Dataset Information

Performance of Point-of-Care Testing Compared with the Standard Laboratory Diagnostic Test in the Measurement of HbA1c in Indonesian Diabetic and Nondiabetic Subjects.

ABSTRACT: Objective:This study is aimed at investigating if point-of-care testing for HbA1c (POCT-HbA1c) using the HemoCue® HbA1c 501 system could be an alternative method for diabetes screening and monitoring to replace the HbA1c measurement in a standard diagnostic laboratory. Design:This was a cross-sectional study to assess the agreement between POCT and a standard laboratory measurement method for determining the level of HbA1c. Setting and Participants. In total, 108 participants were recruited to participate in this study, consisting of 61 diabetics and 47 nondiabetics. The diabetic group comprised 37 females and 24 males, diagnosed with type 2 diabetes mellitus (DM) and undergoing diabetes treatment at several community health care centres in Bandung, West Java. The nondiabetic group consisted of 15 female and 32 male patients of several community health care centres and healthy volunteers. Sample Collection and Analysis. A venous blood sample was taken for routine HbA1c analysis by the diagnostic laboratory method. For the POCT-HbA1c, a blood sample was taken from the fingertip at the same time and analysed with the HemoCue® HbA1c 501 system. Outcome Measures. The HbA1c results of both methods were compared and analysed with a Bland-Altman agreement plot. The sensitivity and specificity of the POCT-HbA1c data were also compared with those of the standard diagnostic results. Results:Based on the Bland-Altman plot, the HbA1c level for 100 out of 108 (92.59%) subjects analysed by the POCT-HbA1c was within the range of the 95% limit of agreement. Compared with the standard diagnostic assay, the sensitivity of the POCT-HbA1c was 97.83% and its specificity was 77.42%. Conclusions:The high sensitivity and accuracy of POCT-HbA1c indicate that it is a potential method for diabetes screening and monitoring to replace the routine diagnostic laboratory HbA1c measurement, especially when a rapid result is required.

SUBMITTER: Berbudi A

PROVIDER: S-EPMC7369652 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Performance of Point-of-Care Testing Compared with the Standard Laboratory Diagnostic Test in the Measurement of HbA1c in Indonesian Diabetic and Nondiabetic Subjects.

Berbudi Afiat A Rahmadika Nofri N Tjahjadi Adi Imam AI Ruslami Rovina R

Journal of diabetes research 20200709

<h4>Objective</h4>This study is aimed at investigating if point-of-care testing for HbA1c (POCT-HbA1c) using the HemoCue® HbA1c 501 system could be an alternative method for diabetes screening and monitoring to replace the HbA1c measurement in a standard diagnostic laboratory.<h4>Design</h4>This was a cross-sectional study to assess the agreement between POCT and a standard laboratory measurement method for determining the level of HbA1c. <i>Setting and Participants</i>. In total, 108 participan ...[more]

PMID: 32733964

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Project description:The prevalence of diabetes in Singapore is high. Screening to facilitate early detection and intervention has been shown to be cost-effective. Current clinical practice guidelines in Singapore recommend screening with fasting plasma glucose (FPG), followed by an oral glucose tolerance test (OGTT) in those with FPG 6.1-6.9?mmol/L. Glycated haemoglobin A1c (HbA1c) has robust stability at ambient temperature, and can be performed on non-fasted capillary blood samples, making it an attractive potential alternative for screening. However, limitations of HbA1c include differential performance in different races, and its performance as a screening test has not been well characterized in Asian populations. This study compares HbA1c and FPG as diabetes screening modalities in 3540 community-dwelling Singapore residents of Chinese, Malay and Indian race to detect diabetes mellitus diagnosed based on blood glucose (FPG???7.0?mmol/L, 2?hr OGTT???11.1?mmol/L). The area under the receiver-operating-characteristic curve (AUC) was higher for FPG compared to HbA1c in the overall population and age, race and age-race strata, but these differences were not statistically significant. HbA1c >?=?7.0% identified 95% of individuals with diabetes mellitus, and the remainder had impaired glucose tolerance (IGT). HbA1c cut-off at 6.1% had better sensitivity (0.825) to FPG at 6.1?mmol/L. The positive predictive value of HbA1c at 6.1% was 40-50% in different age-race combinations with a negative predictive value of about 98%. If follow-up screening with FPG is used, a lower cut-off at 5.6?mmol/L is appropriate in identifying people with pre-diabetes, as about 85% of people with HbA1c 6.1-6.9% and FPG 5.6-6.9?mmol/L had IFG/IGT or diabetes in the study sample. HbA1c is an appropriate alternative to FPG as a first-step screening test, and the combination of Hba1c?>?=?6.1% and FPG?>?=?5.6?mmol/L would improve the identification of individuals with diabetes mellitus and prediabetes.

Project description:BackgroundNucleic acid-based amplification tests (NAAT), above all (q)PCR, have been applied for the detection of Mycobacterium leprae in leprosy cases and household contacts with subclinical infection. However, their application in the field poses a range of technical challenges. Loop-mediated isothermal amplification (LAMP), as a promising point-of-care NAAT does not require sophisticated laboratory equipment, is easy to perform, and is applicable for decentralized diagnosis at the primary health care level. Among a range of gene targets, the M. leprae specific repetitive element RLEP is regarded as highly sensitive and specific for diagnostic applications. METHODS: Our group developed and validated a dry-reagent-based (DRB) RLEP LAMP, provided product specifications for customization of a ready-to-use kit (intended for commercial production) and compared it against the in-house prototype. The assays were optimized for application on a Genie® III portable fluorometer. For technical validation, 40 "must not detect RLEP" samples derived from RLEP qPCR negative exposed and non-exposed individuals, as well as from patients with other conditions and a set of closely related mycobacterial cultures, were tested together with 25 "must detect RLEP" samples derived from qPCR confirmed leprosy patients. For clinical validation, 150 RLEP qPCR tested samples were analyzed, consisting of the following categories: high-positive samples of multibacillary (MB) leprosy patients (> 10.000 bacilli/extract), medium-positive samples of MB leprosy patients (1.001-10.000 bacilli/extract), low-positive samples of MB leprosy patients (1-1.000 bacilli/extract), endemic controls and healthy non-exposed controls; each n = 30. RESULTS: Technical validation: both LAMP formats had a limit of detection of 1.000 RLEP copies, i.e. 43-27 bacilli, a sensitivity of 92% (in-house protocol)/100% (ready-to-use protocol) and a specificity of 100%. Reagents were stable for at least 1 year at 22 °C. Clinical validation: Both formats showed a negativity rate of 100% and a positivity rate of 100% for high-positive samples and 93-100% for medium positive samples, together with a positive predictive value of 100% and semi-quantitative results. The positivity rate for low-positive samples was 77% (in-house protocol)/43% (ready-to-use protocol) and differed significantly between both formats. CONCLUSIONS: The ready-to-use RLEP DRB LAMP assay constitutes an ASSURED test ready for field-based evaluation trials aiming for routine diagnosis of leprosy at the primary health care level.

Project description:BackgroundMozambique is a high-prevalence country for HIV and early detection of new HIV infections is crucial for control of the epidemic. We aimed to evaluate the accuracy of the 4th-generation rapid diagnostic test (RDT) AlereTM HIV Combo in detecting acute and seroconverted HIV-infection, among sexually-active women attending three clinical health centers in Maputo, Mozambique.MethodsWomen aged 14-55 years (n = 920) seeking care at the Mavalane Health Area, Maputo (February 2018-January 2019) were included, and blood specimens sampled. Sociodemographic and sexual behavior data were collected. Point-of-care HIV testing was performed using Alere DetermineTM HIV-1/2 and Uni-GoldTM HIV-1/2. All samples were also tested using Enzygnost® HIV Integral 4 and Innotest® HIV Antigen mAb in laboratory. The 4th-generation RDT AlereTM HIV Combo was evaluated on serum samples in the laboratory. Finally, Innotest® HIV Antigen mAb, Enzygnost® HIV Integral 4 (Ag/Ab), and HIV RNA quantification acted as gold standard assays in the evaluation of AlereTM HIV Combo test for HIV antigen detection (in clinical samples and in three HIV-1 seroconversion panels).ResultsThe antibody component of the 4th generation AlereTM HIV Combo RDT demonstrated a sensitivity and specificity of 100% examining clinical samples. However, the test did not detect HIV p24 antigen in any clinical samples, while Innotest® HIV Antigen mAb, verified by Enzygnost® HIV Integral 4 (Ag/Ab) and/or HIV RNA quantification, detected HIV antigen in six clinical samples. Furthermore, the AlereTM HIV Combo RDT had a low sensitivity in the detection of HIV p24 antigen in seroconversion panels. The HIV prevalence among the examined women was 17.8%.ConclusionsThe 4th-generation RDT AlereTM HIV Combo showed similar sensitivity to the 3rd-generation RDTs to detect seroconverted HIV-infections. However, the sensitivity for detection of HIV p24 antigen and diagnosing acute HIV infections, before seroconversion, was low. There is an urgent need to develop and evaluate simple and affordable POC tests with high sensitivity and specificity for diagnosing individuals with acute HIV infection in resource-limited settings with high HIV prevalence.

Project description:BACKGROUND:Glycated haemoglobin (HbA1c) is an important outcome measure in diabetes clinical trials. For multicentre designs, HbA1c can be measured locally at participating centres or by sending blood samples to a central laboratory. This study analyses the agreement between local and central measurements, using 1-year follow-up data collected in a multicentre randomised controlled trial (RCT) of newly diagnosed children with type I diabetes. METHODS:HbA1c measurements were routinely analysed both locally and centrally at baseline and then at 3, 6, 9 and 12 months and the data reported in mmol/mol. Agreement was assessed by calculating the bias and 95 % limits of agreement, using the Bland-Altman analysis method. A predetermined benchmark for clinically acceptable margin of error between measurements was subjectively set as ±10 % for HbA1c. The percentage of pairs of measurements that were classified as clinically acceptable was calculated. Descriptive statistics were used to examine the agreement within centres. Treatment group was not considered. RESULTS:Five hundred and ninety pairs of measurement, representing 255 children and 15 trial centres across four follow-up time points, were compared. There was no significant bias: local measurements were an average of 0.16 mmol/mol (SD?=?4.5, 95 % CI -0.2 to 0.5) higher than central. The 95 % limits of agreement were -8.6 to 9.0 mmol/mol (local minus central). Eighty percent of local measurements were within ±10 % of corresponding central measurements. Some trial centres were more varied in the differences observed between local and central measurements: IQRs ranging from 3 to 9 mmol/mol; none indicated systematic bias. CONCLUSIONS:Variation in agreement between HbA1c measurements was greater than had been expected although no overall bias was detected and standard deviations were similar. Discrepancies were present across all participating centres. These findings have implications for the comparison of standards of clinical care between centres, the design of future multicentre RCTs and existing quality assurance processes for HbA1c measurements. We recommend that centralised HbA1c measurement is preferable in the multicentre clinical trial setting. TRIAL REGISTRATION:Eudract No. 2010-023792-25 , registered on 4 November 2010.

Dataset Information

Performance of Point-of-Care Testing Compared with the Standard Laboratory Diagnostic Test in the Measurement of HbA1c in Indonesian Diabetic and Nondiabetic Subjects.

Publications

Performance of Point-of-Care Testing Compared with the Standard Laboratory Diagnostic Test in the Measurement of HbA1c in Indonesian Diabetic and Nondiabetic Subjects.

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