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J Clin Virol ; 133: 104684, 2020 12.
Article in English | MEDLINE | ID: covidwho-1014610


BACKGROUND: Numerous rapid antigen detection (RAD) kits for diagnosing COVID-19 patients are available in the market recently. OBJECTIVE: To compare analytical sensitivity and clinical sensitivity for the three commercially available RAD kits. STUDY DESIGN: Analytical sensitivity for the detection of SARS-CoV-2 virus was determined by limit of detection (LOD) using RT-PCR as a reference method. Clinical sensitivity was evaluated by using respiratory specimens collected from confirmed COVID-19 patients. RESULTS: The LOD results showed that the three RAD kits varied from 102-105 fold less sensitive than RT-PCR. Clinical sensitivity of RAD kits ranged from 22.9 %-71.4 % for detecting specimens from COVID-19 patients. CONCLUSIONS: Although RAD kits were less sensitive than RT-PCR, understanding the clinical characteristics of different RAD kits can guide us to obtain suitable specimens for testing. The likelihood of positive results for RAD kits will be higher.

Antigens, Viral/analysis , COVID-19 Serological Testing/methods , COVID-19/diagnosis , Nasopharynx/virology , COVID-19 Nucleic Acid Testing , Humans , Limit of Detection , Reagent Kits, Diagnostic , SARS-CoV-2/isolation & purification , Sensitivity and Specificity , Time Factors
Saf Health Work ; 11(3): 372-377, 2020 Sep.
Article in English | MEDLINE | ID: covidwho-648520


Infection risks of handling specimens associated with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by public health laboratory services teams were assessed to scrutinize the potential hazards arising from the work procedures. Through risk assessments of all work sequences, laboratory equipment, and workplace environments, no aerosol-generating procedures could be identified except the procedures (mixing and transfer steps) inside biological safety cabinets. Appropriate personal protective equipment (PPE) such as surgical masks, protective gowns, face shields/safety goggles, and disposable gloves, together with pertinent safety training, was provided for laboratory work. Proper disinfection and good hand hygiene practices could minimize the probability of SARS-CoV-2 infection at work. All residual risk levels of the potential hazards identified were within the acceptable level. Contamination by gloved hands was considered as a major exposure route for SARS-CoV-2 when compared with eye protection equipment. Competence in proper donning and doffing of PPE accompanied by hand washing techniques was of utmost importance for infection control.

J Clin Virol ; 129: 104500, 2020 08.
Article in English | MEDLINE | ID: covidwho-574549


BACKGROUND: The rapid diagnosis of Coronavirus Disease 2019 (COVID-19) patients is essential to reduce the disease spread. Rapid antigen detection (RAD) tests are available, however, there is scanty data on the performance of RAD tests. OBJECTIVE: To evaluate the performance of the commercially available BIOCREDIT COVID-19 Ag test and compare it with RT-PCR for detecting Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) virus. Analytical sensitivity for the detection of SARS-CoV-2 virus was determined for the RAD test using viral culture and RT-PCR as reference methods. The RAD test was further evaluated using respiratory samples collected from confirmed COVID-19 patients. The results were compared with RT-PCR test. RESULTS: The detection limits between RAD test, viral culture and RT-PCR varied hugely. RAD was 103 fold less sensitive than viral culture while RAD was 105 fold less sensitive than RT-PCR. The RAD test detected between 11.1 % and 45.7 % of RT-PCR-positive samples from COVID-19 patients. CONCLUSIONS: This study demonstrated that the RAD test serves only as adjunct to RT-PCR test because of potential for false-negative results.

Antigens, Viral/analysis , Betacoronavirus/immunology , Clinical Laboratory Techniques/methods , Coronavirus Infections/diagnosis , Immunoassay/methods , Pneumonia, Viral/diagnosis , COVID-19 , COVID-19 Testing , Humans , Pandemics , SARS-CoV-2 , Sensitivity and Specificity