Laboratory Services Research Articles

B-202 Clinical and analytical performance evaluation of Savanna RVP4 panel versus three methodologies

Abstract Background Rapid molecular diagnosis became a key solution for healthcare institutions across the world, after COVID-19 pandemic. It has enabled diagnosis based on improved quality, accuracy, analytical sensitivity, and turnaround times for laboratory services. It also has positioned this methodology as a trusted technology for point-of-care settings. These solutions also allow to consolidate combinations of different pathogen detection in panels. This study assessed the analytical and clinical performance of the novel Savanna RVP4 panel against other available methodologies. Methods A prospective study was performed, considering 84 patient samples obtained from nasopharyngeal swabs. Samples were processed in parallel after collection, using Savanna RVP4, and either QIAstat-Dx Respiratory SARS-CoV Panel (59 samples), Sansure iPonatic (10 samples) and BioFire® Respiratory 2.1 (RP2.1) Panel (15 samples). Samples were collected in either MTU, commercial or homemade PBS. Results Overall clinical sensitivity and specificity were 96.43% and 99.64%, respectively for the aggregated panels (Table 1). By technology, the overall clinical sensitivity and specificity were 93.75% and 99.51% versus QIAstat, 100% and 100% versus Biofire, respectively. For iPonatic comparisons, no positive samples were processed and 100% of specificity was obtained. Cycle threshold (Ct) values for positive samples were compared using box plots. Ct values also showed slighlty differences, where means were lower for RSV and Flu A in Savanna (22 and 22.9 respectively) versus other PCR assays (22.5 and 24.5 respectively). For SARS-CoV-2, Ct values were higher versus other methods (19.8 vs 13.6). Conclusions Results obtained with Savanna RVP4 were comparable to those obtained with other methodologies, correlating with patient clinical symptoms. Samples showing disagreement for QIAstat comparison panel, in Flu A and RSV assays, corresponded to the same patient samples for the two methodologies, where Ct obtained in QIAstat were above 33. This evaluation also provides strong evidence supporting PBS usage for samples processed in Savanna RVP.

Reducing colorectal cancer mortality in South Africa: experiences and progress from the South African National Cancer Prevention Services

Aim The incidence rates of colorectal cancer are rapidly increasing in South Africa. Previous studies have shown that the prevalence of inherited colorectal cancer in South Africa is 3-5 times higher than in high-income countries. Targeted screening and surveillance programmes for individuals with known colorectal cancer-causing mutations have resulted in increased life expectancy. The South African National Cancer Prevention Services (SANCaPS), was established to implement national systems for identifying individuals with inherited cancers, improving their clinical management, and reducing the overall disease burden. Methods Using colorectal cancer as an example, SANCaPS aimed to extend surveillance and management practices from the Western Cape to a national level. The goals included improving the quality of pathology reporting, establishing counselling systems for at-risk individuals, developing cost-effective mutation detection protocols, identifying and counselling at-risk family members, providing mutation testing, organising endoscopic surveillance programmes for high-risk individuals, setting ethical frameworks for research, and extrapolating learnings from the inherited colorectal cancers surveillance programme to other cancers with known hereditary predispositions. Results SANCaPS initiated the standardisation of national pathology reporting for colorectal cancers. Currently, a minimum core pathology dataset collection is being piloted in the National Health Laboratory Service’s TrakCare system. Subsequently, SANCaPS aims for broader adoption through stakeholder engagements. This will help to identify patients with mismatch repair-deficient colorectal cancers, facilitate research, and improve reporting. Conclusions To improve patient outcomes, this consultative process and framework will be replicated to introduce standardised management workflows for other common cancers, including breast, prostate, uterine, and others.

Workflow improvement and financial gain after integration of high-throughput sample processing system with flow cytometer in a high-volume pathology laboratory: Results from a prospective comparative study using Lean principles

BackgroundHighly efficient clinical laboratories are essential for monitoring many human illnesses. Ampath Laboratory Services, the largest pathology lab in South Africa, analyzes large numbers of peripheral blood samples for CD4 levels yearly. ObjectiveTo assess productivity and quality of a newer integrated automated solution, the BD FACSDuet™ Sample Preparation System/BD FACSLyric™ Flow Cytometer using conventional assessment methods and Lean concepts. Materials and methodsThis prospective study compared the performance of the BD FACS™ Sample Preparation Assistant [SPA] III and BD FACSCanto™ II Flow Cytometer with the newly introduced integrated system (BD FACSDuet™/BD FACSLyric™). They were validated for accuracy, precision, and external quality assessment. Process mapping and Lean assessment helped identify steps leading to waste. An economic model was developed to characterize workflow and economic impact associated with total daily hands-on time, processing time, and reworks. ResultsStrong linear correlation was present between both systems. Precision and accuracy studies revealed that all coefficient of variation (CV)% values were below 20 % of allowable limits. External proficiency assessments were within limits. The fully automated workflow of BD FACSDuet™/BD FACSLyric™ permitted better consistency with significantly shorter processing time and batch processing and reduced operator interventions. Lean assessment identified defects with motion, over-processing, waiting, and non-utilized talent. Significant reductions in hands-on and total daily processing time that could increase daily specimen testing efficiency and fewer reworks were associated with the BD FACSDuet™/BD FACSLyric™. Lean improvements translated to significant economic savings associated with operator costs and unnecessary reagent consumption. ConclusionBD FACSDuet™/BD FACSLyric™ is an accurate, reliable, and cost-effective fully automated system for high-volume flow cytometry labs that perform T-cell enumeration using a single-platform and single-tube approach.

The implementation and outcome of a breast cancer genetic counselling service at Potchefstroom Hospital: a model for outreach

Aim Breast cancer is the most prevalent cancer in South African females, making up 27.1% of all histologically diagnosed cancers in 2020. Although genetic technology and awareness of genetic counselling have improved, genetic counselling services in South Africa remain largely inaccessible. Clinical genetic services are only formally available in four South African provinces and few outreach programmes exist for small towns and cities. Until 2019, genetic counselling services were unavailable in the North West province; however, since then, genetic counsellors from the National Health Laboratory Service and the University of the Witwatersrand have provided genetic counselling services to patients at the Breast Clinic at Potchefstroom Hospital regularly each year. Method The aim of this pilot study was to perform a retrospective file review and report on the implementation and outcomes of the genetic counselling service at the Breast Clinic at Potchefstroom Hospital, from its inception in 2019, until November 2022. Fifty-two patients attended a genetic counselling consultation during that period. Results The majority of patients (83.7%) were diagnosed with an invasive ductal carcinoma, and 57.7% of the patients had a family history of cancer. A total of 62.8% of patients had a histologic grade 3 tumour. A total of 25.5% (12/47) of patients tested positive for a pathogenic variant in BRCA1 or BRCA2. A total of 45 at-risk first-degree relatives were identified who could benefit from predictive testing. Conclusions This study highlights the benefit of offering clinical genetics services through outreach clinics. Being able to offer this service is not only beneficial for the management of the affected individuals, but also for their at-risk relatives. The initiative serves as a positive example of how limited resources can be extended to benefit patients.

A Bibliometric Analysis of the Errors and Mistakes in the Medical Laboratory

Abstract Background: The increasing number/varieties of tests and rising demands are reasons for the increasing challenges to laboratory professionals, such as increasing workloads, maintaining turnaround time, and quality improvement. Furthermore, the laboratory faces many occupational hazards due to negligence or lack of knowledge regarding biosafety guidelines among the laboratory professionals. A laboratory involves mechanical, chemical, biological, and environmental components of activities, and errors/mistakes/ignorance in any of these disciplines create hazards and risks to people working inside the laboratory. Objective: We aimed to identify the types of errors, accidents, and ignorance in medical/clinical laboratories that have been published or presented worldwide. Materials and Methods: We performed a bibliometric analysis to search and analyze those studies which are published in different journals as articles or reviews, or published as books or chapters, and even, those presented as conference papers and short surveys. Results: The bibliometric analysis shows the pre-analytical phase as the most vulnerable to errors due to human errors and other activities outside the laboratory, which are beyond the control and preview of laboratories many times. A few studies suggest an increase in several tests and a lack of awareness among physicians while ordering the test as one of the reasons for the poor efficiency of laboratory services. Similarly, ignorance of the safety measures leads to occupational hazards among laboratory professionals. Conclusion: The study recommends focusing on the pre-analytical phase and providing awareness to clinicians about the tests conducted by the respective laboratories. This study also highlights that errors in the laboratory should be published for future records and learning.

Are social protection and food security accelerators for adolescents to achieve the Global AIDS targets?

Without effective, scalable interventions, we will fail to achieve the Global AIDS Targets of zero AIDS-related deaths, zero HIV transmission and zero discrimination. This study examines associations of social protection and food security among adolescents living with HIV (ALHIV), with three Global AIDS Targets aligned outcomes: antiretroviral treatment (ART) adherence and viral suppression, HIV transmission risk behaviour and enacted stigma. We conducted three study visits over 2014-2018 with 1046 ALHIV in South Africa's Eastern Cape province. Standardized surveys provided information on receipt of government-provided cash transfers and past-week food security, alongside self-reported ART adherence, sexual debut and condom use, and enacted HIV-related stigma. Viral load (VL) data was obtained through data extraction from patient files and linkage with National Health Laboratory Service test results (2014-2020). We used a multivariable random-effects regression model to estimate associations between receiving government cash transfers and food security and three outcomes: ART adherence and viral suppression, delayed sexual debut or consistent condom use and no enacted stigma. We tested moderation by sex and age and fitted disaggregated models for each outcome. Among the 933 ALHIV completing all three study visits, 55% were female, and the mean age was 13.6 years at baseline. Household receipt of a government cash transfer was associated with improvements on all outcomes: ART adherence and viral suppression (aOR 2.03, 95% CI 1.29-3.19), delayed sexual debut or consistent condom use (aOR 1.62, 95% CI 1.16-2.27) and no enacted stigma(aOR 2.33, 95% CI 1.39-3.89). Food security was associated with improvements on all outcomes: ART adherence and viral suppression (aOR 1.73, 95% CI 1.30-2.30), delayed sexual debut or consistent condom use (aOR 1.30, 95% CI 1.03-1.64) and no enacted stigma (aOR 1.91, 95% CI 1.32-2.76). Receiving both cash transfers and food security increased the probability of ART adherence and VL suppression from 36% to 60%; delayed sexual debut or consistent condom use from 67% to 81%; and no enacted stigma from 84% to 96%. Government-provided cash transfers and food security, individually and in combination, are associated with improved outcomes for ALHIV aligned with Global AIDS Targets. They may be important, and underutilized, accelerators for achieving these targets.

Demographic and pathogen characteristics of incident bacterial meningitis in infants in South Africa: A cohort study.

Bacterial meningitis is a major cause of death, with an approximate case fatality rate of 37% across all age groups in South Africa. This study aimed to describe the demographic and pathogen characteristics of incident meningitis in children aged <1 year in South Africa from 2014 through 2018, during a period when Haemophilus influenzae type b vaccine and pneumococcal conjugate vaccines (PCV) were both included in the expanded program on immunization (EPI). We conducted a cohort study of routine laboratory data in the National Health Laboratory Service Corporate Data Warehouse, which covers approximately 80% of the South African population. We defined a case of laboratory-confirmed bacterial meningitis as any person aged <1 year with meningitis diagnosed by culture and identification of a pathogen documented as being a common cause of meningitis in CSF. The cause-specific incidence risks were calculated by dividing the number of positive specimens in each age group and year by the corresponding mid-year population for children under 1 year old and those in the post-neonatal period (≥ 28 days to 365 days old). For children under 28 days old, the annual numbers of registered livebirths were used. We used Poisson regression to compare the incidence of meningitis by year. We identified 3575 (1.5%) cases of culture-confirmed bacterial meningitis from the 232,016 cerebrospinal fluid (CSF) specimens tested from 2014-2018. The highest number of cases were recorded in children aged <28 days (1873, 52.4%), male children (1800, 50.4%) as well as in the Gauteng Province (2014, 56.3%). Acinetobacter baumannii (14.9%), followed by Klebsiella pneumoniae (13.5%), and group B streptococcus (GBS) (10.7%), were the most common pathogens detected. Overall, A. baumannii had the highest incidence risk, occurring at 9.8 per 100,000 persons in children aged <1 year in 2018. Among neonates, A. baumannii peaked at 14.9 per 100,000 livebirths in 2018, while Streptococcus pneumoniae was most common in the post-neonatal period (≥ 28 days to 365 days old), peaking at 9.8 per 100,000 persons in 2014. There was an increase in the annual incidence of most pathogens over the study period. There was an increasing trend in the annual incidence of bacterial meningitis in infants caused by most pathogens, particularly A. baumannii, K. pneumoniae and GBS. In addition to increased uptake of vaccination, prevention measures to reduce nosocomial and mother-to-child transmission of bacteria could include antenatal screening for GBS in pregnant women, rigorous hygiene in the hospital environment as well as rational antibiotic use.

Cohort profile: Rahima Moosa Mother and Child Hospital maternal HIV cohort, Johannesburg, South Africa

PurposeThe Rahima Moosa Mother and Child Hospital (RMMCH) maternal HIV cohort originated from data systems that were developed to support HIV-related birth care and track outcomes of a complete birth...

Performance of an in-house multiplex PCR assay for HIV-1 drug resistance testing – A cheaper alternative

BackgroundCurrently, most HIV drug resistance PCR assays amplify the protease-reverse transcriptase (PR-RT) fragment separately from the integrase (IN) fragment. The aim of this study was to develop a multiplex PCR assay that simultaneously amplifies PR-RT and IN fragments for HIV-1 drug-resistance testing. MethodsThe in-house multiplex PCR assay was evaluated on extracted total nucleic acids obtained from the National Health Laboratory Service (NHLS) and Lancet laboratories. Sanger sequencing was performed on amplicons, and HIV-1 drug-resistance mutations (DRMs) were assessed using HIV Stanford drug resistance database. ResultsThis study tested 59 patient samples with known HIV-1 viral load and DRM results; 41 from Lancet and 18 from NHLS. In-house multiplex PCR assay detected one or both fragments in most samples but had higher sensitivity for detection of IN fragment (93.2 %) compared to PR-RT fragment (83.1 %). There was 100 % concordance between Lancet assay versus in-house assay sequence data for IN DRMs, but lower concordance with PR-RT (87.0 %). The in-house multiplex PCR assay’s precision and reproducibility analysis showed ≥99.9 % sequence similarity and yielded similar DRM results for both PR-RT and IN fragments. ConclusionsThe in-house multiplex PCR assay demonstrated satisfactory performance and higher sensitivity for IN fragment amplification. This could be a cost-effective method for HIV-1 drug resistance testing as both PR-RT and IN fragments are successfully amplified in one reaction in most samples.

Effects of temperature and storage duration on quality of an insect artificial diet.

Artificial diets are widely used to produce insects for research and education programs. Completed diets, in which the diets are fully made from individual ingredients and ready to use, often have high water activity, making them vulnerable to degradation. Proper storage is critical to maintaining diet quality, yet the storage conditions are not well investigated. In this study, we characterized the effects of storage conditions (temperatures and storage duration) on the quality of a diet capable of rearing both specialist and generalist insect species. The completed diet, produced by both private industry and a USDA-Agricultural Research Service laboratory, was exposed to varying temperatures during a 24-hour transit over 1600km. After transit, it was stored at 4°C for a total storage period of 28 days. In a separate experiment, the completed diet was stored immediately after diet production at five fixed temperatures (-20, 4, 22, 25, and 33°C) for up to 28 days. For both experiments, at 5 intervals after storage (1, 7, 14, 21, and 28 days), diet quality was accessed by life history parameters (survival, molting, and weight) of western corn rootworm (Diabrotica virgifera virgifera LeConte) larvae, the most serious maize pest in the United States. Our results showed that exposure to varying temperatures between -2°C and 27°C for 24 hours had no significant impact on diet quality. However, extended storage (beyond 24 hours) at any of the fixed temperatures negatively affected diet quality. Insects reared on diets stored for over 24 hours at fixed temperatures ranging from -20°C to 33°C had significant declines in performance. Among the tested temperatures, -20°C and 4°C were found to be the most effective for preserving diet quality. At these low temperatures, there were no significant changes in insect weight and survival for diets stored within 21 and 28 days, respectively, though molting was significantly reduced within 7 days of storage. These findings provide the base of information on the storage conditions for completed diets, supporting the production of healthy insects.

Profile of Laboratories With the Seal of the Clinical Laboratory Accreditation Program (PALC)

Objective: The objective of this study is to analyze clinical analysis laboratories accredited by the quality seal of the Clinical Laboratory Accreditation Program (PALC) in Brazil. Theoretical Framework: It presents the fundamentals of the research, covering the importance of hospital accreditation, PALC regulations, historical evolution of hospital quality, economic impact on health, quality management in clinical laboratories and the usefulness of quality indicators. Method: A documentary study was carried out, with descriptive and quantitative analysis. During the study period, 163 clinical laboratories were detected in the country accredited by the PALC seal. Results and Discussion: In the study, 163 accredited clinical laboratories were identified in Brazil, with only 32 laboratories in the entire northeast region. Where 92% of accredited laboratories are private and 82% are part of large national diagnostic networks. Highlighting the need for greater investment in quality seals, which better certify the quality of the laboratory service provided. Research Implications: The importance of policies and strategies to promote the accreditation of clinical laboratories stands out, especially in the northeast region of Brazil, aiming to improve the quality and reliability of health services provided to the population, in addition to promoting greater security in medical diagnoses. Originality/Value: This study contributes to the literature by highlighting the originality by examining the grographic distribution and the public and private nature of accredited clinical laboratories in Brazil. The relevance and value of this research are evidenced by its crucial role of accreditation in ensuring quality laboratory services, encouraging continuous improvement and patient confidence.

PSLBI-30 SARS-CoV-2 Screening and Detection: Assessment of surrogate virus neutralization test (svNT) diagnostic appropriateness in multispecies SARS-CoV-2 virus screening and detection

Abstract The National Veterinary Services Laboratories (NVSL) have been testing animal samples since the 2020 SARS-CoV-2 outbreak. The current “gold standard” for serodetection of SARS-CoV-2 is the virus neutralization (VN) test. This method requires specialized training, more time to complete, and specialized facilities (BSL 3). Therefore, the SARS-CoV-2 VN test is not widely run outside of NVSL. To facilitate increased testing capacity during the outbreak, the surrogate virus neutralization test (sVNT) was selected mid-2020. This commercially available kit uses an ELISA format, giving a percent inhibition (%I) cut-off value to indicate “negative” or “positive,” allowing for faster testing turnaround. Despite its widespread use in many species, an in-depth, multispecies analysis of the data comparing sVNT to VN results has not been reported. Such an analysis is useful to assess the diagnostic appropriateness of the sVNT test for SARS-CoV-2 virus screening and detection across multiple species. Results were considered from all serological samples submitted to NVSL from March 2020 to May 2023 for routine SARS-CoV-2 diagnostic testing. Of these, samples with results for both VN and sVNT testing were considered for further analysis (n = 942). Samples were sorted by the species and family levels, and were assessed for rates of “true positive,” “false positive,” “true negative,” and “false negative” by sVNT, using paired VN results as the indicator of the true status of the sample. Additionally, the increased sVNT cut-off threshold for %I (20%I to 30%I for “positive”) was assessed for appropriateness by species using mean %I values for VN-positive samples. Increasing sVNT %I cut-off threshold for “positive” results from 20%I to 30%I resulted in 58 samples being correctly re-classified as “negative” by sVNT, rather than “positive” at the 20%I cut-off threshold. The mean %I values for most species fell between 40 to 80%I, except for Felidae, which had a mean %I of 93%I, and a minimum %I of 40.6%I for VN-positive samples. The true negative (sVNT/VN-NEG) rates for most species fell between 97to 100%, with 0 to 3% being false negatives (svNT-NEG, VN-POS), with very few exceptions. However, the least false positive (sVNT-POS;VN-NEG) rate was 8.8%, ranging up to 100% false positives for Equidae and one species of Cervidae. While the mean %I for most species indicates the cut-off value is appropriate (for those species where sVNT is an appropriate diagnostic), overall, the results highlight a lack of precision and specificity of the sVNT for many animal species. This indicates a lack of diagnostic appropriateness of the sVNT as a SARS-CoV-2 screening tool for certain species and a need for refinement in cut-off values for other species. The sVNT as a screening tool varies considerably by species for serodetection of SARS-CoV-2, results should be interpreted with caution, and use of other confirmatory tests is recommended.

Update on Patient Self-Testing with Portable and Wearable Devices: Advantages and Limitations.

Laboratory medicine has undergone a deep and multifaceted revolution in the course of human history, in both organizational and technical terms. Over the past century, there has been a growing recognition of the need to centralize numerous diagnostic activities, often similar or identical but located in different clinical departments, into a common environment (i.e., the medical laboratory service), followed by a progressive centralization of tests from smaller laboratories into larger diagnostic facilities. Nevertheless, the numerous technological advances that emerged at the beginning of the new millennium have helped to create a new testing culture characterized by a countervailing trend of decentralization of some tests closer to patients and caregivers. The forces that have driven this (centripetal) counter-revolution essentially include a few key concepts, namely "home testing", "portable or even wearable devices" and "remote patient monitoring". By their very nature, laboratory medical services and remote patient testing/monitoring are not contradictory, but may well coexist, with the choice of one or the other depending on the demographic and clinical characteristics of the patient, the type of analytical procedure and the logistics and local organization of the care system. Therefore, this article aims to provide a general overview of patient self-testing, with a particular focus on portable and wearable (including implantable) devices.

Tuberculosis patients’ satisfaction with directly observed treatment short course strategy and associated factors in Southern Ethiopia: a mixed method study

AabstractBackgroundTuberculosis (TB) is a second major global public health problem and the leading infectious cause of death in Ethiopia. Patients under directly observed treatment short-courses (DOTs) have a higher treatment success rate and reduced drug resistance. A successful treatment outcome and adherence to the treatment are related to patient satisfaction with the DOT strategy. Client satisfaction is one of the indicators of the quality of care. In this perspective, there were limited studies in Ethiopia related to patient satisfaction with the DOTs strategy in the prevention and control of TB to achieve the ‘’END TB Strategy.’’ Therefore, this study was aimed at identifying the TB patients’ satisfaction with the DOTs strategy and associated factors in Gamo Zone, Southern Ethiopia.MethodsAn institutional-based cross-sectional study design for quantitative data and a phenomenological approach were employed for qualitative data. The calculated sample size was 374. A systematic random sampling method was used to select study participants. A pre-tested structured interviewer-administered questionnaire for quantitative data and focus group discussions (FGDs) for qualitative data were used for data collection. Bivariable and multivariable analyses were used. The determinants with a p-value < 0.05 were declared to have a significant association with the outcome variable, and an adjusted odd ratio with a 95% confidence interval (CI) was used.ResultsA total of 358 patients participated in the study, with a response rate of 95.72%. The majority of study participants’ ages ranged between 25 and 34 years. The tuberculosis DOT satisfaction rate was 61.17% [56.10-66.25%, 95%CI]. The TB patients who took treatment for 20 weeks or more were 3.97 times [AOR = 3.97; 95% CI (1.55–10.16)] more likely to be satisfied with the DOTs service provided. However, the participants who perceived transport costs as high were 79% [AOR = 0.21; 95% CI (0.06–0.71)] less likely to be satisfied with DOTs. Qualitatively, the participants reported that there was a major problem with laboratory services, which resulted in delays and long appointments to get the results in addition to lack of clean toilets and safe water to swallow medications.ConclusionThe satisfaction rate for tuberculosis DOTs observed in this study appears to be relatively lower in comparison to other studies. Availing DOTs service nearby patients to enhance the accessibility of the service is crucial to improving patients’ satisfaction with DOTs service. Reducing laboratory result delays by improving laboratory service is essential to enhancing patients’ satisfaction with DOTs. Moreover, improving toilet services, and availing safe water to swallow medications is recommended to enhancing patients’ satisfaction with DOTs service.

Assessing compliance with national guidelines in diabetes care: A study leveraging data from south Africa's National Health Laboratory Service (NHLS).

Diabetes is a major global health issue. We evaluated compliance to laboratory-based management guidelines for diabetes (type 1 and 2), essential for effective treatment and reducing diabetes-related morbidity and mortality. Our study utilized South Africa's National Health Laboratory Services (NHLS) data, focusing on patients from birth to age 80 years who underwent initial diabetes laboratory testing between January 1, 2012-January 1, 2016. Patients were categorized into type 1 (<30 years) or type 2 (≥30-80 years) diabetes based on age at first diabetes test. National diabetes guidelines recommend blood glucose to be checked every three-six months post laboratory-diagnosis. We employed a sharp regression discontinuity design to estimate the effect of a laboratory-diagnosis of diabetes on the likelihood of having a follow-up laboratory test 24 months post-diagnosis. Among patients with type 2 diabetes, the probability of a diabetes follow-up laboratory test within 24 months was 52.4% for patients presenting above the diabetes diagnosis threshold vs 31.1% for those presenting below. Although the likelihood of repeat testing rose with higher HbA1c and glucose levels, at the diagnostic threshold there was no clinically meaningful difference (risk difference: -2.2%, 95% CI: -3.3%, -1.2%). These results were consistent among patients with type 1 diabetes, those living with and without HIV, and healthcare setting. In a national laboratory cohort, diabetes laboratory-diagnosis did not lead to increased monitoring as recommended in national guidelines. Strategies to improve patient education, healthcare provider communication, and healthcare system support are essential to enhance guideline compliance and overall diabetes management.

Penerapan Aplikasi Manajemen Laboratorium Dinas Lingkungan Hidup Kota Palembang

Waste samples that is managed properly will generate added value and provide benefits for environmental management. The purpose of this study is to design a web-based waste water sample data management information system so that it can make it easier for waste laboratory staff and the public as customers and admins to manage and access waste water sample data and transactions. The method used in data collection is the DevOps method and it is also not important as a researcher to interview officials from the Palembang city environmental service regarding the laboratory management application program.. In making the website, the author uses the PHP and MySQL programming languages with the DevOps development method, object-based software modeling using UML and designing the system interface to show system functions. Database design is made to show the relationship between entities and data contained in the system. Users who will use the waste laboratory management application information system are employees of the environmental service laboratory unit as admin and the public. The results of this study indicate that the website design that was built can make it easier for the admin to manage waste water sample data, it can be stored in a database and can be accessed at any time. Apart from that, for residents,, this system has the benefit of accelerating the process of collecting waste in their environment, this system has the benefit of speeding up the process of collecting waste water sample data.

Long-term effect of pneumococcal conjugate vaccines on invasive pneumococcal disease incidence among people of all ages from national, active, laboratory-based surveillance in South Africa, 2005–19: a cohort observational study

In South Africa, 7-valent pneumococcal conjugate vaccine (PCV7) was introduced in 2009 and 13-valent PCV (PCV13) was introduced in 2011, both in a two plus one schedule. We evaluated the ongoing effects of PCV on the prevention of invasive pneumococcal disease (IPD) over 15 years of sustained surveillance in South Africa before the COVID-19 pandemic. We conducted national, active, laboratory-based surveillance for IPD among all ages in South Africa, including isolate serotyping and susceptibility testing. We fitted linear regression models with vaccine covariates to imputed IPD case counts each year by serotype and age to compare expected and actual IPD cases in 2019, which was the main outcome. Vaccine effects were set to zero to identify expected incidence after the introduction of PCV7 and PCV13. From Jan 1, 2005, to Dec 31, 2019, surveillance identified 52 957 IPD cases. Among the 50 705 individuals with age data available, 9398 (18·5%) were infants aged younger than 2 years. Compared with expected case numbers (no vaccination) predicted using all available data, overall IPD rates among children younger than 2 years declined by 76·0% (percentage risk difference; 95% CI -79·0 to -72·8%) in 2019; notably, PCV7 and additional PCV13 serotype IPD rates declined by 95·5% (-97·0 to -93·4%) and 93·8% (-96·2 to-90·5%), respectively, whereas non-vaccine serotypes (NVTs) did not change significantly. Among adults aged 25-44 years, overall IPD declined by 50·4% (-54·2 to -46·3%), and PCV7 and additional PCV13 serotype IPD rates declined by 86·1% (-88·7 to -83·1%) and 77·2% (-80·9 to -73·0%), respectively, whereas NVTs increased by 78·5% (56·8 to 103·4%). Individuals aged older than 64 years also benefited from declines in IPD (-30·2%; -41·9 to -16·2%), but NVTs increased (234·9%; 138·1 to 379·4%). We documented sustained direct and indirect benefits of PCV across age groups, and NVT increases in adults older than 24 years. Higher valency PCVs would have the added benefit of preventing this residual disease. National Institute for Communicable Diseases of the National Health Laboratory Service (South Africa) and US Agency for International Development Antimicrobial Resistance Initiative, US Centers for Disease Control and Prevention.

Prevalence of Thyroid Dysfunction among Patients with Chronic Kidney Disease Attending Diagnostic Laboratory Services, Bulawayo, Zimbabwe

Prevalence of Thyroid Dysfunction among Patients with Chronic Kidney Disease Attending Diagnostic Laboratory Services, Bulawayo, Zimbabwe

A review on quality management system in laboratory testing

A Laboratory Quality Management System (LQMS) refers to a set of policies, procedures, and practices implemented in a laboratory to ensure consistent quality and accuracy in its operations. Continuous improvement of laboratory quality service is vital to ensure accuracy, reliability, and timeliness of laboratory results. Implementation of the quality management system is an effective way of monitoring and assuring laboratory quality service. Various standards and regulations outline specific requirements for implementing a Quality Management System (QMS) in a laboratory environment, such as ISO 15189:2022, ISO 17025:2017, and FDA 42 CFR Part 493. These standards provide guidelines and criteria for laboratory processes, including testing, calibration, documentation, personnel competency, and overall quality control. This article will discuss the applicable standards and legislation, the 12 essential elements of laboratory QMS, and the role of QMS software in a laboratory environment. The objective of this study is to assess the impact of laboratory quality management system implementation on improving quality laboratory service.

Health disparities among incarcerated populations: a crucial laboratory and pathology review.

The United States notoriously has one of the highest rates of incarceration in the world, yet scant attention to the health care needs of those incarcerated exists within laboratory medicine and pathology training and education. This article explores health disparities among incarcerated and released individuals regarding diagnostic laboratory testing and pathology services. A literature search was conducted for articles published between 2002 and 2023 using keywords including "healthcare," "incarcerated," "laboratory services," "pathology services," and "health insurance for prisoners." Central themes were extracted and discussed to reveal the realities of health care during and after release from incarceration. Excluded from the analysis were articles about the immediate or extended family of incarcerated persons. Incarcerated individuals have an increased risk for the development and exacerbation of communicable and noncommunicable diseases and mental health disorders, which results in exceedingly high morbidity and mortality rates. Policy changes are needed to mitigate disparities and improve health outcomes for incarcerated and released persons. Central to these disparities is decreased access to laboratory and pathology services, impeded by inadequate health care funding for these carceral institutions. Providing additional funding to the carceral system's health care budget is necessary to improve access to pathology and laboratory services.