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1.
Crit Rev Clin Lab Sci ; : 1-15, 2022 Mar 15.
Article in English | MEDLINE | ID: covidwho-1740611

ABSTRACT

A plethora of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) diagnostic tests are available, each with different performance specifications, detection methods, and targets. This narrative review aims to summarize the diagnostic technologies available and how they are best selected to tackle SARS-CoV-2 infection as the pandemic evolves. Seven key settings have been identified where diagnostic tests are being deployed: symptomatic individuals presenting for diagnostic testing and/or treatment of COVID-19 symptoms; asymptomatic individuals accessing healthcare for planned non-COVID-19-related reasons; patients needing to access emergency care (symptom status unknown); patients being discharged from healthcare following hospitalization for COVID-19; healthy individuals in both single event settings (e.g. airports, restaurants, hotels, concerts, and sporting events) and repeat access settings (e.g. workplaces, schools, and universities); and vaccinated individuals. While molecular diagnostics remain central to SARS-CoV-2 testing strategies, we have offered some discussion on the considerations for when other tools and technologies may be useful, when centralized/point-of-care testing is appropriate, and how the various additional diagnostics can be deployed in differently resourced settings. As the pandemic evolves, molecular testing remains important for definitive diagnosis, but increasingly widespread point-of-care testing is essential to the re-opening of society.

2.
EuropePMC; 2022.
Preprint in English | EuropePMC | ID: ppcovidwho-329578

ABSTRACT

Saliva sample can be self-collected and used in testing of SARS-CoV-2 nucleic acid amplification tests (NAATs) test in Japan. However, this may have difficulty collecting a proper specimen when collecting for the first time. We compared 2 collection methods, conventional methods and Direct Saliva Sample Collection method (DiSC) from 44 asymptomatic or symptomatic individuals who were in quarantine in Toho university hospital. RT-PCR by DiSC method showed about 70 % positive percent agreement compared to RT-PCR by conventional methods. In addition, comparing RT-PCR and TMA by DiSC method, TMA showed about 90 % positive percent agreement compared to RT-PCR. DiSC method is easy to perform by every person, does not have complicated restrictions/instructions and can be used in RT-PCR and TMA. This method allows for ease of saliva collection in certain patient populations.

3.
Diagn Microbiol Infect Dis ; 102(4): 115640, 2022 Apr.
Article in English | MEDLINE | ID: covidwho-1654299

ABSTRACT

The objective of this retrospective study was to identify the clinical risk factor associated with uric acid elevation in coronavirus disease (COVID-19) patients treated with favipiravir. Uric acid elevation was defined as an unexplained increase of ≥1.5 times in the patient's uric acid level from baseline. Twenty-nine COVID-19 patients were included in the study. Uric acid elevation developed during favipiravir therapy in 12 (41.4%) patients and the median onset time was 4.5 days after starting favipiravir. In multiple logistic regression analysis, the favipiravir dosage (adjusted OR = 1.69 [1.02-2.81], P = 0.044) and younger patient age (adjusted OR = 0.91 [0.83-0.99], P = 0.040) were significant clinical risk factors for uric acid elevation. No significant between-group difference was noted in the uric acid elevation and non-elevation groups in the clinical recovery after favipiravir therapy. The uric acid levels of patients administered with favipiravir should be monitored closely.


Subject(s)
COVID-19 , Uric Acid , Amides , Antiviral Agents/adverse effects , COVID-19/drug therapy , Humans , Pyrazines , Retrospective Studies , Risk Factors , SARS-CoV-2 , Treatment Outcome
4.
J Nippon Med Sch ; 88(4): 380-383, 2021 Sep 01.
Article in English | MEDLINE | ID: covidwho-1551292

ABSTRACT

We assessed the association of severity of coronavirus disease 2019 (COVID-19) with acute respiratory syndrome coronavirus 2 (SARS-CoV-2) load, IgG antibody level, and prognostic indicators.Twenty-one patients hospitalized with COVID-19 were classified as having severe or mild disease on the basis of average respiratory rate during hospitalization (severe: ≥22 breaths/min; mild: <22 breaths/min). Viral load in nasopharyngeal samples, blood levels of C-reactive protein (CRP), lymphocytes, and D-dimer on admission and plasma immunoglobulin G (IgG) index on Day 7±2 after symptom onset were compared in relation to disease severity. Seven patients had severe disease and 14 had mild disease. Those with severe disease had a significantly higher IgG index (median: 3.75 vs 0.56, p=0.01) and CRP (median: 8.6 vs 1.0 mg/dL, p<0.001) and D-dimer levels (median: 1.65 vs 0.75 µg/mL; p=0.002) and a significantly lower lymphocyte count (median: 1,176 vs 666 cells/µL, p=0.005) and viral load (median: 8.7×106 vs 2.3×104 copies/mL, p=0.005). Furthermore, time from symptom onset to virus disappearance was significantly longer in severe patients (median: 24 vs 17 days, p=0.03). A high IgG index in the early phase of the disease was associated with severe disease and might serve as a prognostic indicator.


Subject(s)
Antibodies, Viral/blood , COVID-19 Nucleic Acid Testing , COVID-19 Serological Testing , COVID-19/diagnosis , Immunoglobulin G/blood , SARS-CoV-2/pathogenicity , Viral Load , Adult , Aged , Biomarkers/blood , COVID-19/blood , COVID-19/drug therapy , COVID-19/therapy , COVID-19/virology , Female , Hospitalization , Host-Pathogen Interactions , Humans , Japan , Male , Middle Aged , Oxygen Inhalation Therapy , Predictive Value of Tests , Prognosis , SARS-CoV-2/genetics , SARS-CoV-2/immunology , Severity of Illness Index , Time Factors
5.
Emerg Infect Dis ; 27(10): 1-9, 2021 10.
Article in English | MEDLINE | ID: covidwho-1486730

ABSTRACT

To deal with the risk of emerging diseases with many unknowns, close and timely collaboration and communication between science experts and policymakers are crucial to developing and implementing an effective science-based intervention strategy. The Expert Meeting, an ad hoc medical advisory body, was established in February 2020 to advise Japan's COVID-19 Response Headquarters. The group played an important role in the policymaking process, promoting timely situation awareness and developing science-based proposals on interventions that were promptly reflected in government actions. However, this expert group may have been overly proactive in taking on the government's role in crisis management. For the next stage of managing the coronavirus disease pandemic and future pandemics, the respective roles of the government and its advisory bodies need to be clearly defined. Leadership and strategic risk communication by the government are key.


Subject(s)
COVID-19 , Government , Humans , Japan/epidemiology , Pandemics , SARS-CoV-2
6.
Nihon Naika Gakkai Zasshi ; 109(9):2028-2029, 2020.
Article in English | J-STAGE | ID: covidwho-1406027
7.
Ann Lab Med ; 41(6): 568-576, 2021 Nov 01.
Article in English | MEDLINE | ID: covidwho-1264320

ABSTRACT

BACKGROUND: Coronavirus disease 2019 (COVID-19), caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), is generally diagnosed by reverse transcription (RT)-PCR or serological assays. The SARS-CoV-2 viral load decreases a few days after symptom onset. Thus, the RT-PCR sensitivity peaks at three days after symptom onset (approximately 80%). We evaluated the performance of the ARCHITECT® SARS-CoV-2 IgG assay (henceforth termed IgG assay; Abbott Laboratories, Lake County, IL, USA), and the combination of RT-PCR and the IgG assay for COVID-19 diagnosis. METHODS: In this retrospective study, 206 samples from 70 COVID-19 cases at two hospitals in Tokyo that were positive using RT-PCR were used to analyze the diagnostic sensitivity. RT-PCR-negative (N=166), COVID-19-unrelated (N=418), and Japanese Red Cross Society (N=100) samples were used to evaluate specificity. RESULTS: Sensitivity increased daily after symptom onset and exceeded 84.4% after 10 days. Specificity ranged from 98.2% to 100% for samples from the three case groups. Seroconversion was confirmed from 9 to 20 days after symptom onset in 18 out of 32 COVID-19 cases with multiple samples and from another case with a positive result in the IgG assay for the first available sample. CONCLUSIONS: The combination of RT-PCR and IgG assay improves the robustness of laboratory diagnostics by compensating for the limitations of each method.


Subject(s)
COVID-19/diagnosis , Immunoglobulin G/analysis , RNA, Viral/analysis , Antibodies, Viral/analysis , COVID-19/virology , COVID-19 Testing , Humans , Longitudinal Studies , RNA, Viral/metabolism , Reagent Kits, Diagnostic , Retrospective Studies , Reverse Transcriptase Polymerase Chain Reaction , SARS-CoV-2/genetics , SARS-CoV-2/immunology , SARS-CoV-2/isolation & purification , Sensitivity and Specificity
8.
Gen Thorac Cardiovasc Surg ; 69(7): 1159-1162, 2021 Jul.
Article in English | MEDLINE | ID: covidwho-1163151

ABSTRACT

A 65-year-old man with coronavirus disease 2019 (COVID-19) was admitted to our hospital. Computed tomography detected bilateral pneumonia with a lung nodule suspicious for lung cancer. Lobectomy was performed 3 months after the treatment for COVID-19 without any complications. The surgical specimen revealed fibrosis below the pleura with a small collection of lymphocytes and intravascular hemorrhagic thrombosis, and no residual RNA was detected. This is the first report describing a surgical specimen after recovery from COVID-19 pneumonia, and suggests that elective thoracic surgery can be performed safely, depending on the patient's respiratory function, without infectious risk.


Subject(s)
COVID-19 , Pneumonia , Aged , Elective Surgical Procedures , Humans , Lung/diagnostic imaging , Lung/surgery , Male , SARS-CoV-2
9.
Jpn J Infect Dis ; 74(6): 560-562, 2021 Nov 22.
Article in English | MEDLINE | ID: covidwho-1110732

ABSTRACT

Most coronavirus disease 2019 (COVID-19) cases are mild or asymptomatic, and a substantial minority of patients have severe or critical diseases. There are several reports on the potential risk factors of severe disease, but few reports have reported a relationship between antibody titer and severity in Japan. Antibody-dependent enhancement affects disease progression. We evaluated the IgG responses in COVID-19 patients at our tertiary hospital. The IgG index was the measure of interest. We assigned 1.4 as the cutoff value for a positive result based on the specifications by the manufacturer and observed that patients could be categorized into two groups: the early elevation of IgG and late elevation of IgG (IgG elevated in the first 7 days ± 2 days or more than 10 days after symptom onset) groups. The former comprised early IgG responders (n = 7) and the latter comprised late IgG responders (n = 14), and they were compared. The C-reactive protein and D-dimer concentrations were significantly higher in the early IgG responders on admission (HD 0). The respiratory rate was also higher. The lymphocytes were significantly fewer on day 7 of hospitalization (HD 7). These results suggest that early production of anti-severe acute respiratory syndrome coronavirus 2 IgG may be associated with clinical indicators of severity.


Subject(s)
Antibodies, Viral/immunology , COVID-19 , Immunoglobulin G/immunology , COVID-19/immunology , COVID-19/pathology , Humans , Japan , Severity of Illness Index
10.
J Infect Chemother ; 27(6): 915-918, 2021 Jun.
Article in English | MEDLINE | ID: covidwho-1101365

ABSTRACT

INTRODUCTION: The rapid and accurate detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is required to prevent the spread of COVID-19. This study evaluated the utility of two SARS-CoV-2 antigen detection methods. METHODS: We evaluated two types of antigen detection methods using immunochromatography (Espline) and quantitative chemiluminescent enzyme immunoassay (Lumipulse). RT-PCR was performed as a standard procedure for COVID-19 diagnosis. Lumipulse and RT-PCR were performed for all 486 nasopharyngeal swabs and 136 saliva samples, and the Espline test was performed for 271 nasopharyngeal swabs and 93 saliva samples. RESULTS: The sensitivity and specificity of the Espline test were 10/11 and 260/260 (100%), respectively for the nasopharyngeal swabs and 3/9 and 84/84 (100%), respectively for the saliva samples. High sensitivities for both saliva (8/9) and nasopharyngeal swabs (22/24) were observed in the Lumipulse test. The specificities of the Lumipulse test for nasopharyngeal swabs and saliva samples were 460/462 (99.6%) and 123/127 (96.9%), respectively. CONCLUSION: The Espline test is not effective for saliva samples but is useful for simple and rapid COVID-19 tests using nasopharyngeal swabs because it does not require special devices. The Lumipulse test is a powerful high-throughput tool for COVID-19 diagnosis because it has high detection performance for nasopharyngeal swabs and saliva samples.


Subject(s)
COVID-19 Testing/methods , COVID-19/diagnosis , Chromatography, Affinity , Immunoenzyme Techniques , Luminescent Measurements , Adolescent , Adult , Aged , Aged, 80 and over , Antigens, Viral/isolation & purification , Child , Female , Humans , Male , Middle Aged , Nasopharynx/virology , Saliva/virology , Young Adult
11.
J Infect Chemother ; 27(2): 384-386, 2021 Feb.
Article in English | MEDLINE | ID: covidwho-988374

ABSTRACT

We evaluated the rapid immunochromatographic test for severe acute respiratory coronavirus 2 (SARS-CoV-2) antigen detection using 16 saliva specimens collected from 6 COVID-19 hospitalized patients, and detected N-antigen in 4 of 7 RT-PCR positive specimens. This POCT detected SARS-CoV-2 antigen in saliva and would be useful for COVID-19 diagnosis.


Subject(s)
Antigens, Viral/analysis , COVID-19 Serological Testing/methods , COVID-19/diagnosis , SARS-CoV-2/immunology , Saliva/virology , Humans , Immunologic Tests , Nasopharynx/virology , Point-of-Care Testing , RNA, Viral/analysis , Reverse Transcriptase Polymerase Chain Reaction/methods , SARS-CoV-2/isolation & purification , Sensitivity and Specificity
12.
J Infect Chemother ; 27(2): 319-322, 2021 Feb.
Article in English | MEDLINE | ID: covidwho-988373

ABSTRACT

BACKGROUND: To prevent the novel coronavirus disease 2019 (COVID-19) pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), it is necessary to perform early identification and isolation of people shedding the infectious virus in biological materials with high viral loads several days prior to symptom onset. Rapid antigen tests for infectious diseases are useful to prevent the pandemic spread in clinical settings. METHODS: We evaluated a SARS-CoV-2 antigen test, Espline® SARS-CoV-2 reagent, with reverse transcription polymerase chain reaction (RT-PCR) as reference test, using 129 nasopharyngeal swab specimens collected from COVID-19 hospitalized patients or from patients suspected having COVID-19-like symptoms. Out of these, 63 RT-PCR positive and 66 RT-PCR negative specimens were identified. RESULTS: Among 63 RT-PCR positive specimens, 25 were positive in the Espline test. Test sensitivity was estimated based on the 532.4 copies/reaction of SARS-CoV-2 RNA obtained through receiver operating characteristic analysis. When the specimens were classified based on time since symptom onset, Espline test sensitivity were 73.3% and 29.2% in specimens collected before day 9 and after day 10, respectively. CONCLUSION: Although the overall sensitivity of the Espline® SARS-CoV-2 reagent compared with RT-PCR is less, this antigen test can be useful in identifying people with high risk of virus transmission with high viral loads in order to prevent the pandemic and is useful for diagnosing COVID-19 within 30 min.


Subject(s)
Antigens, Viral/analysis , COVID-19 Serological Testing/methods , COVID-19/diagnosis , SARS-CoV-2/immunology , COVID-19/virology , Humans , Indicators and Reagents , Nasopharynx/virology , Pandemics , RNA, Viral , ROC Curve , Reverse Transcriptase Polymerase Chain Reaction/methods , SARS-CoV-2/isolation & purification , Sensitivity and Specificity , Viral Load
13.
J Infect Chemother ; 27(4): 613-616, 2021 Apr.
Article in English | MEDLINE | ID: covidwho-956008

ABSTRACT

BACKGROUND: Expansion of the testing capacity for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is an important issue to mitigate the pandemic of coronavirus disease-2019 (COVID-19) caused by this virus. Recently, a sensitive quantitative antigen test (SQT), Lumipulse® SARS-CoV-2 Ag, was developed. It is a fully automated chemiluminescent enzyme immunoassay system for SARS-CoV-2. METHODS: In this study, the analytical performance of SQT was examined using clinical specimens from nasopharyngeal swabs using reverse transcription polymerase chain reaction (RT-PCR) as a control. RESULTS: Receiver operating characteristic analysis of 24 SARS-CoV-2-positive and 524 -negative patients showed an area under the curve of 0.957 ± 0.063. Using a cut-off value of 1.34 pg/ml, the sensitivity was 91.7%, the specificity was 98.5%, and the overall rate of agreement was 98.2%. In the distribution of negative cases, the 99.5 percentile value was 1.03 pg/ml. There was a high correlation between the viral load calculated using the cycle threshold value of RT-PCR and the concentration of antigen. The tendency for the antigen concentration to decrease with time after disease onset correlated with that of the viral load. CONCLUSIONS: Presented results indicate that SQT is highly concordant with RT-PCR and should be useful for the diagnosis of COVID-19 in any clinical setting. Therefore, this fully automated kit will contribute to the expansion of the testing capability for SARS-CoV-2.


Subject(s)
Antigens, Viral/analysis , COVID-19/diagnosis , Nasopharynx/virology , SARS-CoV-2/immunology , Viral Load , COVID-19/virology , Humans , Reverse Transcriptase Polymerase Chain Reaction
14.
Sci Rep ; 10(1): 20935, 2020 12 01.
Article in English | MEDLINE | ID: covidwho-953283

ABSTRACT

The World Health Organization (WHO) has published guidance recommending systemic corticosteroids for the treatment of patients with severe or critical COVID-19 and no corticosteroids for those with nonsevere COVID-19. Although their recommendations for critical cases were based on the results from seven randomized controlled trials (RCTs), those for noncritical cases were based on the results from only one RCT, the Randomized Evaluation of COVID-19 Therapy (RECOVERY) trial. In search of additional evidence of corticosteroids' effect on COVID-19, we systematically reviewed controlled observational studies, besides RCTs, that assessed the impact of corticosteroid treatment on any type of mortality and/or other outcomes in noncritical patients. Of the 4037 titles and abstracts screened, we ultimately included the RECOVERY trial and five controlled observational studies using propensity score matching, (accessed on September 8, 2020). Two of the controlled observational studies assessed the association between corticosteroid treatment and in-hospital mortality, without finding statistical significance. Four of the controlled observational studies assessed corticosteroids' effect on other outcomes, demonstrating that they were associated with reduced risk of intubation in patients requiring oxygen and with longer hospitalization and viral shedding in mild or moderate cases. These results support the WHO recommendations not to use corticosteroids for nonsevere COVID-19.


Subject(s)
Adrenal Cortex Hormones/adverse effects , Adrenal Cortex Hormones/therapeutic use , COVID-19/drug therapy , SARS-CoV-2/drug effects , COVID-19/mortality , Humans , Observational Studies as Topic , Propensity Score , Treatment Outcome
15.
The Journal of the Japanese Society of Internal Medicine ; 109(11):2311-2315, 2020.
Article in Japanese | WHO COVID | ID: covidwho-946808

ABSTRACT

Genetic testing is undoubtedly the most important factor in the diagnosis of coronavirus disease 2019 (COVID-19), but recently, a simple and highly sensitive antigen test has been developed and made available. In addition to nasopharyngeal wipes, saliva and nasal cavity (nasal entrance) specimens have also been approved. Rapid and accurate diagnosis is essential in controlling infectious diseases, and COVID-19 is required to establish a system for rapid implementation of appropriate testing.

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