Prevention of mother-to-child transmission of hepatitis B virus: An observation of routine practice in a tertiary liver centre before and after the introduction of the global health sector strategy on viral hepatitis.

INTRODUCTION: Worldwide, around 296 million people have hepatitis B virus (HBV) infection, most commonly transmitted from mother-to-child. Global Health Sector Strategy on Viral Hepatitis (GHSSVH) was introduced in May 2016, calling for elimination of viral hepatitis by 2030. This study aims to compare practice in a tertiary liver centre before and after GHSSVH introduction for prevention of mother-to-child transmission (MTCT). MATERIALS AND METHODS: This retrospective cohort study was performed in a tertiary referral liver centre in Malaysia, using data from electronic medical record from January 2015 to December 2019. A total of 1457 medical records of female with HBV infection were screened. The inclusion criteria of the study were pregnant women with HBsAg positive or known to have HBV infection during the study period. We excluded patients with co-infections of other types of viral hepatitis or human immunodeficiency virus, concurrent liver diseases (e.g.: autoimmune hepatitis, Wilson's disease), previous organ transplant and malignancy­except for hepatocellular carcinoma (HCC). RESULTS: This study included 117 pregnancies and 21/117 (17.9%) were on antiviral therapy (AVT) for HBV. In 2017­ 2019, 13/18 (72.2%) of those with HBV DNA >200,000IU/ml were on AVT, compared to 5/9 (55.6%) for 2015­2016, indicating 58% (95% CI −63% to 568%) higher odds of being on AVT in post GHSSVH group after accounting for HBV DNA. CONCLUSION: Uptake of maternal AVT for the prevention of MTCT shows an increased trend since the introduction of GHSSVH, with room for improvement.

Bioequivalence and pharmacokinetic comparison of two fixed dose combination of Metformin/ Glibenclamide formulations in healthy subjects under fed condition.

AIM: This study is conducted to compare the pharmacokinetic profiles of two fixed dose combination of metformin/glibenclamide tablets (500mg/5 mg per tablet). MATERIALS AND METHODS: This is a single-center, single-dose, open-label, randomized, 2-treatment, 2-sequence and 2- period crossover study with a washout period of 7 days. All 28 adult male subjects were required to fast for at least 10 hours prior to drug administration and they were given access to water ad libitum during this period. Thirty minutes prior to dosing, all subjects were served with a standardized high-fat and high-calorie breakfast with a total calorie of 1000 kcal which was in accordance to the EMA Guideline on the Investigation of Bioequivalence. Subsequently, subjects were administered either the test or reference preparation with 240mL of plain water in the first trial period. During the second trial period, they received the alternate preparation. Plasma levels of glibenclamide and metformin were analysed separately using two different high performance liquid chromatography methods. RESULTS: The 90% confidence interval (CI) for the ratio of the AUC0-t, AUC0-∞, and Cmax of the test preparation over those of the reference preparation were 0.9693-1.0739, 0.9598- 1.0561 and 0.9220 - 1.0642 respectively. Throughout the study period, no serious drug reaction was observed. However, a total of 26 adverse events (AE)/side effects were reported, including 24 that were definitely related to the study drugs, namely giddiness (n=17), while diarrheoa (n=3), headache (n=2) and excessive hunger (n=2) were less commonly reported by the subjects. CONCLUSION: It can be concluded that the test preparation is bioequivalent to the reference preparation.

The present and future disease burden of hepatitis C virus infections with today's treatment paradigm: Volume 4.

Factors influencing the morbidity and mortality associated with viremic hepatitis C virus (HCV) infection change over time and place, making it difficult to compare reported estimates. Models were developed for 17 countries (Bahrain, Bulgaria, Cameroon, Colombia, Croatia, Dominican Republic, Ethiopia, Ghana, Hong Kong, Jordan, Kazakhstan, Malaysia, Morocco, Nigeria, Qatar and Taiwan) to quantify and characterize the viremic population as well as forecast the changes in the infected population and the corresponding disease burden from 2015 to 2030. Model inputs were agreed upon through expert consensus, and a standardized methodology was followed to allow for comparison across countries. The viremic prevalence is expected to remain constant or decline in all but four countries (Ethiopia, Ghana, Jordan and Oman); however, HCV-related morbidity and mortality will increase in all countries except Qatar and Taiwan. In Qatar, the high-treatment rate will contribute to a reduction in total cases and HCV-related morbidity by 2030. In the remaining countries, however, the current treatment paradigm will be insufficient to achieve large reductions in HCV-related morbidity and mortality.

The clinical features and treatment outcome of chronic hepatitis C with pegylated interferon and ribavirin in routine care.

AIM: To describe the clinical characteristic of hepatitis C (HCV) patients and the results of pegylated interferon and ribavirin (PegIFN/RBV) therapy in a routine clinical practice. METHODS: A retrospective review of consecutive HCV patients treated with PegIFN/RBV in 2004 to 2012. RESULTS: A total of 273 patients received treatment. The mean age was 44.16 ± 10.5 years and 76% were male. The top 2 self-reported risks were blood or blood product transfusion before 1994 and injection drug use, found in 57.1% of patients. The predominant HCV genotype (GT) was 3 at 60.6%, second was GT1 at 36.1% and other GTs were uncommon at about 1% or less. About half of our patients have high baseline viral load (>800,000 iu/ml), 18.3% had liver cirrhosis and 22.3% had HIV co-infection. Co-morbid illness was found in 42.9%, hypertension and type 2 diabetes were the two most common. The overall sustained virological response (SVR) by intention-to-treat analysis were 54.9% (n=150/273), 41.2% (40/97) for GT1, 100% (5/5) for GT2 and 62% (101/163) for GT3. Subgroup analysis for HCV monoinfected, treatment naïve showed SVR of 49.2% (31/63) for GT1, 100% (5/5) for GT2 and 67% (69/103) for GT3. In HCV mono-infected and treatment experienced (n=29), the SVR was 28.6% (4/14) for GT1, 21.4% (69/103) for GT3. In the HIV/HCV co-infected, treatment naïve (n=56), the SVR was 28.6% (4/14) for GT1 and 64.3% (27/42) for GT3. Treatment naïve GT3 mono-infected patients had a statistically significant higher SVR compared to treatment experienced patients (P=0.001). In GT3 patients who achieved rapid virological response, the SVR was significantly higher at 85.2% (P< 0.001). The SVR for cirrhotics were low especially for GT1 at 21% (4/19) and 31% (4/13) based on all patients and treatment naïve HCV monoinfected respectively. In GT3 cirrhotics the corresponding SVR were 57.1% (16/28) and 60.9% (14/23). Premature discontinuation rate was 21.2% with the majority due to intolerable adverse events at 12.1%. CONCLUSIONS: In our routine clinical practice, the HCV patients we treated were young, predominantly of GT3 and many had difficult-to-treat clinical characteristics. The SVR of our patients were below those reported in Asian clinical trials but in keeping with some "real world" data.

Cost-utility of exercise therapy in patients with hip osteoarthritis in primary care.

OBJECTIVE: To determine the cost-effectiveness (CE) of exercise therapy (intervention group) compared to 'general practitioner (GP) care' (control group) in patients with hip osteoarthritis (OA) in primary care. METHOD: This cost-utility analysis was conducted with 120 GPs in the Netherlands from the societal and healthcare perspective. Data on direct medical costs, productivity costs and quality of life (QoL) was collected using standardised questionnaires which were sent to the patients at baseline and at 6, 13, 26, 39 and 52 weeks follow-up. All costs were based on Euro 2011 cost data. RESULTS: A total of 203 patients were included. The annual direct medical costs per patient were significantly lower for the intervention group (€ 1233) compared to the control group (€ 1331). The average annual societal costs per patient were lower in the intervention group (€ 2634 vs € 3241). Productivity costs were higher than direct medical costs. There was a very small adjusted difference in QoL of 0.006 in favour of the control group (95% CI: -0.04 to +0.02). CONCLUSION: Our study revealed that exercise therapy is probably cost saving, without the risk of noteworthy negative health effects. TRIAL REGISTRATION NUMBER: NTR1462.

¹8F-FDG PET/CT in inflammation of unknown origin: a cost-effectiveness pilot-study.

PURPOSE: Patients with increased inflammatory parameters, nonspecific signs and symptoms without fever and without a diagnosis after a variety of diagnostic procedures are a diagnostic dilemma and are referred to as having inflammation of unknown origin (IUO). The objective of this pilot study was to compare the cost-effectiveness of a diagnostic work-up/strategy with and without (18)F-FDG PET/CT in patients with IUO using a published dataset as a reference. METHODS: IUO patients without (18)F-FDG PET/CT (group A, 46 patients) and IUO patients referred for (18)F-FDG PET/CT (group B, 46 patients) were selected. IUO was defined as the combination of nonspecific signs and symptoms and a prolonged erythrocyte sedimentation rate (ESR), defined as ≥age/2 in men and ≥(age + 10)/2 in women (ESR in millimetres per hour and age in years), and/or C-reactive protein (CRP) ≥15 mg/l. The costs of all tests and procedures and the number of hospitalization days in each patient to reach a diagnosis were calculated using current Dutch tariffs. RESULTS: In group A a diagnosis was reached in 14 of the 46 patients. The mean cost per patient of all the diagnostic procedures was 2,051, and including the cost of hospitalization was 12,614. In group B a diagnosis was reached in 32 of the 46 patients. The mean cost per patient of all the diagnostic procedures was 1,821, significantly lower than in group A (p < 0.0002), and including the cost of hospitalization was 5,298. CONCLUSION: In IUO (18)F-FDG PET/CT has the potential to become a cost-effective routine imaging technique indicating the direction for further diagnostic decisions thereby allowing unnecessary, invasive and expensive diagnostic investigations to be avoided and possibly the duration of hospitalization to be reduced. However, a prospective multicentre "bottom-up microcosting" cost-effectiveness study is warranted before these preliminary data can be extrapolated to clinical practice.

Real-world resource use and costs of adjuvant treatment for stage III colon cancer.

Since the generalisability of trial-based economic evaluations may be limited, there is an increasing focus on real-world cost-effectiveness. Real-world studies involve evaluating the effects and costs of treatments in daily clinical practice. This study reports on the real-world resource use and costs of adjuvant treatments of stage III colon cancer in a population-based observational study. Analyses were based on a detailed retrospective medical chart review which was conducted for 206 patients with colon cancer treated in 2005 and 2006 in the Netherlands. Mean total costs per patient were €9681 for 5-FU/LV, €9736 for capecitabine, €32,793 for FOLFOX and €18,361 for CAPOX. Drug costs and the costs related to hospitalisations for chemotherapy administration were the main cost drivers. We identified a potential for substantial cost-savings when the 48 h administration of 5FU/LV in the FOLFOX regimen were to take place in an outpatient setting or be replaced by oral capecitabine as in the CAPOX regimen. This analysis based on detailed real-life data clearly indicates that clinical choices made in oncology based on efficacy of therapy have economic consequences. Considering today's reality of finite healthcare resources, these economic consequences deserve a formal role in clinical decision making, for instance in guideline development.

Treating hepatitis C in HIV/HCV co-infected patients in Malaysia - the outcomes and challenges.

BACKGROUND: Co-infection by human immunodeficiency and hepatitis C viruses (HIV/HCV) is common and results in significant morbidity and mortality despite effective antiretroviral therapies (ART). METHOD: A retrospective and prospective evaluation of the efficacy and safety of pegylated interferon alfa 2a/2b plus ribavirin (PEG-IFN/RBV) in consecutive HIV/HCV co-infected patients treated in real life clinical practice in Malaysia. RESULTS: Forty-five HIV/HCV co-infected patients with a median age (interquartile range, IQR) of 41 years (37; 47) were assessed for treatment with PEG-IFN/RBV. All except one are of male gender and the most common risk behaviour was injecting drug use. At baseline 75.5% was on ART and the median (IQR) CD4 count was 492 cells/µl (376; 621). The HCV genotypes (GT) were 73 % GT3 and 27% GT1. Liver biopsies in forty patients showed 10% had liver cirrhosis and another 50% had significant liver fibrosis. The treatment completion rate was 79.5% with 15.9% dropped out of treatment due to adverse effects (AE) or default and 4.6% due to lack of early virological response. The AE causing premature discontinuations were neuropsychiatric and haematological. The overall sustained virological response (SVR) was 63.6% with a trend towards higher SVR in GT3 compared with GT1 (71.9% vs. 41.7%; p=0.064). In patients with bridging fibrosis plus occasional nodules or cirrhosis on liver biopsy, the SVR was significantly lower at 20% (p=0.030) compared to those with milder fibrosis. CONCLUSION: HIV/HCV co-infected patients can be successfully and safely treated with PEG-IFN/RBV achieving high rates of SVR except in cirrhotic patients.

APASL clinical practice guidelines on the management of acute kidney injury in acute-on-chronic liver failure.

Acute-on-chronic liver failure (ACLF) is a syndrome that is characterized by the rapid development of organ failures predisposing these patients to a high risk of short-term early death. The main causes of organ failure in these patients are bacterial infections and systemic inflammation, both of which can be severe. For the majority of these patients, a prompt liver transplant is still the only effective course of treatment. Kidneys are one of the most frequent extrahepatic organs that are affected in patients with ACLF, since acute kidney injury (AKI) is reported in 22.8-34% of patients with ACLF. Approach and management of kidney injury could improve overall outcomes in these patients. Importantly, patients with ACLF more frequently have stage 3 AKI with a low rate of response to the current treatment modalities. The objective of the present position paper is to critically review and analyze the published data on AKI in ACLF, evolve a consensus, and provide recommendations for early diagnosis, pathophysiology, prevention, and management of AKI in patients with ACLF. In the absence of direct evidence, we propose expert opinions for guidance in managing AKI in this very challenging group of patients and focus on areas of future research. This consensus will be of major importance to all hepatologists, liver transplant surgeons, and intensivists across the globe.

Significance of relaxin-2 expression in hepatocellular carcinoma: relation with clinicopathological parameters.

BACKGROUND: A number of putative roles, including the modulation of tumor growth, neovascularization, metastasis and oncogenic progression, have been correlated to relaxin-2 overexpression. However, the clinical significance of relaxin-2 expression in hepatocellular carcinoma (HCC) remains unclear. The aim of this study was to investigate the expression of relaxin-2 in HCC and determine its correlation with tumor progression and prognosis. PATIENTS AND METHODS: 180 HCC patients who had undergone curative liver resection were selected and immunohistochemistry was performed to analyze relaxin-2 expression in the respective tumors. RESULTS: Immunohistochemistry confirmed relaxin-2 overexpression in HCC tissues compared with their adjacent nonneoplastic tissues (p < 0.01). Additionally, immunostaining showed more relaxin-2 positive cells in the higher tumor grade (III) than in the lower tumor stage (I, II; p = 0.026). Moreover, HCC patients with high relaxin-2 expression were significantly associated with lower 5-year overall survival (p < 0.01) and lower 5-year disease-free survival (p < 0.01), respectively. Furthermore, immunostaining showed more relaxin-2 positive cells in the tumor recurrence (ETR) patients than non-ETR patients (p = 0.001). The Cox proportional hazards model further showed that relaxin-2 was an independent poor prognostic factor for both 5-year disease-free survival (hazards ratio [HR] = 1.872, 95% confidence interval [CI] = 1.18-5.146, p = 0.023) and 5-year overall survival (HR = 3.637, CI = 1.443-7.15, p = 0.001) in HCC. CONCLUSIONS: Our data suggest for the first time that the overexpression of relaxin-2 protein in HCC tissues is of predictive value on tumor progression and poor prognosis.

Real-world health care costs of relapsed/refractory multiple myeloma during the era of novel cancer agents.

WHAT IS KNOWN AND OBJECTIVE: High costs of novel agents increasingly put pressure on limited healthcare budgets. Demonstration of their real-world costs and cost-effectiveness is often required for reimbursement. However, few published economic evaluations of novel agents for multiple myeloma exist. Moreover, existing cost analyses were heavily based on conventionally treated patients. We investigated real-world health care costs of relapsed/refractory multiple myeloma in Dutch daily practice. METHODS: A retrospective medical chart review was conducted for 139 patients treated between January 2001 and May 2009. Total monthly costs attributable to each cost component were described across all regimens and for bortezomib-, thalidomide- and lenalidomide-based treatment regimens. RESULTS: Mean monthly total costs (€3,981) varied depending on the sequence of therapy (range: €442-€31,318). Significant cost drivers across all regimens included costs of therapy and hospital admissions. The acquisition costs for novel agents in particular accounted for 32% of mean total monthly costs. Prognostic factors associated with increased mean total monthly costs in multivariate regression analysis included low platelet counts (P = 0·01) and worsening performance status (P < 0·001). Mean total monthly costs of bortezomib- and lenalidomide-based regimens were significantly higher than those for thalidomide-based regimens in second, third and fourth treatment line. WHAT IS NEW AND CONCLUSIONS: Real-world costs during treatment of relapsed/refractory multiple myeloma vary greatly. Cost drivers include hospital admissions and acquisition costs of novel agents. Costs also vary by prognostic factors and treatment-related resource use. Future studies assessing the costs of combination therapy consisting of two or more novel agents are encouraged.

X-chromosome inactivation occurs at different times in different tissues of the post-implantation mouse embryo.

During mammalian development, one of the two X chromosomes in female embryos is randomly inactivated in the somatic cell in order to achieve gene dosage compensation. But is X inactivation established simultaneously or is it accomplished over time in a lineage-dependent fashion? We have examined this question in mouse embryos carrying an X-linked lacZ transgene. This transgene is subject to inactivation and the loss of beta-galactosidase activity provides a direct indication of X inactivation in individual cells. We find that X inactivation proceeds with different schedules in different somatic tissues, and the notochord, the heart, cranial mesoderm and the hindgut are among the last tissues to undergo X inactivation.

Treatment costs of acute myocardial infarction in the Netherlands.

BACKGROUND: This study aimed to calculate the treatment costs of acute myocardial infarction (AMI) in the Netherlands for 2012. Also, the degree of association between treatment costs of AMI and some patient and hospital characteristics was examined. METHODS: For this retrospective cost analysis, patients were drawn from the database of the Diagnosis Treatment Combination (Diagnose Behandeling Combinatie, DBC) casemix system, which contains data on the resource use of all hospitalisations in the Netherlands. All costs were based on Euro 2012 cost data. RESULTS: The analysis was based on data of 25,657 patients. Mean treatment costs were estimated at 5021, with significant cost increases for patients with percutaneous coronary intervention (PCI) treatment. ST-segment elevation myocardial infarction (STEMI) patients receiving thrombolysis incurred the lowest ( 4286), while non-STEMI patients receiving PCI the highest costs ( 6060). Length of stay and hospital type were strong predictors of treatment costs. CONCLUSIONS: This study is the most extensive cost assessment of the treatment costs of AMI in the Netherlands thus far. Our results may be used as input for health-economic models and economic evaluations to support the decision making of registration, reimbursement and pricing of interventions in healthcare.

Concurrent massive breast enlargement, myasthenia gravis and dermopathy as manifestations of penicillamine toxicity in a Wilson's disease patient.

Penicillamine toxicity in Wilson's disease has been well reported but rarely seen now as newer agents are being used. We present a case who developed multiple rare complications of Penicillamine concurrently. Our patient is one of three siblings on Penicillamine, she was the only one who developed massive breast enlargement four months after commencing Penicillamine therapy, as well as dermatological adverse reactions and myasthenia gravis three more months later. All the adverse effects improved soon after substitution of the offending agent with Trientine.

Upregulated FGFR1 expression is associated with the transition of hormone-naive to castrate-resistant prostate cancer.

BACKGROUND: Prostate cancer (PC) represents a global health issue. Treatment for locally advanced and metastatic PC remains unsatisfactory. The androgen receptor (AR) has been validated in having a key role in both naïve and castrate-resistant PC (CRPC). However, the significance of other signalling pathways in CRPC is less well validated. METHODS: To gain a better insight into the molecular signalling cascades involved in clinical CRPC, we performed gene expression profiling using the Illumina DASL assay and studied matched hormone-naive (HN) and CR prostate tumours (n=10 pairs). Ingenuity Pathways Analysis (IPA) was used to identify potential networks involved, and further validation was performed in in vitro cell models and clinical tumours. RESULTS: Expression of 50 genes was significantly different between HN and CRPC. IPA revealed two networks of particular interest, including AR and FGFR1, respectively. FGFR1 expression was confirmed to be significantly upregulated in CRPC (P ≤ 0.005), and abnormal FGFR1 expression was associated with shorter time to biochemical relapse in HNPC (P=0.006) and less favourable disease-specific survival in CRPC (P=0.018). CONCLUSION: For the first time, our gene expression profiling experiment on archival tumour materials has identified upregulated FGFR1 expression to be associated with PC progression to the CR state.

An autoimmune disease with multiple molecular targets abrogated by the transgenic expression of a single autoantigen in the thymus.

Many autoimmune diseases are characterized by autoantibody reactivities to multiple cellular antigens. Autoantigens are commonly defined as targets of the autoimmune B cell response, but the role, if any, of these autoantigens in T cell-mediated autoimmune diseases is generally unknown. Murine experimental autoimmune gastritis is a CD4+ T cell-mediated organ-specific autoimmune disease induced by neonatal thymectomy of BALB/c mice. The murine disease is similar to human autoimmune gastritis and pernicious anemia, and is characterized by parietal and chief cell loss, submucosal mononuclear cell infiltrates, and autoantibodies to the alpha and beta subunits of the gastric H/K ATPase. However, the specificity of T cells that cause the disease is not known. To examine the role of the H/K ATPase in this T cell-mediated disease, transgenic mice were generated that express the beta subunit of the H/K ATPase under the control of the major histocompatibility complex class II I-Ek alpha promoter. We show that transgenic expression of the gastric H/K ATPase beta subunit specifically prevents the onset of autoimmune gastritis after neonatal thymectomy. In addition, thymocyte transfer experiments suggest that tolerance of pathogenic autoreactive T cells is induced within the thymus of the transgenic mice. We conclude that the beta subunit of the gastric H/K ATPase is a major T cell target in autoimmune gastritis and that thymic expression of a single autoantigen can abrogate an autoimmune response to multiple autoantigens.

Safety and efficacy of an escalating dose regimen of pegylated interferon alpha-2b in the treatment of haemodialysis patients with chronic hepatitis C.

Chronic hepatitis C is associated with increased morbidity and mortality in persons undergoing haemodialysis. This single-arm, open-label clinical trial investigated the safety and efficacy of an escalating dosage regimen of pegylated interferon (PEG-IFN) alpha-2b in this patient population. Patients with chronic hepatitis C who were undergoing haemodialysis began treatment with PEG-IFN alpha-2b at a dose of 0.5 microg/kg/week, which was increased every 4 weeks to a maximum of 1 microg/kg/week. Treatment duration was 24 weeks for patients with genotype (G) 2 or 3 infection and 48 weeks for patients with G1 infection. The primary end point was sustained virological response (SVR). Of 46 patients screened, 34 (G1: 70.6%; G3: 29.4%) were treated and 23 (67.6%) completed treatment. Overall, 85.3% of patients experienced early virological response, 52.9% experienced end-of-treatment response, and 50% attained SVR, with a trend toward higher SVR rates in G3 compared with G1 patients (80%vs 37.5%; P = 0.06). Anaemia was the main reason for discontinuation of treatment. Patients with chronic hepatitis C who are undergoing haemodialysis can be successfully treated with an escalating dosage regimen of PEG-IFN alpha-2b monotherapy. G3-infected patients can attain high rates of SVR with only 24 weeks of therapy.

Cost-utility of exercise therapy in adolescents and young adults suffering from the patellofemoral pain syndrome.

The objective of this paper was to determine the cost effectiveness of exercise therapy (intervention group) compared with "usual care" (control group) in adolescents and young adults with the patellofemoral pain syndrome in primary care. This multicenter prospective randomized clinical trial with cost-utility analysis was conducted at 38 general practices and three sport medical advice centers in the Netherlands for 2007. A total of 131 patients were included. The annual direct medical costs per patient were significantly higher for the intervention group (euro 434) compared with the control group (euro 299) mainly caused by additional physiotherapy visits. The average annual societal costs per patient were significantly lower in the intervention group (euro 1011 vs euro 1.166). Productivity costs were the largest cost component, in particular costs due to reduced efficiency at paid work which were responsible for 47% and 56% of the total costs in the intervention and control group respectively. Patients in the intervention group experienced a slightly, but not significantly, higher quality of life (0.8722 vs 0.8617). With a cost effectiveness ratio of -euro 14,738 per quality adjusted life year, exercise therapy appears to be cost effective as compared with "usual care."

Clinical evaluation of serological IgG antibody response on the Abbott Architect for established SARS-CoV-2 infection.

OBJECTIVE: This study aimed to evaluate the diagnostic performance of the Abbott Architect SARS-CoV-2 IgG assay in COVID-19 patients. METHODS: Residual sera from 177 symptomatic SARS-CoV-2-positive patients and 163 non-COVID-19 patients were tested for antibody with the Abbott SARS-CoV-2 IgG assay (Abbott Diagnostics, Chicago, USA). Clinical records for COVID-19 patients were reviewed to determine the time from onset of clinical illness to testing. RESULTS: Specificity of the assay was 100.0% (95%CI: 97.1-100.0%). The clinical sensitivity of the assay varied depending on time from onset of symptoms, increasing with longer periods from the onset of clinical illness. The clinical sensitivity at ≤6 days was 8.6% (7/81; 95%CI: 3.8-17.5%), at 7-13 days 43.6% (17/39; 95%CI: 28.2-60.2%), at 14-20 days 84.0% (21/25; 95%CI: 63.1-94.7%), and at ≥21 days 84.4% (27/32; 95%CI: 66.5-94.1%). Clinical sensitivity was higher in the ≥14-day group compared to <14 days. There were no differences between the 14-20-day and ≥21-days groups; the combined clinical sensitivity for these groups (≥14 days) was 84.2% (49/57; 71.6-92.1%). CONCLUSION: The Abbott SARS-CoV-2 IgG test has high specificity. Clinical sensitivity was limited in the early stages of disease but improved from 14 days after the onset of clinical symptoms.