scholarly journals Preventive Efficacy of Tenofovir/Emtricitabine Against Severe Acute Respiratory Syndrome Coronavirus 2 Among Pre-Exposure Prophylaxis Users

2020 ◽  
Vol 7 (11) ◽  
Author(s):  
Oskar Ayerdi ◽  
Teresa Puerta ◽  
Petunia Clavo ◽  
Mar Vera ◽  
Juan Ballesteros ◽  
...  
Keyword(s):  
Severe Acute Respiratory Syndrome ◽  
Clinical Manifestations ◽  
Control Group ◽  
Prevention Measures ◽  
Duration Of Symptoms ◽  
Chemiluminescent Microparticle Immunoassay ◽  
Group 2 ◽  
Tenofovir Alafenamide ◽  
Sex With Men ◽  
Exposure Prophylaxis

Abstract Background The preventive effect that tenofovir/emtricitabine (FTC) could have against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in human immunodeficiency virus-negative people is unknown. The objective of this study was to analyze the seroprevalence and clinical manifestations of COVID-19 among users of pre-exposure prophylaxis (PrEP), disoproxil fumarate/FTC (TDF/FTC), or tenofovir alafenamide (TAF)/FTC and to compare it to that of a control group. Methods An observational descriptive study of the seroprevalence of antibodies for SARS-CoV-2 among men who have sex with men and transgender women without use of PrEP (Group 1; n = 250) and PrEP users with TDF/FTC (n = 409) or TAF/FTC (n = 91) (Group 2; n = 500) was conducted from May11, 2020 to June 27, 2020. All participants were provided with a structured questionnaire that collected information on the variables to be analyzed, and testing for immunoglobulin G antibodies to SARS-CoV-2 (chemiluminescent microparticle immunoassay) was then carried out. Results The seroprevalence of SARS-CoV-2 was 9.2% (95% confidence interval [CI], 5.9–13.5) in the group without PrEP and 15.0% (95% CI, 12.0–18.4) in the group with PrEP (P = .026). Among users of TDF/FTC it was 14.7% (95% CI, 11.4–18.5), and in users of TAF/FTC it was 16.5% (95% CI, 9.5–25.7) (P = .661). In those who tested positive for SARS-CoV-2 and receiving PrEP, 57.4% manifested symptoms, compared with 78.3% in the control group (P = .070). In users of TDF/FTC the figure was 53.3% and in users of TAF/FTC the figure was 73.3% (P = .100). The duration of symptoms was 11.5 days in the control group, 9.0 days in PrEP users (P = .116), 7.0 days in users of TDF/FTC, and 13.0 days in users of TAF/FTC (P = .100). Conclusions Users of PrEP, TDF/FTC, or TAF/FTC presented a higher seroprevalence to SARS-CoV-2 than the control group. No statistically significant differences were found in relation to clinical manifestations. The PrEP users should use the same prevention measures as those indicated for the general population.

Role of antioxidant therapy in patients with moderate and severe COVID-19

2021 ◽  
Vol 19 (1) ◽  
pp. 159-164
Author(s):  
E.K. Shavarova ◽  
◽  
E.R. Cazakhmedov ◽  
M.V. Alekseeva ◽  
L.G. Ezhova ◽  
...  
Keyword(s):  
Oxidative Stress ◽  
Intervention Group ◽  
Clinical Manifestations ◽  
Organ Damage ◽  
Control Group ◽  
Reactive Protein ◽  
Virus Rna ◽  
Active Intervention Group ◽  
Group 2 ◽  
Novel Coronavirus

The coronavirus disease COVID-19 is characterized by high mortality and the lack of effective etiotropic therapy. Activation of oxidative stress may be one of the links in the pathogenesis of organ damage of this infection. Objective. To assess the ability of Mexidol® to influence the rate of clinical improvement in pneumonia caused by the SARSCoV-2 virus in hospitalized patients with the novel coronavirus disease COVID-19 and concomitant discirculatory encephalopathy. 62 patients over the age of 18 years with confirmed new coronavirus disease COVID-19 according to computed tomography (CT) of the lungs (stages CT1, CT2, CT3) and PCR of a swab from the nasopharynx and oropharynx for SARS-CoV-2 virus RNA were included. After randomization patients of group 1 received an infusion of Mexidol® at a dose of 1000 mg/day, patients of group 2 – an infusion of isotonic sodium chloride solution for 7 days. Compared with the control group, the patients receiving Mexidol® therapy showed a significantly more pronounced decrease in body temperature, a tendency towards a decrease in the severity of shortness of breath. In the Mexidol® group, the concentration of superoxidedismutase did not change, while in the control group there was a tendency to its decrease, C-reactive protein decreased 2.2 times more than in the control group (p = 0.09). There was a tendency for a more rapid decrease in ferritin in the active intervention group. Mexidol® therapy can have a positive effect on the clinical manifestations and severity of laboratory-inflammatory syndrome in patients with the new coronavirus disease COVID-19. Key words: coronavirus disease COVID-19, oxidative stress, Mexidol

scholarly journals Effects of Ginger on clinical manifestations and paraclinical features of patients with Severe Acute Respiratory Syndrome due to COVID-19: A structured summary of a study protocol for a randomized controlled trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Omid Safa ◽  
Mehdi Hassaniazad ◽  
Mehdi Farashahinejad ◽  
Parivash Davoodian ◽  
Habib Dadvand ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Severe Acute Respiratory Syndrome ◽  
Pharmaceutical Company ◽  
Standard Treatment ◽  
Clinical Manifestations ◽  
Control Group ◽  
Exclusion Criteria ◽  
Positive Polymerase Chain Reaction ◽  
Gi Symptoms ◽  
Full Protocol

Abstract Objectives We investigate the effects of Ginger, compared to the usual therapeutic regimen on clinical manifestations and paraclinical features in patients with confirmed COVID-19 that are moderately ill. Trial design This is a single center, randomized, double-blind, placebo-controlled clinical trial with parallel group design. Participants Inclusion criteria: 1. Patients admitted to Severe Acute Respiratory Syndrome (SARS) Departments at Shahid Mohammadi Hospital, Bandar Abbas, Iran 2. Age ≥18 years (weight ≥35 kg) 3. Hospitalized ≤48 hours 4. Confirmed SARS-CoV-2 diagnosis (Positive polymerase chain reaction (PCR)) 5. Moderate pneumonia and lung involvement in imaging 6. Signing informed consent and willingness of study participant to accept randomization to any assigned treatment arm Exclusion criteria: 1. Underlying diseases, including heart disease, chronic hypertension, severe renal failure, severe liver failure, and thyroid disorders 2. Use of warfarin, selective serotonin reuptake inhibitors (SSRIs), monoamine oxidase inhibitors (MAOIs), diuretics, corticosteroids, and antiarrhythmic drugs 3. Severe and critical pneumonia 4. History of known allergy to Ginger 5. Pregnancy and breastfeeding Intervention and comparator Intervention group: The standard treatment regimen for COVID-19 along with Ginger-based herbal tablets (Vomigone ®, Dineh Pharmaceutical Company, Iran) at a dose of 1000 mg three times a day for a period of seven days. Control group: The standard treatment for COVID-19 based on the Iranian Ministry of Health and Medical Education's protocol, along with Vomigone-like placebo tablets (Dineh Pharmaceutical Company, Iran) at a dose of two tablets three times a day for a period of seven days. Main outcomes The primary outcome is recovery rate of clinical symptoms, including fever, dry cough, tiredness, and GI symptoms as well as paraclinical features, including thrombocytopenia, lymphocytopenia, and C-reactive protein within seven days of randomization. Time to improvement of clinical and paraclinical features along with the incidence of serious adverse events are the secondary outcomes within seven days of randomization. Randomization An interactive web-based system will be used to allocate eligible participants, based on the inclusion and exclusion criteria, to one of the two study arms (in a 1:1 ratio) using block randomization. Blinding (masking) All study participants, research coordinators, clinicians, nurses, and investigators will be blinded to the group assignment. Numbers to be randomized (sample size) A total of 84 participants will be randomized into two groups of 42 patients. Trial Status The protocol is Version 1.0, May 23, 2020. Recruitment began July 21, 2020, and is anticipated to be completed by October 30, 2020. Trial registration This clinical trial has been registered in the Iranian Registry of Clinical Trials (IRCT). The registration number is “IRCT20200506047323N1”. Registration date is 23 May 2020. Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.

scholarly journals COVID-19 in Hospitalized Adults With HIV

2020 ◽  
Vol 7 (8) ◽  
Author(s):  
Kate Stoeckle ◽  
Carrie D Johnston ◽  
Deanna P Jannat-Khah ◽  
Samuel C Williams ◽  
Tanya M Ellman ◽  
...  
Keyword(s):  
Clinical Characteristics ◽  
Invasive Mechanical Ventilation ◽  
Clinical Manifestations ◽  
Supplemental Oxygen ◽  
Control Group ◽  
Electronic Health Record Data ◽  
Duration Of Symptoms ◽  
Radiographic Findings ◽  
Presenting Symptoms ◽  
And Control

Abstract Background The spread of SARS-CoV-2 and the COVID-19 pandemic have caused significant morbidity and mortality worldwide. The clinical characteristics and outcomes of hospitalized patients with SARS-CoV-2 and HIV co-infection remain uncertain. Methods We conducted a matched retrospective cohort study of adults hospitalized with a COVID-19 illness in New York City between March 3, 2020, and May 15, 2020. We matched 30 people with HIV (PWH) with 90 control group patients without HIV based on age, sex, and race/ethnicity. Using electronic health record data, we compared demographic characteristics, clinical characteristics, and clinical outcomes between PWH and control patients. Results In our study, the median age (interquartile range) was 60.5 (56.6–70.0) years, 20% were female, 30% were black, 27% were white, and 24% were of Hispanic/Latino/ethnicity. There were no significant differences between PWH and control patients in presenting symptoms, duration of symptoms before hospitalization, laboratory markers, or radiographic findings on chest x-ray. More patients without HIV required a higher level of supplemental oxygen on presentation than PWH. There were no differences in the need for invasive mechanical ventilation during hospitalization, length of stay, or in-hospital mortality. Conclusions The clinical manifestations and outcomes of COVID-19 among patients with SARS-CoV-2 and HIV co-infection were not significantly different than patients without HIV co-infection. However, PWH were hospitalized with less severe hypoxemia, a finding that warrants further investigation.

Tenofovir Urine Assay to Monitor Adherence to HIV Pre-exposure Prophylaxis

2020 ◽  
Vol 15 (2) ◽  
pp. 102-104
Author(s):  
Ganesh S. Moorthy ◽  
Linden Lalley-Chareczko ◽  
Helen C. Koenig ◽  
Athena F. Zuppa
Keyword(s):  
High Performance ◽  
Retention In Care ◽  
Self Report ◽  
Resource Limited ◽  
Hepatitis B Treatment ◽  
Urine Assay ◽  
Tenofovir Alafenamide ◽  
Sex With Men ◽  
Exposure Prophylaxis

Tenofovir Disoproxil Fumarate (TDF) and tenofovir Alafenamide (TAF) are prodrugs of tenofovir and have excellent long-term efficacy and tolerability for the treatment of HIV. An objective marker of adherence to tenofovir-based therapy could be clinically useful in supporting adherence to TDF-based HIV pre-Exposure Prophylaxis (PrEP) in populations in whom, self-report has been shown to be unreliable, and could play a role in resource-limited settings to support HIV and hepatitis B treatment adherence. A semi-quantitative high-performance liquid chromatographymass spectrometry method for tenofovir quantification of urine samples was developed. This assay detects tenofovir concentration in log10 levels between 1 and 10,000 ng/mL, and was shown to distinguish between recent adherence and low/non-adherence to both TDF and TAF, with a concentration of >1000 ng/mL, highly predictive of medication ingestion in the last 24-48 hours. This assay was validated relative to other markers of adherence including dried blood spot and selfreport in a highly adherent population of PrEP patients, and tenofovir was shown to be stable at room temperature in urine for at least 14 days. The assay was successfully used in a clinical setting to maintain high PrEP adherence and retention in care of 50 young men who have sex with men (MSM) over 48 weeks, to assess PrEP adherence in youth with mental health conditions, and to monitor drug levels relative to plasma levels in a case study of chewed TDF/FTC (tenofovir/emtricitabine) for PrEP. Further studies are underway to implement the tenofovir urine assay to monitor adherence and pre-exposure prophylaxis, nationally and internationally.

scholarly journals Transmission of caprine arthritis encephalitis virus between sheep

2018 ◽  
Vol 48 (10) ◽  
Author(s):  
Carla Caroline Valença de Lima ◽  
Maria Consuêlo Caribé Ayres ◽  
Raymundo Rizaldo Pinheiro ◽  
Joselito Nunes Costa ◽  
Thiago Sampaio de Souza ◽  
...  
Keyword(s):  
Clinical Manifestations ◽  
Initial Study ◽  
Exposed Group ◽  
Encephalitis Virus ◽  
Control Group ◽  
Agar Gel ◽  
Nested Polymerase Chain Reaction ◽  
Caprine Arthritis Encephalitis Virus ◽  
Polymerase Chain ◽  
Group 2

ABSTRACT: This study was conducted to evaluate caprine arthritis encephalitis virus (CAEV) transmission among sheep using 15 lambs that were distributed in 2 experimental groups. The exposed group consisted of 10 lambs that remained with their mothers, who were experimentally infected with CAEV. The non-exposed group was characterized as the control group and was comprised of 5 lambs that remained with their CAEV-negative mothers. Blood samples were collected monthly from birth until 1 year of life. To evaluate the transmission, an agar gel immunodiffusion test (AGID), enzyme immunoassay (ELISA), immunoblotting (IB), and nested polymerase chain reaction (nPCR) techniques were used. The non-exposed group was negative in all of the tests throughout the whole experiment. In the exposed group, 2 individuals had positive nPCR results. Positive nPCR samples were sequenced for comparison with the original goat strains and were shown to be similar to the CAEV-Cork strain. Seroconversion was not detected, and clinical manifestations were not observed. Thus, after 1 year of observation, it was verified that CAEV transmission among sheep is possible; however, with discreet frequency. This was an initial study, and other experiments are needed to analyze the adaptive capacity of the CAEV to remain in an infected sheep flock and cause the disease.

scholarly journals Magnetic resonance imaging in the prone position and the diagnosis of tethered spinal cord

2018 ◽  
Vol 21 (1) ◽  
pp. 4-10 ◽  
Author(s):  
Melissa M. Stamates ◽  
David M. Frim ◽  
Carina W. Yang ◽  
Gregory L. Katzman ◽  
Saad Ali
Keyword(s):  
Spinal Cord ◽  
Sensitivity And Specificity ◽  
Clinical Manifestations ◽  
Tethered Cord ◽  
Control Group ◽  
Motion Sensitivity ◽  
Canal Width ◽  
Group 3 ◽  
Group 2 ◽  
Group 1

OBJECTIVETethered cord syndrome (TCS) is a neurosurgical disorder with varied clinical manifestations believed to result from vascular compromise due to stretch forces on the spinal cord. Conventional supine MRI findings may include a low-lying conus medullaris, thickened or fat-infiltrated filum terminale, or lipoma; however, imaging sensitivity and specificity for tethered cord can be low. The purpose of this study was to evaluate the utility of prone MRI in the diagnosis of tethered and retethered spinal cord.METHODSMedical records were reviewed in 41 patients who underwent surgical release of tethered cord and in whom preoperative prone MRI sequences were available. Patients were divided into Group 1 (new TCS diagnosis) and Group 2 (recurrent TCS after previous untethering). Absolute conus ventral motion and motion as a percentage of canal width between supine and prone positions was measured in these 2 groups via sagittal T2-weighted sequences; these groups were compared with 30 consecutive patients (Group 3) who were classified as the normal control group.RESULTSThe mean ventral motion was as follows: Group 1 (absolute: 0.5 ± 0.5 mm [range 0–2.4 mm]; canal percentage: 3.7% ± 3.9% [range 0%–16.3%]); Group 2 (absolute: 0.4 ± 0.7 mm [range 0–2.6 mm]; canal percentage: 2.2% ± 3.7% [range 0%–14.0%]); and Group 3 (absolute: 3.4 ± 1.3 mm [range 1.4–5.6 mm]; canal percentage: 22.0% ± 7.2% [range 10.5%–36.1%]). Whereas 38/41 surgically treated patients with TCS had diminished (< 10% canal width) ventral motion on preoperative MRI, 30/30 controls had > 10% canal width motion. Sensitivity and specificity were thereby calculated as 92.7% and 100%, respectively.CONCLUSIONSIn the present series, prone imaging is found to be a sensitive and specific tool, and the authors believe it may have a role as supportive evidence in the diagnosis of tethered and retethered spinal cord.

Invasive aspergillosis in adult patients with rheumatic diseases

2020 ◽  
Vol 14 (4) ◽  
pp. 16-22
Author(s):  
V. I. Mazurov ◽  
A. M. Lila ◽  
O. V. Shadrivova ◽  
M. S. Tonkoshkur ◽  
M. S. Shostak ◽  
...  
Keyword(s):  
Risk Factors ◽  
Respiratory Failure ◽  
Invasive Aspergillosis ◽  
Rheumatic Diseases ◽  
Lupus Erythematosus ◽  
Clinical Manifestations ◽  
Underlying Disease ◽  
Control Group ◽  
Group 2 ◽  
Group 1

Objective: to study risk factors for invasive aspergillosis (IA), its etiology, clinical manifestations, and treatment efficiency in patients with rheumatic diseases (RD).Patients and methods. The first study of proven and probable IA (EORT/MSGERC, 2019) was conducted in 18 patients with RD, who accounted for 3% of all adult IA patients (n=699) included in the 1998–2020 registry of the Department of Clinical Mycology, Allergology, and Immunology, I.I. Mechnikov North-Western State Medical University (Group 1). This group comprised 56% women; the median age was 59 [21; 75] years. Group 2 (a comparison group) included 610 adult hematology patients with IA (median age, 45 [18; 79] years; 42% women). A prospective case-control study was conducted to identify risk factors for IA in patients with RD: 36 rheumatic patients without IA (median age, 58 (18–79) years; 61% women) (a control group).Results and discussion. Patients with RD were found to often develop IA in the presence of anti-neutrophilic cytoplasmic antibody-associated vasculitis (granulomatosis with polyangiitis and microscopic polyangiitis) and systemic lupus erythematosus (50 and 16%, respectively). It was shown for the first time that the likelihood of IA in patients with RD increases with prolonged (median 14 days) lymphocytopenia during RD treatment (odds ratio 13.0; 95% confidence interval, 3.3–50.3). The main causative agents of IA were A. fumigatus (50%) and A. niger (29%). IA was more severe in Group 1 than in Group 2: in the resuscitation and intensive care units, there were 44 and 18%, respectively (p=0.01). Group 1 versus Group 2 more frequently had respiratory failure (61 and 37%, respectively; p=0.03), hemoptysis (28 and 7%; p=0.0001), chest pain (17 and 7%; p=0.04), and cardiac involvement (11 and 1%; p=0.0001), and less frequently had fever (67 and 85%; p=0.01). The common site of IA was the lung (83%); the characteristic feature detected by computed tomography (CT) is pulmonary cavitation (44%). Antifungal therapy was used in 89% of Group 1 patients; the overall 12-week survival was 69%.Conclusion. In patients with RD, it is difficult to differentiate between the progression of the underlying disease, adverse drug reactions, infectious complications, or a combination of these disorders due to the similarity of their clinical manifestations. When RD patients with infectious syndrome and respiratory failure develop prolonged lymphocytopenia during combination therapy, AI should be suspected and lung CT, bronchoscopy, and mycological examination of the material obtained by bronchoalveolar lavage be done.

scholarly journals Sample size calculation for active-arm trial with counterfactual incidence based on recency assay

2021 ◽  
Vol 13 (1) ◽  
Author(s):  
Fei Gao ◽  
David V. Glidden ◽  
James P. Hughes ◽  
Deborah J. Donnell
Keyword(s):  
Sample Size ◽  
Sample Size Calculation ◽  
Standard Of Care ◽  
Sub Saharan Africa ◽  
Control Group ◽  
Sample Sizes ◽  
Delivery Methods ◽  
Sub Saharan ◽  
Sex With Men ◽  
Exposure Prophylaxis

Abstract Objectives The past decade has seen tremendous progress in the development of biomedical agents that are effective as pre-exposure prophylaxis (PrEP) for HIV prevention. To expand the choice of products and delivery methods, new medications and delivery methods are under development. Future trials of non-inferiority, given the high efficacy of ARV-based PrEP products as they become current or future standard of care, would require a large number of participants and long follow-up time that may not be feasible. This motivates the construction of a counterfactual estimate that approximates incidence for a randomized concurrent control group receiving no PrEP. Methods We propose an approach that is to enroll a cohort of prospective PrEP users and aug-ment screening for HIV with laboratory markers of duration of HIV infection to indicate recent infections. We discuss the assumptions under which these data would yield an estimate of the counterfactual HIV incidence and develop sample size and power calculations for comparisons to incidence observed on an investigational PrEP agent. Results We consider two hypothetical trials for men who have sex with men (MSM) and transgender women (TGW) from different regions and young women in sub-Saharan Africa. The calculated sample sizes are reasonable and yield desirable power in simulation studies. Conclusions Future one-arm trials with counterfactual placebo incidence based on a recency assay can be conducted with reasonable total screening sample sizes and adequate power to determine treatment efficacy.

scholarly journals A Crowdsourcing Open Contest to Design Pre-Exposure Prophylaxis Promotion Messages: Protocol for an Exploratory Mixed Methods Study

10.2196/15590 ◽  
2020 ◽  
Vol 9 (1) ◽  
pp. e15590
Author(s):  
Jordan J White ◽  
Allison Mathews ◽  
Marcus P Henry ◽  
Meghan B Moran ◽  
Kathleen R Page ◽  
...  
Keyword(s):  
Mixed Methods ◽  
Community Engagement ◽  
The United States ◽  
Medical Mistrust ◽  
Community Assets ◽  
Community Needs ◽  
Group 2 ◽  
Sex With Men ◽  
Prep Awareness ◽  
Exposure Prophylaxis

Background In the United States, black men who have sex with men (BMSM) are disproportionately affected by HIV. Pre-exposure prophylaxis (PrEP) can reduce HIV incidence. However, real-world implementation of PrEP outside of clinical trials has identified racial disparities in PrEP awareness, uptake, and adherence. In the context of a long history of medical mistrust and power imbalances between scientists and community members, strategies to increase uptake of PrEP among BMSM should consider ways to ensure messages address the needs and priorities of the community. Crowdsourcing contests shift traditional individual tasks to a large group and may enhance community engagement. Objective This paper describes the research protocol of a contest approach to soliciting PrEP promotion messages among BMSM in Baltimore. Methods Open-contest implementation and evaluation will proceed as follows: (1) organize a community steering group; (2) develop platforms to solicit crowd input; (3) engage the community to contribute ideas through a Web-based forum and in-person events; (4) evaluate contest entries using both community panel judge assessment and crowd voting; (5) utilize mixed methods to evaluate feasibility, acceptability, and community engagement; and (6) disseminate contest results. Results This study was funded by the National Institutes of Health (National Institute of Mental Health: R34MH116725) in May 2018 and was approved by the institutional review board in April 2018. The open contest started in February 2019, and data analyses for the mixed method evaluation are expected to complete in December 2019. Conclusions The contest will potentially bring new ideas in developing more impactful and locally defined PrEP promotion campaigns. We will determine whether an open-contest approach is acceptable among BMSM in Baltimore. If successful, this study can inform future projects using a similar approach on how to identify and implement programs and policies that are more responsive to community needs and that build up community assets. International Registered Report Identifier (IRRID) DERR1-10.2196/15590

scholarly journals Seroprevalence of anti-SARS-CoV-2 antibodies in Japanese COVID-19 patients

PLoS ONE ◽  
2021 ◽  
Vol 16 (4) ◽  
pp. e0249449
Author(s):  
Makoto Hiki ◽  
Yoko Tabe ◽  
Tomohiko Ai ◽  
Yuya Matsue ◽  
Norihiro Harada ◽  
...  
Keyword(s):  
Severe Acute Respiratory Syndrome ◽  
Symptom Onset ◽  
Detection Rate ◽  
Clinical Manifestations ◽  
Rapid Test ◽  
Igg Antibodies ◽  
Antibody Assay ◽  
Serum Samples ◽  
Igg Antibody ◽  
Chemiluminescent Microparticle Immunoassay

Objectives To determine the seroprevalence of anti-SARS-CoV-2 IgG and IgM antibodies in symptomatic Japanese COVID-19 patients. Methods Serum samples (n = 114) from 34 COVID-19 patients with mild to critical clinical manifestations were examined. The presence and titers of IgG antibody for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) were determined by a chemiluminescent microparticle immunoassay (CMIA) using Alinity i SARS-CoV-2 IgG and by an immunochromatographic (IC) IgM/IgG antibody assay using the Anti-SARS-CoV-2 Rapid Test. Results IgG was detected by the CMIA in 40%, 88%, and 100% of samples collected within 1 week, 1–2 weeks, and 2 weeks after symptom onset in severe and critical cases, and 0%, 38%, and 100% in mild/moderate cases, respectively. In severe and critical cases, the positive IgG detection rate with the IC assay was 60% within one week and 63% between one and two weeks. In mild/moderate cases, the positive IgG rate was 17% within one week and 63% between one and two weeks; IgM was positive in 80% and 75% of severe and critical cases, and 42% and 88% of mild/moderate cases, respectively. On the CMIA, no anti-SARS-CoV-2 IgG antibodies were detected in COVID-19 outpatients with mild symptoms within 10 days from onset, whereas 50% of samples from severe inpatients were IgG-positive in the same period. The IC assay detected higher IgM positivity earlier from symptom onset in severe and critical cases than in mild/moderate cases. Conclusions A serologic anti-SARS-CoV-2 antibody analysis can complement PCR for diagnosing COVID-19 14 days after symptom onset.

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