the Dice similarity coefficient in the SAHN program of the NTSYS-pc software.
Results: The frequency of phylogroups among animal samples were A = 5%, B1 = 65%, B2 = 20%, and D = 10%. Based on the ERIC-PCR results, the clinical strains were allocated into 19 clusters. Most strains were in the E7 cluster. Fifty percent of the E. coli isolated from animal specimens belonged to the E4 group, and the lowest number of strains was in the E3 and E5 (1 strain) groups.
Conclusion: The results confirmed the efficiency and usefulness of the ERIC-PCR tool for the identification and classification of bacteria. Also, we demonstrated the most phylogroup among animal samples.
Toukam Michel, Voundi-Voundi Esther, Bole Bernard, Mviena Nyimbe Louise, Sahmo Simon Stevensen, Nogue Raissa, Kasia Jean Marie,
Volume 18, Issue 3 (5-2024)
Abstract
Background: Syphilis has serious consequences for human health and poses challenges for biological diagnosis. Techniques such as chemiluminescence are still poorly known in our context. Our objective was to compare chemiluminescence and hemagglutination assays with immunoblot as a reference test for detecting anti-Treponema pallidum antibodies.
Methods: Anti-Treponema pallidum antibodies were detected in serum samples. Comparison of chemiluminescence and hemagglutination assays was carried out with immunoblot as the reference test, based on sensitivity, specificity, positive and negative predictive values, and kappa statistic, using IBM-SPSS version 24 software. The significance level was set at 5%.
Results: A total of 600 participants were recruited, with a prevalence of syphilis infection of 3%. Sensitivity and specificity were 100% and 96.2% for chemiluminescence, and 93.8% and 100% for hemagglutination, respectively. Cohen's kappa statistic between the two tests showed satisfactory agreement (0.768). Cohen's kappa agreements between chemiluminescence/immunoblot and plate hemagglutination assay/immunoblot were greater than 0.8, indicating excellent agreement with the reference test (p<0.0001).
Conclusion: Chemiluminescence is more sensitive but less specific than hemagglutination. The use of chemiluminescence as a first-line test for the diagnosis of syphilis should be considered.
Aaa Abdelkarim Abdrabo, Israa Israa Elgaily,
Volume 18, Issue 4 (7-2024)
Abstract
Background: different analytes are available now in the area of laboratory medicine for evaluation of glycemic control, but many of them are with limitations, including glucose which reflects the glucose level at the time of blood collection plus, the sample is not stable and the glucose level affected by diet and stress., hemoglobin A1c (HbA1c), is the best for assessing long term control but high blood urea affects it.
Aim: to compare glycated albumin and HbA1c levels in assessing glycemic control among diabetic subjects on hemodialysis.
Methods: a cross-sectional comparative study was conducted on 280 volunteers, 115 were diabetic with end-stage of renal disease (ESRD), 95 were diabetic without ESRD, and 75 were non-diabetic patients with ESRD. HbA1c, glycated albumin, urea, and creatinine were measured using the available laboratory methods. The data were analyzed using a computerized SPSS program.
Results: levels of HbA1c were lower in diabetic patients with ESRD compared to diabetic without ESRD. In contrast, glycated albumin is higher in diabetics with ESRD. There is a significant negative association between levels of HbA1c with urea levels. Levels of creatinine are not associated with HbA1c and Glycated albumin.
Conclusion: it is better to use glycated albumin as a glycemic indicator among diabetic patients with ESRD.
Mohammadreza Sheikh Sajjadieh, Ali Ajamy,
Volume 18, Issue 4 (7-2024)
Abstract
Background and objective: Immunofluorescence and serology analysis are most common laboratory method in diagnosis of antinuclear antibody in autoimmune disease is significant for screening and therapeutic management. This study was designed to estimate sensitivity and specificity of antinuclear antibody which assayed by automated indirect immunofluorescence and enzyme-linked immune assay in patient who suspected autoimmune disease for selection a proper diagnostic method. Method: We analyzed serum antinuclear antibody in 3020 patient suspected autoimmune disease in Nobel Medical Laboratory, Esfahan, IRAN, since 2017 until 2020 with both automated indirect immunofluorescence and enzyme linked immune assay method. For each method was calculated sensitivity, specificity, prevalence, positive and negative predictive value and likelihood ratio. In addition Receiver operating characteristic curve (ROC) is analyzed to provide a statistical method for the assessment of the diagnostic accuracy of these tests. Result: The immunofluorescence method have obtained low sensitivity and high specificity compare with the enzyme-linked immune assay. For automated indirect immunofluorescence method, sensitivity and specificity was 88% and 62%, whereas the number for ELISA method determined 89.6% and 28.5 % respectively Conclusion: Choosing a suitable method for detection autoantibody based on the needy of diagnosis is essential. ANA analysis by high sensitivity test method like as enzyme linked immune assay should be used to screen population to capture the majority of cases and with high specificity like as indirect immunofluorescence assay should be used for confirmation result and monitoring of dynamic treatment.
