High-volume Testing Research Articles

B-232 One Year Post-Implementation Experience Using a Custom Designed DNA Contamination Detection Module for a Clinical Myeloid Neoplasm Next Generation Sequencing Assay

Abstract Background In complex automated clinical laboratory Next Generation Sequencing (NGS) workflows, numerous opportunities exist for contamination events to occur. For oncology testing applications, detection of these events is crucial for accurate results reporting. A contamination detection module (MICon) using microhaplotype (MH) regions and an in-house designed analysis model was developed for use in a NGS assay for myeloid neoplasms (NGSHM) [1]. Variant detection for NGSHM has a validated analytical sensitivity of 2% variant allele frequency (VAF). Gross contamination events can potentially cause erroneous false positive variant detection whereas true low VAF mutations may be masked and evade detection. The following study was performed to evaluate MICon module performance on samples processed over the course of a year. Methods MH regions contain highly conserved tandem single nucleotide polymorphisms (SNPs) with high global heterogeneity occurring within a 300-nucleotide span. From the work of Kidd et al [2], 27 MH regions covering 92 SNPs and spanning 16 chromosomes were selected for inclusion in the 47 gene NGSHM target-capture panel. Sequencing was performed on a NovaSeq 6000 and analyzed through an internal bioinformatics pipeline, which incorporates the MICon module. MICon uses a binary classification model incorporating VAFs from MH regions, number of MH genotypes, and the contamination estimation score from verifyBamID to compute a single value on a 0-100 scale. Scores <50 are classified as non-contaminated and scores ≥50 require further investigation. Results The dataset was comprised of 10,990 samples. A total of 10,232 patient cases (93.1%) had non-contaminated MICon scores <50. Control replicates accounted for 261 samples (2.4%). There were 497 patient cases (4.5%) with MICon scores ≥50. Of the 497 patient cases, 137 (27.6%) had undergone hematopoietic stem cell transplantation (HSCT) and 114 (22.9%) contained gross chromosomal abnormalities, representing iatrogenic or tumor biological factors. An additional 135 (27.2%) of cases were contaminated from laboratory processing errors, 45 (9.1%) occurred due to chemistry failures during run processing, and 66 (13.2%) had an undetermined cause for a high score, representing laboratory-related and unknown factors. Overall, the 135 laboratory processing errors detected accounted for 1.3% of patient cases analyzed by the laboratory. These cases were repeated, and the non-contaminated results were accurately reported. Conclusions Herein it was shown the implementation of MICon has improved patient safety over the course of a year. The 1.3% of patient cases identified as arising from laboratory processing errors were successfully reprocessed. While the overall rate of laboratory processing errors appears low, the absolute number can be significant in a high-volume test setting, despite reliance on highly automated processes. Value is added by MICon through identifying errors that could result in the release of inaccurate patient results. By detecting previously unrealized errors, MICon has become an invaluable asset to the NGSHM assay by enhancing patient laboratory testing safety.

Ứng dụng của test chọc tháo dịch não tủy trong chẩn đoán và điều trị giãn não thất áp lực bình thường nguyên phát: ca lâm sàng

Normal Pressure Hydrocephalus (NPH) is a clinical syndrome characterized by gait disturbance, cognitive decline, and urinary incontinence accompanied by ventricular enlargement without increased intracranial pressure. NPH is a diagnosis of particular note as it differs from other neurodegenerative disorders such as Alzheimer’s and Lewy body disease. Symptoms may improve if diagnosed and treated promptly. Clinical symptoms of the disease were first described by Salomon Hakim and R.D. Adam in 1965, though they are common but not specific enough. Additionally, age-related ventricular enlargement and periventricular white matter damage are found in various conditions, both in normal individuals and in other cognitive decline disorders (vascular cognitive impairment, Alzheimer’s), making early diagnosis challenging. Treatment of NPH mainly relies on surgical intervention with ventriculoperitoneal shunting, with accurate preoperative diagnosis being crucial for success.Lumbar puncture (LP) can be considered the most important procedure to demonstrate the underlying pathophysiology of NPH, which is normal pressure hydrocephalus. High-volume lumbar tap test (LTT) is a relatively simple and effective method when clinical-radiological suspicion is present: it helps to distinguish NPH from other conditions with ventricular enlargement and aids in predicting the success of ventriculoperitoneal shunting surgery. The clinical case presented below illustrates the value of LTT in the definitive diagnosis of NPH at the Department of Neurology and Alzheimer’s Disease - National Geriatric Hospital.

An exception-reporting approach for wound swab culture: effect on post-report antibiotic initiation.

Wound swab culture is a high-volume test performed in clinical microbiology laboratories. In this analysis, we have shown that an alternative approach to reporting positive wound swab cultures has resulted in a large reduction in post-report antibiotic initiation, suggesting that the current standard method of reporting generates considerable unnecessary antibiotic use. If these findings are replicated elsewhere, wider adoption of this reporting would represent an opportunity for many clinical microbiology laboratories to have a significant impact on community antimicrobial stewardship.

Surface profile measurement and parameter analysis of silicon wafers in the upright state.

A novel approach, to the best of our knowledge, is presented for assessing silicon wafer surface profiles using an interferometer and vertically rotatable wafer holder. This approach significantly enhances precision and reduces costs, and outperforms traditional techniques in measurement consistency and accuracy. It effectively reduces sample distortion and positional shifts owing to the removal and reinstallation of the wafers. Using this method, a global backsurface-referenced ideal range of 0.385µm, warp of 0.193µm, and other parameters were obtained, demonstrating its practicality in efficiently capturing key surface profile metrics for silicon wafers. This innovation promises substantial improvements in high-volume wafer surface profile testing, overcoming prevalent technological challenges in this industry.

Study on the application of colloidal gold and other immunological tools in the detection of common viruses

To briefly describe the current status of research on colloidal gold and other immunoassay techniques in the detection of common viruses. To understand the principles of colloidal gold technology and other common immunoassay techniques, and the existing clinical applications of enzyme-linked immunosorbent assay (ELISA), polymerase chain reaction (PCR) technology and chemiluminescence immunoassay. We screened and searched for four representative common viruses that have certain social impacts on human beings: novel coronavirus (abbreviated as new coronavirus, COVID-19), rabies virus, human immunodeficiency virus (HIV), and porcine circovirus, and compared them to draw the advantages of colloidal gold and other immunological methods in virus detection. Results In the detection of the four common viruses, colloidal gold technology, compared with other detection methods, uniformly demonstrated the advantages of easy operation, higher specificity, faster detection speed, and the ability to achieve high-volume on-site testing. Colloidal gold technology as a new in vitro detection technology, compared with other detection technologies, is innovative, fast, more accurate results, while the operation is simple, users do not need much training to use correctly. It can be used in clinical testing to achieve rapid, high-volume screening, and can also be used as a simple device to achieve self-testing, assisting medical personnel in clinical diagnosis, which has good social benefits.

B-097 Storage Stability of HbA1c in Whole Blood Tubes at Room Temperature on the Abbott Alinity c Clinical Chemistry System

Abstract Background Hospital laboratories frequently receive requests to order additional tests on an existing specimen. For this reason, laboratories routinely save specimens after initial testing has been completed for a defined period of time. The current literature lacks specific information regarding HbA1c stability in whole blood and the effects of red blood cell settling. In addition, literature references are not inclusive of various conditions which can cause gaps in data collection such as samples in queue for prolonged periods. To obtain information on prolonged storage of whole blood tubes, HbA1c was assessed for storage at room temperature (RT) (20–25°C) for up to 4 hours on the Alinity c system. In addition, potential carryover from a whole blood to a serum sample was assessed. Methods A minimum of 40 whole blood sample pools (approx. 8 mLs) were prepared from remnant samples. Sample pools were mixed, aliquoted, and stored at RT on the Alinity c system. The samples were tested as a single replicate continuously for up to 4 hours without mixing (minimum of 20 cycles) and compared to the baseline sample values. Carryover from a whole blood to a glucose serum sample was assessed after 4 hours continuous testing of whole blood to mimic a high volume testing laboratory. The stability of each HbA1c sample and carryover into a glucose sample were evaluated by comparing the mean absolute or percent difference from the respective sample baseline measurement. The allowed deviation from baseline was 5%. Results After 4 hours at RT, the whole blood cells had settled to approximately 50% from the top of the tube. The red blood cell settling had no significant impact on the results. Within sample precision for the 20 cycles of repetitive testing was </ = 1%. The 48 individual samples showed insignificant difference from the baseline value, with a mean change of 1.0% (Range 0–3.2%). Sample carryover from the whole blood samples to a serum glucose sample was not significant (2.71 Baseline vs 2.64 first replicate). Conclusion This study demonstrated that the storage stability of HbA1c is stable for up to 4 hours at RT on the Alinity c system.

Design and fabrication of a low-cost microfluidic cartridge with integrated pressure-driven check valve for molecular diagnostics platforms

This paper describes the design, fabrication, and preliminary testing of a low-cost, easy to manufacture microfluidics cartridge capable of fluid storage and manipulation through a custom pressure-driven check valve. Cartridge components are fabricated using a desktop CNC and laser cutter, the check valve is fabricated using PDMS in a custom acrylic mold, and the components are assembled using a thermal diffusion welder. Following assembly, preliminary testing of the cartridge, including fluid manipulation and use for molecular diagnostics, was performed. To pull a sample into the lysing chamber, a vacuum over 1.4PSI was required. No opening of the valve to the reaction chamber was observed. Moving fluid across the custom valve from the lysing chamber to the reaction chamber then required a vacuum over 4.5PSI. Finally, a proof-of-concept demonstration of one potential application was performed using a custom benchtop LAMP system for molecular diagnostic testing. The low-cost nature of the design, ease of manufacturing, fluid storage and manipulation demonstrated make this design ideal for research and high-volume testing in low resource environments.

Simultaneous screening for COVID-19 and tuberculosis, India.

To evaluate the implementation of new operational workflows for simultaneous screening of coronavirus disease 2019 (COVID-19) and tuberculosis at four high-volume COVID-19 testing centres located in tertiary hospitals in Mumbai, India. Each centre already offering antigen-detecting rapid diagnostic tests were equipped with a rapid molecular testing platform for COVID-19 and tuberculosis, sufficient laboratory staff, and reagents and consumables for screening. Using a verbal tuberculosis questionnaire, a patient follow-up agent screened individuals visiting the COVID-19 testing centres. Presumptive tuberculosis patients were asked to provide sputum samples for rapid molecular testing. Subsequently, we reversed our operational workflow to also screen patients visiting tuberculosis outpatient departments for COVID-19, using rapid diagnostic tests. From March to December 2021, we screened 14 588 presumptive COVID-19 patients for tuberculosis, of whom 475 (3.3%) were identified as having presumptive tuberculosis. Of these, 288 (60.6%) were tested and 32 individuals (11.1%) were identified as tuberculosis positive (219 cases per 100 000 individuals screened). Of the tuberculosis-positive individuals, three had rifampicin-resistant tuberculosis. Among the remaining 187 presumptive tuberculosis cases not tested, 174 reported no symptoms at follow-up and 13 individuals either refused testing or could not be traced. Of the 671 presumptive tuberculosis cases screened for COVID-19, 17 (2.5%) were positive by antigen rapid diagnostic tests, and five (0.7%) who tested negative, later tested positive on the molecular testing platform (2483 COVID-19 cases per 100 000 individuals screened). Simultaneous screening for COVID-19 and tuberculosis in India is operationally feasible and can improve real-time on-site detection of COVID-19 and tuberculosis.

A Public Health Laboratory Information System in Support of Health Emergencies: The Nebraska Public Health Laboratory COVID-19 Experience.

Public health laboratories (PHLs) are essential components of US Public Health Service operations. The health information technology that supports PHLs is central to effective and efficient laboratory operations and overall public health response to infectious disease management. This analysis presents key information on how the Nebraska Public Health Laboratory (NPHL) information technology system evolved to meet the demands of the COVID-19 pandemic. COVID-19 presented numerous, unforeseen information technology system challenges. The most notable challenges requiring changes to NPHL software systems and capability were improving efficiency of the laboratory operation due to high-volume testing, responding daily to demands for timely data for analysis by partner systems, interfacing with multiple testing (equipment) platforms, and supporting community-based specimen collection programs. Improvements to the NPHL information technology system enabled NPHL to perform >121 000 SARS-CoV-2 polymerase chain reaction tests from March 2020 through January 2022 at a sustainable rate of 2000 SARS-CoV-2 tests per day, with no increase in laboratory staffing. Electronic reporting of 62 000 rapid antigen tests eliminated paper reporting and extended testing services throughout the state. Collection of COVID-19 symptom data before specimen collection enabled NPHL to make data-driven decisions to perform pool testing and conserve testing kits when supplies were low. NPHL information technology applications proved essential for managing health care provider workload, prioritizing the use of scarce testing supplies, and managing Nebraska's overall pandemic response. The NPHL experience provides useful examples of a highly capable information technology system and suggests areas for additional attention in the PHL environment, including a focus on end users, collaboration with various partners, and investment in information technology.

Ultra-sensitive specific detection of nucleic acids in pathogenic infections by Ta2C-MXene sensitization-based ultrafine plasmon spectroscopy combs

Accurate and rapid population-scale screening techniques based on SARS-CoV-2 RNA are essential in preventing and controlling the COVID-19 epidemic. However, the sensitivity and specificity of the assay signal are challenged by the problems of target dilution and sample contamination inherent in high-volume pooled testing. Here, we reported a collaborative system of high-loaded hybrid probes targeting N and OFR1a coupling with the novel Ta2C-M/Au/TFBG biosensor, providing high-intensity vector signals for detecting SARS-CoV-2. The method relies on a segmental modification approach to saturable modify multiple activation sites of SARS-CoV-2 on the high-performance Ta2C-M surface. The coupling of multi-site synergy with composite excited TFBG results in excellent signal transduction, detection limits (0.2 pg/mL), and hybridization efficiency. Without relying on amplification, the collaborative system achieved specific differentiation of 30 clinical samples in an average diagnostic time of 1.8 min. In addition, for the first time, a kinetic determination of dilution mixed samples was achieved and showed a high-intensity carrier signal and fantastic stability. Therefore, it can be used as a collaborative, integrated tool to play a massive role in the screening, prevention, and control of COVID-19 and other epidemics.

A comprehensive review and clinical guide to molecular and serological diagnostic tests and future development: In vitro diagnostic testing for COVID-19

Abstract COVID-19 is a contagious syndrome caused by SARS Coronavirus 2 (SARS-CoV-2) that requires rapid diagnostic testing to identify and manage in the affected persons, characterize epidemiology, and promptly make public health decisions and manage the virus present in the affected person and promptly make public health decisions by characterizing the epidemiology. Technical problems, especially contamination occurring during manual real-time polymerase chain reaction (RT-PCR), can result in false-positive NAAT results. In some cases, RNA detection technology and antigen testing are alternatives to RT-PCR. Sequencing is vital for tracking the SARS-CoV-2 genome’s evolution, while antibody testing is beneficial for epidemiology. SARS-CoV-2 testing can be made safer, faster, and easier without losing accuracy. Continued technological advancements, including smartphone integration, will help in the current epidemic and prepare for the next. Nanotechnology-enabled progress in the health sector has aided disease and pandemic management at an early stage. These nanotechnology-based analytical tools can be used to quickly diagnose COVID-19. The SPOT system is used to diagnose the coronavirus quickly, sensibly, accurately, and with portability. The SPOT assay consists of RT-LAMP, followed by pfAgo-based target sequence detection. In addition, SPOT system was used to detect both positive and negative SARS-CoV-2 samples. This combination of speed, precision, sensitivity, and mobility will allow for cost-effective and high-volume COVID-19 testing.

Deicing performance of common deicing agents for winter maintenance with and without corrosion-inhibiting substances

Sodium chloride (SC) is by far the most cost-effective deicing agent in winter road maintenance and therefore is used by road authorities worldwide. However, chloride ions foster high corrosivity, which significantly reduces the service lifetime of metals and reinforced concrete of transport infrastructures. Hence, a holistic evaluation with the main criteria of deicing performance and corrosion is demanded and, if possible, alternatives should be considered.This paper focuses on the deicing performance of sodium chloride and other common acetate-, carbonate-, chloride- and formate-based deicing agents. A newly developed test method is presented, enabling high volume testing at good repeatability. From its results a nonlinear model is derived to predict deicing performance up to five hours after application. Subsequently, this model is compared with both existing empirical and theoretical approaches for evaluating the deicing performance. In addition, the impact of added corrosion-inhibiting substances like sugars on deicing performance is investigated. Finally, a comparison of all tested substances in terms of corrosivity and deicing performance is presented, with corrosion being investigated in detail in another paper.

Implementation of a Telehealth Genetic Testing Station to Deliver Germline Testing for Men With Prostate Cancer.

Germline testing for men with prostate cancer (PCa) poses numerous implementation barriers. Alternative models of care delivery are emerging, but implementation outcomes are understudied. We evaluated implementation outcomes of a hybrid oncologist- and genetic counselor-delivered model called the genetic testing station (GTS) created to streamline testing and increase access. A prospective, single-institution, cohort study of men with PCa referred to the GTS from October 14, 2019, to October 14, 2021, was conducted. Using the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework, we described patients referred to GTS (Reach), the association of GTS with germline testing completion rates within 60 days of a new oncology appointment in a pre- versus post-GTS multivariable logistic regression (Effectiveness), Adoption, Implementation, and Maintenance. Because GTS transitioned from an on-site to remote service during the COVID-19 pandemic, we also compared outcomes for embedded versus remote GTS. Overall, 713 patients were referred to and eligible for GTS, and 592 (83%) patients completed germline testing. Seventy-six (13%) patients had ≥ 1 pathogenic variant. Post-GTS was independently associated with higher odds of completing testing within 60 days than pre-GTS (odds ratio, 8.97; 95% CI, 2.71 to 29.75; P < .001). Black race was independently associated with lower odds of testing completion compared with White race (odds ratio, 0.35; 95% CI, 0.13 to 0.96; P = .042). There was no difference in test completion rates or patient-reported decisional conflict for embedded versus remote GTS. GTS has been adopted by 31 oncology providers across four clinics, and implementation fidelity was high with low patient loss to follow-up, but staffing costs are a sustainability concern. GTS is a feasible, effective model for high-volume germline testing in men with PCa, both in person and using telehealth. GTS does not eliminate racial disparities in germline testing access.

Maturing pharmacogenomic factors deliver improvements and cost efficiencies.

An ever-expanding annotation of the human genome sequence continues to promise a new era of precision medicine. Advances in knowledge management and the ability to leverage genetic information to make clinically relevant, predictive, diagnostic, and targeted therapeutic choices offer the ability to improve patient outcomes and reduce the overall cost of healthcare. However, numerous barriers have resulted in a modest start to the clinical use of genetics at scale. Examples of successful deployments include oncologic disease treatment with targeted prescribing; however, even in these cases, genome-informed decision-making has yet to achieve standard of care in most major healthcare systems. In the last two decades, advances in genetic testing, therapeutic coverage, and clinical decision support have resulted in early-stage adoption of pharmacogenomics - the use of genetic information to routinely determine the safety and efficacy profile of specific medications for individuals. Here, through their complicated histories, we review the current state of pharmacogenomic testing technologies, the information tools that can unlock clinical utility, and value-driving implementation strategies that represent the future of pharmacogenomics-enabled healthcare decision-making. We conclude with real-world economic and clinical outcomes from a full-scale deployment and ultimately provide insight into potential tipping points for global adoption, including recent lessons from the rapid scale-up of high-volume test delivery during the global SARS-CoV2 epidemic.

Pooling samples to increase testing capacity with Xpert Xpress SARS-CoV-2 during the Covid-19 pandemic in Lao People's Democratic Republic.

The COVID-19 pandemic created the need for large-scale testing of populations. However, most laboratories do not have sufficient testing capacity for mass screening. We evaluated pooled testing of samples, as a strategy to increase testing capacity in Lao PDR. Samples of consecutive patients were tested in pools of four using the Xpert Xpress SARS CoV-2 assay. Positive pools were confirmed by individual testing, and we describe the performance of the test and savings achieved. We also diluted selected positive samples to describe its effect on the assays CT values. 1,568 patients were tested in 392 pools of four. 361 (92.1%) pools were negative and 31 (7.9%) positive. 29/31 (93.5% (95%CI 77-99%) positive pools were confirmed by individual testing of the samples but, in 2/31 (6.5%) the four individual samples were negative, suggesting contamination. Pools with only one positive sample had higher CT values (lower RNA concentrations) than the respective individual samples, indicating a dilution effect, which suggested an increased risk of false negative results with dilutions >1:10. However, this risk may be low if the prevalence of infection is high, when pools are more likely to contain more than one positive sample. Pooling saved 67% of cartridges and substantially increased testing capacity. Pooling samples increased SARS-CoV-2 testing capacity and resulted in considerable cartridge savings. Given the need for high-volume testing, countries may consider implementation of pooling for SARS-CoV-2 screening.

Clinical Outcomes After Ventriculo-Peritoneal Shunting in Patients With Classic vs. Complex NPH

ObjectiveNormal pressure hydrocephalus (NPH) is a neurological condition characterized by a clinical triad of gait disturbance, cognitive impairment, and urinary incontinence in conjunction with ventriculomegaly. Other neurodegenerative diseases, such as Alzheimer's disease, Parkinson's disease, and vascular dementia share some overlapping clinical features. However, there is evidence that patients with comorbid NPH and Alzheimer's or Parkinson's disease may still exhibit good clinical response after CSF diversion. This study aims to evaluate clinical responses after ventriculo-peritoneal shunt (VPS) in a cohort of patients with coexisting NPH and neurodegenerative disease.MethodsThe study has two components; (i) a pilot study was performed that specifically focused upon patients with Complex NPH and following the inclusion of the Complex NPH subtype into consideration for the clinical NPH programme, (ii) a retrospective snapshot study was performed to confirm and characterize differences between Classic and Complex NPH patients being seen consecutively over the course of 1 year within a working subspecialist NPH clinic. We studied the characteristics of patients with Complex NPH, utilizing clinical risk stratification and multimodal biomarkers.ResultsThere was no significant difference between responders and non-responders to CSF diversion on comorbidity scales. After VPS insertion, significantly more Classic NPH patients had improved cognition compared to Complex NPH patients (p = 0.005). Improvement in gait and urinary symptoms did not differ between the groups. 26% of the Classic NPH group showed global improvement of the triad, and 42% improved in two domains. Although only 8% showed global improvement of the triad, all Complex NPH patients improved in gait.ConclusionsOur study has demonstrated that the presence of neurodegenerative disorders co-existing with NPH should not be the sole barrier to the consideration of high-volume tap test or lumbar drainage via a specialist NPH programme. Further characterization of distinct cohorts of NPH with differing degrees of CSF responsiveness due to overlay from neurodegenerative or comorbidity risk burden may aid toward more precise prognostication and treatment strategies. We propose a simplistic conceptual framework to describe NPH by its Classic vs. Complex subtypes to promote the clinical paradigm shift toward subspecialist geriatric neurosurgery by addressing needs for rapid screening tools at the clinical-research interface.

Clinical Validation of a Rapid Variant-Proof RT-RPA Assay for the Detection of SARS-CoV-2.

The COVID-19 pandemic has unveiled a pressing need to expand the diagnostic landscape to permit high-volume testing in peak demand. Rapid nucleic acid testing based on isothermal amplification is a viable alternative to real-time reverse transcription polymerase chain reaction (RT-PCR) and can help close this gap. With the emergence of SARS-CoV-2 variants of concern, clinical validation of rapid molecular tests needs to demonstrate their ability to detect known variants, an essential requirement for a robust pan-SARS-CoV-2 assay. To date, there has been no clinical validation of reverse transcription recombinase polymerase amplification (RT-RPA) assays for SARS-CoV-2 variants. We performed a clinical validation of a one-pot multi-gene RT-RPA assay with the E and RdRP genes of SARS-CoV-2 as targets. The assay was validated with 91 nasopharyngeal samples, with a full range of viral loads, collected at University College London Hospitals. Moreover, the assay was tested with previously sequenced clinical samples, including eleven lineages of SARS-CoV-2. The rapid (20 min) RT-RPA assay showed high sensitivity and specificity, equal to 96% and 97%, respectively, compared to gold standard real-time RT-PCR. The assay did not show cross-reactivity with the panel of respiratory pathogens tested. We also report on a semi-quantitative analysis of the RT-RPA results with correlation to viral load equivalents. Furthermore, the assay could detect all eleven SARS-CoV-2 lineages tested, including four variants of concern (Alpha, Beta, Delta, and Omicron). This variant-proof SARS-CoV-2 assay offers a significantly faster and simpler alternative to RT-PCR, delivering sensitive and specific results with clinical samples.

The Impact of Total Automaton on the Clinical Laboratory Workforce: A Case Study.

BackgroundThere has been a significant concern that total automation can decrease the need for laboratory personnel at all levels. The objective of this study was to investigate the impact of total laboratory automation on the clinical laboratory workforce.MethodsA one-year data including the demographical features of laboratory workforce and technical productivity of laboratory tests were provided by two medical laboratory departments of similar profile and different equipment setup; one adopting a total automation system and the other utilizing discrete analysis system. The technical productivities of the two laboratories were compared and statistically tested.ResultsA similar technical productivity per single laboratory worker was noted in the hematology section in each of the two sites with no significant difference (average odd radio = 0.9, p = 0.79). However, with total automation, the number of tests performed per single worker has increased to an average of 1.4 and 3.7 times with total automation in the clinical chemistry and serology sections, respectively (p ≤ 0.001).ConclusionTotal laboratory automation improves the productivity of the laboratory, leading to a decreased laboratory workforce. The laboratory workload has increased steadily therefore, the existing laboratory workforce, in the absence of automation, could not have been able to maintain the current volume of service. Adoption of automation reduces repetitive manual labor, thereby allowing the redefinition of the job roles of the laboratory workforce. TLA is ideal for laboratories that suffer from workforce shortages or managing high volume testing with less staff.

A Flow Cytometry-Based Assay for the Measurement of Total Complement Activity in the Serum and Clinical Practice.

Objective To develop a novel sensitive and accurate assay suitable for high-volume testing of the total complement activity in the serum for clinical laboratories. Methods The total complement activity (TCA) to be measured was quantified by detecting the number of fragments produced by erythrocyte lysis and the erythrocyte fragmentation index (EFI), indicating TCA. EFI = M × M2/(M1 + M2), where M is the number of erythrocyte fragments (removed from the background), M1 is the number of unagglutinated red cells, M2 is the number of agglutinated red cell groups, and M2/(M1 + M2) is the agglutination coefficient indicating the degree of erythrocyte agglutination. Mild changes in hemolysin and erythrocyte concentrations were made to optimize the testing conditions. The same serum samples were tested for 10 consecutive days to determine the stability of the experimental results. Serum EFI was detected in both nephrotic syndrome patients and healthy subjects. Results There was a linear relationship between hemolysin and erythrocyte agglutination (r = 0.999, P < 0.001). A good linear relationship existed between EFI and TCA (r = 0.991, P < 0.001). The results were not affected by slight fluctuations in the concentrations of hemolysin or erythrocytes. The interbatch CV = 8.6% of the test results showed good stability. There was a significant difference in the EFI between nephrotic syndrome patients and healthy individuals, P < 0.001, and EFI was reduced in nephrotic syndrome patients compared to healthy individuals. Conclusion The flow cytometry-based assay for TCA was sensitive and accurate and had potential value for clinical application.

Implementation and Accuracy of BinaxNOW Rapid Antigen COVID-19 Test in Asymptomatic and Symptomatic Populations in a High-Volume Self-Referred Testing Site.

ABSTRACTRapid antigen tests are simple to perform and provide results within 15 min. We describe our implementation and assess performance of the BinaxNOW COVID-19 Antigen Test (Abbott Laboratories) in 6,099 adults at a self-referred walk-up testing site. Participants were grouped by self-reported COVID-19 exposure and symptom status. Most (89%) were asymptomatic, of whom 17% reported potential exposure. Overall test sensitivity compared with reference laboratory reverse-transcription [RT] PCR testing was 81% (95% confidence interval [CI] 75%, 86%). It was higher in symptomatic (87%; 95% CI 80%, 91%) than asymptomatic (71%; 95% CI 61%, 80%) individuals. Sensitivity was 82% (95% CI 66%, 91%) for asymptomatic individuals with potential exposure and 64% (95% CI 51%, 76%) for those with no exposure. Specificity was greater than 99% for all groups. BinaxNOW has high accuracy among symptomatic individuals and is below the FDA threshold for emergency use authorization in asymptomatic individuals. Nonetheless, rapid antigen testing quickly identifies positive among those with symptoms and/or close contact exposure and could expedite isolation and treatment.IMPORTANCE The BinaxNOW rapid antigen COVID-19 test had a sensitivity of 87% in symptomatic and 71% asymptomatic individuals when performed by health care workers in a high-throughput setting. The performance may expedite isolation decisions or referrals for time-sensitive monoclonal antibody treatment in communities where timely COVID PCR tests are unavailable.