Clinical evaluation of rapid point-of-care antigen tests for diagnosis of SARS-CoV-2 infection

AbstractThe RT-qPCR in respiratory specimens is the gold standard for diagnosing acute COVID-19 infections. However, this test takes considerable time before test results become available, thereby delaying patients from being diagnosed, treated, and isolated immediately. Rapid antigen tests could overcome this problem. In the first study, clinical performances of five rapid antigen tests were compared to RT-qPCR in upper respiratory specimens from 40 patients with positive and 40 with negative RTq-PCR results. In the second study, the rapid antigen test with one of the best test characteristics (Romed) was evaluated in a large prospective collection of upper respiratory specimens from 900 different COVID-19-suspected patients (300 emergency room patients, 300 nursing home patients, and 300 health care workers). Test specificities ranged from 87.5 to 100.0%, and test sensitivities from 55.0 to 80.0%. The clinical specificity of the Romed test was 99.8% (95% CI 98.9–100). Overall clinical sensitivity in the study population was 73.3% (95% CI 67.9–78.2), whereas sensitivity in the different patient groups varied from 65.3 to 86.7%. Sensitivity was 83.0 to 86.7% in patients with short duration of symptoms. In a population with a COVID-19 prevalence of 1%, the negative predictive value in all patients was 99.7%. There is a large variability in diagnostic performance between rapid antigen tests. The Romed rapid antigen test showed a good clinical performance in patients with high viral loads (RT-qPCR cycle threshold ≤30), which makes this antigen test suitable for rapid identification of COVID-19-infected health care workers and patients.

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Clinical evaluation of rapid point of care antigen tests for diagnosis of SARS-CoV-2 infection

10.21203/rs.3.rs-176725/v1 ◽

2021 ◽

Author(s):

Johannes G.M. Koeleman ◽

Henk Brand ◽

Stijn J. de Man ◽

David Ong

Keyword(s):

Clinical Performance ◽

Point Of Care ◽

Rapid Identification ◽

Antigen Test ◽

Large Variability ◽

Clinical Sensitivity ◽

Nursing Home Patients ◽

Upper Respiratory ◽

Antigen Tests ◽

Respiratory Specimens

Abstract Purpose: The RT-qPCR in respiratory specimens is the gold standard for diagnosing acute COVID-19 infections. However, this test takes considerable time before test results become available, thereby delaying diagnosed COVID-19 patients to be treated and isolated immediately. Rapid antigen tests could overcome this problem and therefore a large number of COVID-19 rapid antigen tests have been developed. Methods: In this study clinical performances of five rapid antigen tests were compared to RT-qPCR in upper respiratory specimens from 80 patients. In addition, the rapid antigen test with the best test characteristics (Romed) was evaluated in a large prospective collection of randomly selected upper respiratory specimens from 900 different COVID-19 suspected patients (300 emergency room patients, 300 nursing home patients and 300 health care workers) in the period from October 24 to November 15, 2020. Results: Overall specificity was almost 100% and sensitivity ranged from 55.0% to 80.0%. The clinical specificity of the Romed test was 99.8% (95% CI 98.9-100). Overall clinical sensitivity in the study population was 73.3% (95% CI 67.9-78.2), whereas sensitivity in the different groups varied from 65.3% to 86.7%. Sensitivity was highest in patients with short-term symptoms. In a population with a COVID-19 prevalence of 1% the negative predictive value in all patients was 99.7%. Conclusion: There is a large variability in diagnostic performance between rapid antigen tests. The Romed rapid antigen test showed a good clinical performance in patients with high viral loads, which makes this antigen test suitable for rapid identification of COVID-19 infected patients.

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Evaluation of the Panbio™ rapid antigen test for COVID-19 diagnosis in symptomatic health care workers.

10.1101/2021.06.21.21259234 ◽

2021 ◽

Author(s):

Marjan J. Bruins ◽

Claudy Oliveira dos Santos ◽

Marjan Spoelman-Lunsche ◽

Marieke I. van den Bos-Kromhout ◽

Sylvia B. Debast

Keyword(s):

Health Care ◽

Health Care Workers ◽

False Negative ◽

Rapid Test ◽

High Sensitivity ◽

High Tech ◽

Antigen Test ◽

Duration Of Symptoms ◽

Recent Onset ◽

Care Workers

If a health care workers (HCW) experiences COVID-19 associated symptoms, SARS-CoV-2 testing must be performed as soon as possible, to prevent transmission of the virus and to guarantee continuity of care. The gold standard for the detection of SARS-CoV-2, RT-PCR, has a high sensitivity but usually takes 6-8 hours. Lateral flow antigen assays take only 15-30 minutes and do not need any high tech equipment. In a prospective study of our hospital's HCWs, we evaluated the sensitivity of the Panbio™ COVID-19 Ag Rapid Test (Abbott) against the molecular test Aptima™ SARS-CoV-2 Assay (Hologic) which uses Transcription Mediated Amplification (TMA). TMA positive samples were further subjected to a quantitative real-time SARS-CoV-2 PCR to obtain Ct values as an indication of the viral load. Of 1101 HCWs included in the study between November 2020 and February 2021, 84 (7.6%) were TMA positive, of which 48 (57.1%) were antigen test positive. Most false negative antigen test results occurred if the duration of symptoms had been ≤1 day or ≥7 days. Sensitivities for symptom onset of ≤1, 2 or 3 days were 47.1%, 63.0% and 66.7% respectively. The Panbio™ rapid test is fast and easy to perform, but is not a suitable SARS-CoV-2 test to confirm or exclude COVID-19 in HCWs with a very recent onset of symptoms.

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Occupational Allergic Diseases in Kitchen and Health Care Workers: An Underestimated Health Issue

BioMed Research International ◽

10.1155/2013/285420 ◽

2013 ◽

Vol 2013 ◽

pp. 1-4 ◽

Cited By ~ 8

Author(s):

Ugur Bilge ◽

Ilhami Unluoglu ◽

Nazan Son ◽

Ahmet Keskin ◽

Yasemin Korkut ◽

...

Keyword(s):

Health Care ◽

General Population ◽

Health Care Workers ◽

Health Issue ◽

Upper Respiratory Tract ◽

Care Providers ◽

The Past ◽

Care Workers ◽

Upper Respiratory ◽

Tract Infections

Objective. This study evaluated the frequencies of allergic symptoms and rate of upper respiratory infections during the past year in the general population, kitchen workers (KW) and health care workers (HCW).Methods. The European Community Respiratory Health Survey (ECRHS) was used to inquire retrospectively about asthma and asthma-like symptoms and the number of treatments required for previous upper respiratory tract infections (URTI: acute pharyngitis, acute sinusitis, etc.) during the past year for health care workers, kitchen workers, and members of the general population. Adjusted odds ratios by gender, age, and smoking status were calculated.Results. 579 subjects (186 from the general population, 205 KW, and 188 HCW; 263 females, 316 males) participated in the study. Noninfectious (allergic) rhinitis was significantly higher in the HCW and KW groups than in the general population (P<0.001). Cumulative asthma was significantly higher only in the HCW group (P<0.05). In addition, the HCW and KW groups had significantly higher risks of ≥2/year URTI (OR: 1.59, 95% CI: 1.07–2.38 versus OR: 1.57, 95% CI: 1.05–2.38) than the general population.Conclusion. Occupational allergic respiratory diseases are an important and growing health issue. Health care providers should become familiar with workplace environments and environmental causes of occupational rhinitis and asthma.

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Evaluation of SARS-CoV-2 Existence in Blood, Urine, and Rectal Swab in Positive Patients with Different Virus Titers

Jundishapur Journal of Microbiology ◽

10.5812/jjm.106534 ◽

2020 ◽

Vol 13 (8) ◽

Author(s):

Mahdieh Mondanizadeh ◽

Ensiye Hrahimi ◽

Hossein Sarmadian ◽

Mohammad Jamalian ◽

Behzad Khansarinejad

Keyword(s):

Health Care Workers ◽

Rectal Swab ◽

Rna Extraction ◽

Pcr Assay ◽

Virus Shedding ◽

Care Workers ◽

Upper Respiratory ◽

Positive Results ◽

Urine Specimens ◽

Respiratory Specimens

Background: Coronavirus disease 2019 (COVID-19) is an infectious disease caused by a newly discovered coronavirus. Understanding the spreading routes of SARS-CoV-2 is crucial for patient management and defining biosafety strategies for public and health care workers. Objectives: In the current study, the virus shedding in the upper respiratory as well as blood, stool, and urine specimens of infected patients, was examined using quantitative real-time PCR assay (qRT-PCR). Methods: The samples of 50 positive patients with high, moderate, and low virus titers in their respiratory specimens were collected. All specimens were subjected to RNA extraction and RT-qPCR assay using two different internally-controlled test systems. Results: The results indicated that no positive results were observed in the urine samples of all patients. The viral genome was diagnosed in 5% of blood and 3.3% of rectal swab samples. The Cq (Cycle of quantification)-values of positive results on the stool and blood samples were always higher than the Cq-value of the respiratory specimen of the same patient. Conclusions: SARS-CoV-2 is mainly detected in the respiratory samples, and the virus is not detectable in the urine. The importance of viremia and the existence of the virus in feces in virus spread in the human population needs further investigation.

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Evaluation of SARS-CoV-2 existence in blood, urine, and rectal swab in positive patients with different virus titers

10.21203/rs.3.rs-20499/v1 ◽

2020 ◽

Cited By ~ 1

Author(s):

Mahdieh Mondanizadeh ◽

Ensiyeh Rahimi ◽

Hossein Sarmadian ◽

Mohammad Jamalian ◽

Behzad Khansarinejad

Keyword(s):

Health Care ◽

Health Care Workers ◽

Real Time Pcr ◽

Patient Management ◽

Rectal Swab ◽

Pcr Assay ◽

Virus Shedding ◽

Care Workers ◽

Upper Respiratory ◽

Urine Specimens

Abstract Understanding the spreading routes of SARS-CoV-2 is crucial for patient management and defining biosafety strategies for public and health care workers. In the current study, the virus shedding in upper respiratory as well as blood, stool, and urine specimens of infected patients was examined using reverse transcription real-time PCR assay (RT-qPCR).

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Viral and bacterial upper respiratory tract infection in hospital health care workers over time and association with symptoms

BMC Infectious Diseases ◽

10.1186/s12879-017-2649-5 ◽

2017 ◽

Vol 17 (1) ◽

Cited By ~ 4

Author(s):

C. Raina MacIntyre ◽

Abrar Ahmad Chughtai ◽

Yi Zhang ◽

Holly Seale ◽

Peng Yang ◽

...

Keyword(s):

Health Care ◽

Tract Infection ◽

Respiratory Tract ◽

Respiratory Tract Infection ◽

Health Care Workers ◽

Upper Respiratory Tract Infection ◽

Upper Respiratory Tract ◽

Care Workers ◽

Upper Respiratory ◽

Over Time

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P156 Metagenomic analysis of upper respiratory tract microbiome in Korean health-care workers, community people and pneumonia patients

International Journal of Antimicrobial Agents ◽

10.1016/s0924-8579(13)70399-6 ◽

2013 ◽

Vol 42 ◽

pp. S91

Author(s):

H. Yi ◽

J. Chun ◽

D. Yong ◽

K. Lee

Keyword(s):

Health Care ◽

Respiratory Tract ◽

Health Care Workers ◽

Metagenomic Analysis ◽

Upper Respiratory Tract ◽

Care Workers ◽

Community People ◽

Upper Respiratory

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Sero-monitoring of health care workers reveals complex relationships between common coronavirus antibodies and SARS-CoV-2 severity

10.1101/2021.04.12.21255324 ◽

2021 ◽

Author(s):

Sigrid Gouma ◽

Madison E. Weirick ◽

Marcus J. Bolton ◽

Claudia P. Arevalo ◽

Eileen C. Goodwin ◽

...

Keyword(s):

Health Care ◽

Health Care Workers ◽

Duration Of Symptoms ◽

Cellular Immune Responses ◽

Care Workers ◽

Immunological Mechanisms ◽

Antibody Titers ◽

Complex Relationships ◽

Cellular Immune ◽

Reduce Disease Severity

Recent common coronavirus (CCV) infections are associated with reduced COVID-19 severity upon SARS-CoV-2 infection, however the immunological mechanisms involved are unknown. We completed serological assays using samples collected from health care workers to identify antibody types associated with SARS-CoV-2 protection and COVID-19 severity. Rare SARS-CoV-2 cross-reactive antibodies elicited by past CCV infections were not associated with protection; however, the duration of symptoms following SARS-CoV-2 infections was significantly reduced in individuals with higher common betacoronavirus (betaCoV) antibody titers. Since antibody titers decline over time after CCV infections, individuals in our cohort with higher betaCoV antibody titers were more likely recently infected with common betaCoVs compared to individuals with lower antibody titers. Therefore, our data suggest that recent betaCoV infections potentially limit the severity of SARS-CoV-2 infections through mechanisms that do not involve cross-reactive antibodies. Our data are consistent with the emerging hypothesis that cellular immune responses elicited by recent common betaCoV infections transiently reduce disease severity following SARS-CoV-2 infections.

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