Performance Evaluation: Four Chemiluminescent SARS-Cov-2 Immunoassays and Rapid-Card Test in Mild Disease and Seroprevalence of SARS CoV-2 in Frontline Healthcare Workers

Introduction: The COVID-19 pandemic raised a host of challenges to modern medicine. Key amongst these were in diagnostics, as most SARS-CoV-2 assays had been rapidly developed and released under emergency-use authorization with limited validation on clinical samples and secondly, an increased risk of COVID-19 infection to healthcare workers (HCW). There are limited inter-assay comparisons to detect SARS-CoV-2 antibodies in cases with milder symptoms of COVID-19, necessary to evaluate whether assays can detect SARS-CoV-2 antibodies in patients with mild infection. Aim: Therefore this study aimed to evaluate the performance of four chemiluminescence immunoassays and a rapid immunochromatographic assay in 100 rRT-PCR diagnosed-recovered frontline HCW with milder COVID-19 disease and secondly to evaluate the seroprevalence of SARS-CoV-2 infection in the asymptomatic frontline HCW at a multispeciality hospital in Delhi, India. Study Design: Serum and plasma samples were obtained from 100 rRT-PCR diagnosed-recovered frontline HCWs with mild disease working across the hospital, and performance of four common chemiluminescence immunoassays evaluated. Also samples of 505 asymptomatic, frontline HCWs working in hospital, who had not developed or shown any symptoms of COVID-19 infection to date was collected and the seroprevalence of infection was evaluated. Place and Duration of the Study: A study was conducted at BLK Superspeciality Hospital, New Delhi from September to October 2020. Methods: Four chemiluminescence immunoassays [Abbott SARS-CoV-2 IgG (Nucleocapsid), Roche Elecsys® Anti-SARS-CoV-2 Total (Nucleocapsid), Ortho-Clinical Diagnostics: VITROS Anti-SARS-CoV-2 IgG (Spike) and Anti-SARS-CoV-2 Total (Spike)] and a rapid assay [Medsource Ozone Biomedicals] were evaluated in 100 rRT-PCR diagnosed-recovered frontline HCW with mild disease. Also, seroprevalence was studied in 505 asymptomatic, frontline HCW. Results: At manufacturers' thresholds, overall sensitivity for Abbott was 71%, Roche 96%, Ortho (both total and IgG(S) 99% and rapid card 56%. Seroprevalence in asymptomatic frontline HCW was found to be 17.6%, with positivity being higher in the HCW group not facing patients directly compared to direct patient caregivers (P = 0.0034). Conclusion: Assay performance depends on assay design (total IgM & IgG antibodies versus IgG alone), choice of antigen, and time of sample testing from the onset of disease. In our study, Ortho Vitros total-Ab; IgG (Spike), and Roche Elecsys total-Ab (Nucleocapsid) assays were found to have optimal sensitivity. A seroprevalence study in the frontline HCWs at our institute showed that seroprevalence was higher (17.6%) in HCWs in comparison to the community.

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Distinct SARS-CoV-2 Antibody Reactivity Patterns in Coronavirus Convalescent Plasma Revealed by a Coronavirus Antigen Microarray

10.1101/2020.09.16.300871 ◽

2020 ◽

Author(s):

Rafael Assis ◽

Aarti Jain ◽

Rie Nakajima ◽

Algis Jasinskas ◽

Saahir Khan ◽

...

Keyword(s):

Neutralization Assay ◽

Clinical Diagnostics ◽

Antibody Reactivity ◽

High Concordance ◽

And Performance ◽

The Individual ◽

Ortho Clinical Diagnostics ◽

Preclinical And Clinical Studies ◽

Antibody Levels ◽

Cutoff Threshold

AbstractA coronavirus antigen microarray (COVAM) was constructed containing 11 SARS-CoV-2, 5 SARS-1, 5 MERS, and 12 seasonal coronavirus recombinant proteins. The array is designed to measure immunoglobulin isotype and subtype levels in serum or plasma samples against each of the individual antigens printed on the array. We probed the COVAM with COVID-19 convalescent plasma (CCP) collected from 99 donors who recovered from a PCR+ confirmed SARS-CoV-2 infection. The results were analyzed using two computational approaches, a generalized linear model (glm) and Random Forest (RF) prediction model, to classify individual specimens as either Reactive or Non-Reactive against the SARS-CoV-2 antigens. A training set of 88 pre-COVID-19 specimens (PreCoV) collected in August 2019 and102 positive specimens from SARS-CoV-2 PCR+ confirmed COVID-19 cases was used for these analyses. Results compared with an FDA emergency use authorized (EUA) SARS-CoV2 S1-based total Ig chemiluminescence immunoassay (Ortho Clinical Diagnostics VITROS® Anti-SARS-CoV-2 Total, CoV2T) and with a SARS-CoV-2 S1-S2 spike-based pseudovirus micro neutralization assay (SARS-CoV-2 reporter viral particle neutralization titration (RVPNT) showed high concordance between the 3 assays. Three CCP specimens that were negative by the VITROS CoV2T immunoassay were also negative by both COVAM and the RVPNT assay. Concordance between VITROS CoV2T and COVAM was 96%, VITROS CoV2T and RVPNT 93%, and RVPNT and COVAM 95%. The discordances were all weakly reactive samples near the cutoff threshold of the VITROS CoV2T immunoassay. The multiplex COVAM allows CCP to be grouped according to antibody reactivity patterns against 11 SARS-CoV-2 antigens. Unsupervised K-means analysis, via the gap statistics, as well as hierarchical clustering analysis revealed 3 main clusters with distinct reactivity intensities and patterns. These patterns were not recapitulated by adjusting the VITROS CoV2T or RVPNT assay thresholds. Plasma classified according to these reactivity patterns may be better associated with CCP treatment efficacy than antibody levels alone. The use of a SARS-CoV-2 antigen array may be useful to qualify CCP for administration as a treatment for acute COVID-19 and to interrogate vaccine immunogenicity and performance in preclinical and clinical studies to understand and recapitulate antibody responses associated with protection from infection and disease.

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504. Transmission of SARS-CoV-2 to Household Members of COVID Positive Healthcare Workers

Open Forum Infectious Diseases ◽

10.1093/ofid/ofaa439.697 ◽

2020 ◽

Vol 7 (Supplement_1) ◽

pp. S317-S318

Author(s):

Mehreen Arshad ◽

Sebastian Otero ◽

Leena B Mithal

Keyword(s):

Stress Level ◽

Healthcare Workers ◽

Preventive Measures ◽

Physical Contact ◽

Transmission Risk ◽

Infection Prevention And Control ◽

Intimate Contact ◽

Mild Disease ◽

Increased Risk ◽

Survey Responses

Abstract Background Healthcare workers (HCW) are at increased risk of SARS-CoV-2 infection. Infection prevention and control methods to prevent HCWs from bringing the virus home are lacking. We aimed to describe the various isolation practices of COVID positive (+) physicians and advanced practice providers to mitigate transmission risk to family members (FM) and understand HCW stress during this pandemic. Methods Survey responses were collected from 5/19/2020 - 6/12/2020 using a convenience sampling of HCW. Solicitations were done through email, listservs, institutional websites, and Facebook groups without geographic restriction. We collected data on demographics, details about HCW illness, health of FM, preventive measures taken, and HCW stress. Results The survey has so far been completed by 51 COVID+ respondents with FM in the home (Table 1). Half (55%) work in outpatient, 31% inpatient, and 8% in ER setting. Most HCW (83%) were diagnosed by PCR test; others were presumptive positive due to symptoms and exposure (14%). 64% had mild disease and 33% had moderate disease. Most common preventive measures were immediate showering after reaching home (59%) and changing clothes prior to going home (35%); 22% took no precautions. About 55% of FM developed symptoms of COVID. There were no significant differences between preventive measures taken by HCW whose FM remained asymptomatic. However, we noted that HCW whose FM remained symptom-free were more likely to sleep in a separate room (17% vs. 7%), refrain from physical contact with FM (22% vs.14%) and intimate contact with partners (22% vs. 11%). Over 88% reported increased stress level, many identifying health concerns and safety (26%) and impact on FM (28%) as the greatest source of stress. There was no difference in reported stress level between HCW whose FM became infected and those who were not. HCW with symptom-free FM were more concerned about transmission to their partner (p = 0.02). Table 1 Table 2 Conclusion This is the first survey of its kind which, although limited by total respondents, indicates that HCW are taking a variety of approaches to prevent transmission of SARS-CoV-2 to their FM. We did not find a significant impact of individual preventive measures on the risk of transmission. Regardless of the FM illness, most HCW have increased stress due to impact of COVID. Disclosures All Authors: No reported disclosures

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Distinct SARS-CoV-2 antibody reactivity patterns in coronavirus convalescent plasma revealed by a coronavirus antigen microarray

Scientific Reports ◽

10.1038/s41598-021-87137-7 ◽

2021 ◽

Vol 11 (1) ◽

Author(s):

Rafael Assis ◽

Aarti Jain ◽

Rie Nakajima ◽

Algis Jasinskas ◽

Saahir Khan ◽

...

Keyword(s):

Generalized Linear Model ◽

Neutralization Assay ◽

Clinical Diagnostics ◽

Training Set ◽

Antibody Reactivity ◽

High Concordance ◽

And Performance ◽

The Individual ◽

Ortho Clinical Diagnostics ◽

Cutoff Threshold

AbstractA coronavirus antigen microarray (COVAM) was constructed containing 11 SARS-CoV-2, 5 SARS-1, 5 MERS, and 12 seasonal coronavirus recombinant proteins. The array is designed to measure immunoglobulin isotype and subtype levels in serum or plasma samples against each of the individual antigens printed on the array. We probed the COVAM with COVID-19 convalescent plasma (CCP) collected from 99 donors who recovered from a PCR+ confirmed SARS-CoV-2 infection. The results were analyzed using two computational approaches, a generalized linear model (glm) and random forest (RF) prediction model, to classify individual specimens as either Reactive or non-reactive against the SARS-CoV-2 antigens. A training set of 88 pre-COVID-19 specimens (PreCoV) collected in August 2019 and102 positive specimens from SARS-CoV-2 PCR+ confirmed COVID-19 cases was used for these analyses. Results compared with an FDA emergency use authorized (EUA) SARS-CoV2 S1-based total Ig chemiluminescence immunoassay (Ortho Clinical Diagnostics VITROS Anti-SARS-CoV-2 Total, CoV2T) and with a SARS-CoV-2 S1-S2 spike-based pseudovirus micro neutralization assay (SARS-CoV-2 reporter viral particle neutralization titration (RVPNT) showed high concordance between the three assays. Three CCP specimens that were negative by the VITROS CoV2T immunoassay were also negative by both COVAM and the RVPNT assay. Concordance between VITROS CoV2T and COVAM was 96%, VITROS CoV2T and RVPNT 93%, and RVPNT and COVAM 91%. The discordances were all weakly reactive samples near the cutoff threshold of the VITROS CoV2T immunoassay. The multiplex COVAM allows CCP to be grouped according to antibody reactivity patterns against 11 SARS-CoV-2 antigens. Unsupervised K-means analysis, via the gap statistics, as well as hierarchical clustering analysis revealed three main clusters with distinct reactivity intensities and patterns. These patterns were not recapitulated by adjusting the VITROS CoV2T or RVPNT assay thresholds. Plasma classified by COVAM reactivity patterns offers potential to improve CCP therapeutic efficacy CoV2T alone. The use of a SARS-CoV-2 antigen array can qualify CCP for administration as a treatment for acute COVID-19, and interrogate vaccine immunogenicity and performance in preclinical, clinical studies, and routine vaccination to identify antibody responses predictive of protection from infection and disease.

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Study of sharp injuries and blood splash exposures among healthcare workers in a tertiary hospital in Bangalore

International Journal of Infection Control ◽

10.3396/ijic.v12i3.016.16 ◽

2016 ◽

Vol 12 (3) ◽

Author(s):

Shalini Sivananjiah Pradeep ◽

Suman Gadicherla Raghu ◽

Prathab A G ◽

Banashankari G Rudresh ◽

Radhika Kunnavil

Keyword(s):

Healthcare Workers ◽

Tertiary Hospital ◽

Post Exposure Prophylaxis ◽

Care Hospital ◽

Post Exposure ◽

Increased Risk ◽

Management Procedures ◽

Exposure Prophylaxis ◽

Sharps Injury ◽

Sharps Injuries

The working environment of healthcare workers (HCW) exposes them to sharp injuries. This communication attempts to examine the injury registers, incidence of sharps injuries and blood splash exposures, and the post-exposure prophylaxis status of employees in a tertiary care hospital. Analysis included records form 54 locations of two units of a tertiary hospital attached to a Medical College. Maintenance of the injury register overall was highly satisfactory in both units. Two hundred and nine injuries were recorded from both units of the hospital. The majority of injuries (60.5%) occurred in the age group of 20-30 years with 70% among females. Waste handlers were at increased risk during waste management procedures. Thirty two percent of sharps injury injuries occurred in wards. Of the ward nursing staff, 25.3% received sharps injuries. Post-exposure prophylaxis for Hepatitis B (primary dose) was given to 25 HCWs; 11 received booster doses. The basic regimen for HIV post-exposure prophylaxis was given to 4 HCWs. Awareness about records maintenance, regular documentation, awareness and training, and implementation of appropriate preventive measures can reduce the incidence of injuries. Key words: Sharps, injury register, Health care workers (HCW),Post exposure prophylaxis (PEP)

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SARS-CoV-2 seroprevalence and asymptomatic viral carriage in healthcare workers: a cross-sectional study

Thorax ◽

10.1136/thoraxjnl-2020-215414 ◽

2020 ◽

Vol 75 (12) ◽

pp. 1089-1094 ◽

Cited By ~ 22

Author(s):

Adrian Shields ◽

Sian E Faustini ◽

Marisol Perez-Toledo ◽

Sian Jossi ◽

Erin Aldera ◽

...

Keyword(s):

Intensive Care ◽

Healthcare Workers ◽

Venous Blood ◽

Cross Sectional Study ◽

Nasopharyngeal Swab ◽

Sectional Study ◽

University Hospitals ◽

Cross Sectional ◽

General Internal ◽

Increased Risk

ObjectiveTo determine the rates of asymptomatic viral carriage and seroprevalence of SARS-CoV-2 antibodies in healthcare workers.DesignA cross-sectional study of asymptomatic healthcare workers undertaken on 24/25 April 2020.SettingUniversity Hospitals Birmingham NHS Foundation Trust (UHBFT), UK.Participants545 asymptomatic healthcare workers were recruited while at work. Participants were invited to participate via the UHBFT social media. Exclusion criteria included current symptoms consistent with COVID-19. No potential participants were excluded.InterventionParticipants volunteered a nasopharyngeal swab and a venous blood sample that were tested for SARS-CoV-2 RNA and anti-SARS-CoV-2 spike glycoprotein antibodies, respectively. Results were interpreted in the context of prior illnesses and the hospital departments in which participants worked.Main outcome measureProportion of participants demonstrating infection and positive SARS-CoV-2 serology.ResultsThe point prevalence of SARS-CoV-2 viral carriage was 2.4% (n=13/545). The overall seroprevalence of SARS-CoV-2 antibodies was 24.4% (n=126/516). Participants who reported prior symptomatic illness had higher seroprevalence (37.5% vs 17.1%, χ2=21.1034, p<0.0001) and quantitatively greater antibody responses than those who had remained asymptomatic. Seroprevalence was greatest among those working in housekeeping (34.5%), acute medicine (33.3%) and general internal medicine (30.3%), with lower rates observed in participants working in intensive care (14.8%). BAME (Black, Asian and minority ethnic) ethnicity was associated with a significantly increased risk of seropositivity (OR: 1.92, 95% CI 1.14 to 3.23, p=0.01). Working on the intensive care unit was associated with a significantly lower risk of seropositivity compared with working in other areas of the hospital (OR: 0.28, 95% CI 0.09 to 0.78, p=0.02).Conclusions and relevanceWe identify differences in the occupational risk of exposure to SARS-CoV-2 between hospital departments and confirm asymptomatic seroconversion occurs in healthcare workers. Further investigation of these observations is required to inform future infection control and occupational health practices.

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Safer primary healthcare facilities are needed to protect healthcare workers and maintain essential services: lessons learned from a multicountry COVID-19 emergency response initiative

BMJ Global Health ◽

10.1136/bmjgh-2021-005833 ◽

2021 ◽

Vol 6 (6) ◽

pp. e005833

Author(s):

Leena N Patel ◽

Samantha Kozikott ◽

Rodrigue Ilboudo ◽

Moreen Kamateeka ◽

Mohammed Lamorde ◽

...

Keyword(s):

Health Facility ◽

Healthcare Workers ◽

National Level ◽

Lessons Learned ◽

Health Facilities ◽

Infection Prevention And Control ◽

Health Facility Level ◽

Ensure Patient Safety ◽

Increased Risk ◽

Facility Level

Healthcare workers (HCWs) are at increased risk of infection from SARS-CoV-2 and other disease pathogens, which take a disproportionate toll on HCWs, with substantial cost to health systems. Improved infection prevention and control (IPC) programmes can protect HCWs, especially in resource-limited settings where the health workforce is scarcest, and ensure patient safety and continuity of essential health services. In response to the COVID-19 pandemic, we collaborated with ministries of health and development partners to implement an emergency initiative for HCWs at the primary health facility level in 22 African countries. Between April 2020 and January 2021, the initiative trained 42 058 front-line HCWs from 8444 health facilities, supported longitudinal supervision and monitoring visits guided by a standardised monitoring tool, and provided resources including personal protective equipment (PPE). We documented significant short-term improvements in IPC performance, but gaps remain. Suspected HCW infections peaked at 41.5% among HCWs screened at monitored facilities in July 2020 during the first wave of the pandemic in Africa. Disease-specific emergency responses are not the optimal approach. Comprehensive, sustainable IPC programmes are needed. IPC needs to be incorporated into all HCW training programmes and combined with supportive supervision and mentorship. Strengthened data systems on IPC are needed to guide improvements at the health facility level and to inform policy development at the national level, along with investments in infrastructure and sustainable supplies of PPE. Multimodal strategies to improve IPC are critical to make health facilities safer and to protect HCWs and the communities they serve.

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Role of occupational therapy in musicians’ health: a scoping review protocol

BMJ Open ◽

10.1136/bmjopen-2020-040922 ◽

2020 ◽

Vol 10 (12) ◽

pp. e040922

Author(s):

Bethany Villas ◽

Uira Duarte Wisnesky ◽

Sandra Campbell ◽

Lauren Slavik ◽

Amynah S. Mevawala ◽

...

Keyword(s):

Occupational Therapy ◽

Scoping Review ◽

Health Conditions ◽

Study Selection ◽

Increased Risk ◽

Scoping Reviews ◽

Review Protocol ◽

And Performance ◽

Meta Analyses

Review question/objectiveThe purpose of this proposed review is twofold: first, to understand the role of occupational therapy presented in the musicians’ health literature; and second, to explore the potential for this role.IntroductionThe intense movement, awkward postures, concentration and emotional communication required of musicians can place them at increased risk of music-related health conditions, such as musculoskeletal disorders and performance anxiety. The development of music-related health conditions can be emotionally and financially devastating. The role of occupational therapy in musicians’ health has been previously discussed; however, no rigorous reviews of the scholarly literature have been published. We will, therefore, undertake a scoping review with the following research questions: (1) what is known about the role of occupational therapy in instrumental musicians’ health? and (2) what is the potential role of occupational therapy in musicians’ health?Methods and analysisA preliminary search of Medline, CINAHL, SCOPUS and Web of Science was previously undertaken by the first author to determine the extent of the research on this topic and to confirm that no other reviews have been conducted or are in progress. Study selection and analysis will follow the Joanna Briggs Institute and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for scoping reviews guidelines for conducting a scoping review.Ethics and disseminationFormal ethics approval is not required at our institution for a review of published literature. The results of this review will be shared through peer-reviewed publications, conference presentations and traditional and social media.

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Eastern Cape Healthcare Workers Acquisition of SARS-CoV-2 (ECHAS): Cross-Sectional (Nested Cohort) Study Protocol

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph18010323 ◽

2021 ◽

Vol 18 (1) ◽

pp. 323

Author(s):

Oladele Vincent Adeniyi ◽

David Stead ◽

Mandisa Singata-Madliki ◽

Joanne Batting ◽

Leo Hyera ◽

...

Keyword(s):

Cohort Study ◽

Infection Rate ◽

Healthcare Workers ◽

Health Facilities ◽

Control Measures ◽

Infection Prevention And Control ◽

Eastern Cape ◽

Rt Pcr ◽

Cross Sectional ◽

Increased Risk

Healthcare workers (HCWs) are at increased risk of infection by the virulent severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2). Though data exist on the positivity rate of the SARS-CoV-2 reverse transcription polymerase chain reaction (RT-PCR) test as well as COVID-19-related deaths amongst HCWs in South Africa, the overall infection rate remains underestimated by these indicators. It is also unclear whether the humoral immune response after SARS-CoV-2 infection offers durable protection against reinfection. This study will assess the SARS-CoV-2 seroprevalence amongst HCWs in the Eastern Cape (EC) and examine the longitudinal changes (rate of decay) in the antibody levels after infection in this cohort. Using a multi-stage cluster sampling of healthcare workers in selected health facilities in the EC, a cross-sectional study of 2250 participants will be recruited. In order to assess the community infection rate, 750 antenatal women in the same settings will be recruited. Relevant demographic and clinical characteristics will be obtained by a self-administered questionnaire. A chemiluminescent microparticle immunoassay (CMIA) will be used for the qualitative detection of IgG antibodies against SARS-CoV-2 nucleocapsid protein. A nested cohort study will be conducted by performing eight-weekly antibody assays (X2) from 201 participants who tested positive for both SARS-CoV-2 RT-PCR and serology. Logistic regression models will be fitted to identify the independent risk factors for SARS-CoV-2 infection. The cumulative SARS-CoV-2 infection rate and infection fatality rate among the frontline HCWs will be estimated. In addition, the study will highlight the overall effectiveness of infection prevention and control measures (IPC) per exposure sites/wards at the selected health facilities. Findings will inform the South African Department of Health’s policies on how to protect HCWs better as the country prepares for the second wave of the SARS-CoV pandemic.

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Analytical assessment of ortho clinical diagnostics high-sensitivity cardiac troponin I assay

Clinical Chemistry and Laboratory Medicine (CCLM) ◽

10.1515/cclm-2020-1115 ◽

2020 ◽

Vol 0 (0) ◽

Author(s):

Peter A. Kavsak ◽

Tara Edge ◽

Chantele Roy ◽

Paul Malinowski ◽

Karen Bamford ◽

...

Keyword(s):

Cardiac Troponin ◽

Troponin I ◽

Limit Of Detection ◽

Clinical Performance ◽

Characteristic Curve ◽

Area Under The Curve ◽

High Sensitivity ◽

Cardiac Troponin I ◽

Clinical Diagnostics ◽

Ortho Clinical Diagnostics

AbstractObjectivesTo analytically evaluate Ortho Clinical Diagnostics VITROS high-sensitivity cardiac troponin I (hs-cTnI) assay in specific matrices with comparison to other hs-cTn assays.MethodsThe limit of detection (LoD), imprecision, interference and stability testing for both serum and lithium heparin (Li-Hep) plasma for the VITROS hs-cTnI assay was determined. We performed Passing-Bablok regression analyses between sample types for the VITROS hs-cTnI assay and compared them to the Abbott ARCHITECT, Beckman Access and the Siemens ADVIA Centaur hs-cTnI assays. We also performed Receiver-operating characteristic curve analyses with the area under the curve (AUC) determined in an emergency department (ED)-study population (n=131) for myocardial infarction (MI).ResultsThe VITROS hs-cTnI LoD was 0.73 ng/L (serum) and 1.4 ng/L (Li-Hep). Stability up to five freeze-thaws was observed for the Ortho hs-cTnI assay, with the analyte stability at room temperature in serum superior to Li-Hep with gross hemolysis also affecting Li-Hep plasma hs-cTnI results. Comparison of Li-Hep to serum concentrations (n=202), yielded proportionally lower concentrations in plasma with the VITROS hs-cTnI assay (slope=0.85; 95% confidence interval [CI]:0.83–0.88). In serum, the VITROS hs-cTnI concentrations were proportionally lower compared to other hs-cTnI assays, with similar slopes observed between assays in samples frozen <−70 °C for 17 years (ED-study) or in 2020. In the ED-study, the VITROS hs-cTnI assay had an AUC of 0.974 (95%CI:0.929–0.994) for MI, similar to the AUCs of other hs-cTn assays.ConclusionsLack of standardization of hs-cTnI assays across manufacturers is evident. The VITROS hs-cTnI assay yields lower concentrations compared to other hs-cTnI assays. Important differences exist between Li-Hep plasma and serum, with evidence of stability and excellent clinical performance comparable to other hs-cTn assays.

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Evaluation of the ARKRAY HA-8190V instrument for HbA1c

Clinical Chemistry and Laboratory Medicine (CCLM) ◽

10.1515/cclm-2020-1300 ◽

2020 ◽

Vol 0 (0) ◽

Author(s):

Eline A.E. van der Hagen ◽

Sanne Leppink ◽

Karin Bokkers ◽

Carla Siebelder ◽

Cas W. Weykamp

Keyword(s):

Quality Assessment ◽

Concentration Level ◽

External Quality Assessment ◽

Clinical Samples ◽

Diabetic Patients ◽

External Quality ◽

Target Values ◽

Performance Specifications ◽

Certification Programme ◽

And Performance

Abstract Objectives Hemoglobin A1c (HbA1c) is a valuable parameter in the monitoring of diabetic patients and increasingly in diagnosis of diabetes. Manufacturers continuously optimize instruments, currently the main focus is to achieve faster turnaround times. It is important that performance specifications remain of high enough standard, which is evaluated in this study for the new ARKRAY HA-8190V instrument. Methods The Clinical and Laboratory Standards Institute (CLSI) protocols EP-5, EP-9 and EP-10 were applied to investigate imprecision, bias and linearity. In addition potential interferences, performance in External Quality Assessment (EQA) and performance against the HA-8180V instrument in 220 clinical samples was evaluated. Results The HA-8190V demonstrates a CV of ≤0.8% in IFCC SI units (≤0.6% National Glycohemoglobin Standardization Program [NGSP]) at 34 and 102 mmol/mol levels (5.3 and 11.5% NGSP) and a bias of −0.1 mmol/mol (−0.01% NGSP) at a concentration of 50 mmol/mol (6.7% NGSP), but with a significant slope as compared to target values. This results in a bias of −1.0 and 0.9 mmol/mol (−2.0 and 0.9% NGSP) at the 30 and 70 mmol/mol (4.9 and 8.6% NGSP) concentration level. Simulation of participation in the IFCC certification programme results in a Silver score (bias −0.1 mmol/mol, CV 1.1%). Interference in the presence of the most important Hb variants (AS, AC, AE, AD) and elevated HbA2 and HbF concentrations is less than 3 mmol/mol (0.3% NGSP) at a concentration of 50 mmol/mol (6.7% NGSP). Conclusions Analytical performance of the HA-8190V is very good, especially with respect to precision and HbA1c quantification in the presence of the most common Hb variants.

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