ABSTRACT
ImportanceThe antigen-based rapid diagnostic test (Ag-RDT), using saliva specimens, is fast, non-invasive and suitable for SARS-CoV-2 self-testing, unlike nasopharyngeal swab (NPS) testing. ObjectiveTo assess the diagnostic sensitivity of a novel Beanguard gargle (BG)-based virus detection method for early diagnosis of COVID-19. DesignThis clinical trial was conducted at Gunsan Medical Center, Namwon Medical Center, and Jeonbuk National University Hospital, between May 7 and July 7, 2021. SettingPaired NPS and BG-based saliva specimens collected from COVID-19 patients and healthy individuals were analyzed using NPS-RT-PCR, BG-RT-PCR, and BG-Ag-RDTs. ParticipantsThe study comprised 102 COVID-19-positive patients hospitalized after governmental screening process and 100 healthy individuals. Forty-five COVID-19 patients were sampled within 6 days of illness and 57 within 7-15 days; 27 were categorized as asymptomatic and 75, as symptomatic. Eight and 2 patients carried the SARS-CoV-2 Alpha and Delta variants, respectively. InterventionThe diagnostic performances of BG-Ag-RDT, BG-RT-PCR, and NPS-RT-PCR for detecting SARS-CoV-2 were compared. Main outcomesThe sensitivities of BG-Ag-RDT and BG-RT-PCR towards salivary viral detection were highly concordant, with no discrimination between symptomatic, asymptomatic, or SARS-CoV-2 variant cases. ResultsAmong total participants (mean age, 43.7 years), 51% were women. BG-Ag-RDTs showed high sensitivity (97.8%, [95% CI, 88.4% to 99.6%]) and specificity (100%, [95% CI, 96.3% to 100%) in 45 patients within 6 days of illness and could detect all cases of SARS-CoV-2 Alpha and Delta variants. In 11 asymptomatic early-stage cases, both BG-Ag-RDTs and BG-RT-PCR showed excellent sensitivity and specificity of 100% (95% CI, 74.1% to 100% and 95% CI, 20.7% to 100%, respectively). The interaction between SARS-CoV-2 spike proteins and truncated canavalin, an active ingredient from bean extract (BE) and the ultrastructural features of SARS-CoV-2 particles coated with BE were observed. The detachment of the SARS-CoV-2 receptor-binding domain from hACE2 increased as the BE concentration increased, allowing the release of the virus from hACE2 for early diagnosis. Conclusions and RelevanceUsing BG-based saliva remarkably enhances the Ag-RDT diagnostic performance as an alternative to NPS and enables rapid and accurate COVID-19 self-testing and mass screening, supporting efficient COVID-19 management. Trial RegistrationKCT0006438 Key PointsO_ST_ABSQuestionC_ST_ABSHow can we collect SARS-CoV-2 from oral cavity to improve the sensitivity of antigen-based rapid diagnostic test (Ag-RDT)? FindingsIn this clinical study involving 102 hospitalized COVID-19 patients, the Ag-RDT test using Beanguard gargle-based saliva specimens showed significantly enhanced sensitivity and specificity towards detection of SARS-CoV-2 along with Alpha and Delta variants in all patients tested within 6 days of illness. MeaningOur self-testing method represents an attractive alternative to nasopharyngeal swab RT-PCR for the early diagnosis of symptomatic and asymptomatic COVID-19 cases.
ABSTRACT
B₃ is a rare finding, but it is most common in the B subgroup, which been reported as being 0.025% of the total B group in Koreans. ABO*B3.01 is a specific allele for B₃, a missense mutation with a substituted thymine from cytosine of the 1,054th nucleotide of the ABO*B.01 allele, but rather unexpectedly, it has not been reported in Koreans. We report here the first Korean case of the serological Aâ‚B₃ phenotype with ABO*B3.01, which was confirmed by sequencing of exons 6 and 7 of the ABO gene, found in a pregnant woman.
ABSTRACT
BACKGROUND: Clinical microbiological tests are conducted at night, on weekends, and during public holidays in various manners due to the fact that both manual processes and the form of working type, are not well known. Therefore, we surveyed the current running condition of these laboratories and made some suggestions for better-quality clinical microbiology tests. METHODS: We conducted a survey, both online and offline, focusing on the operating styles of clinical microbiological tests within laboratories that had participated in an external quality assessment program, conducted by the Korean Association of External Quality Assessment Service (KEQAS). RESULTS: Out of 341 laboratories that participated in the microbiology program of KEQAS, 128 replied to our questionnaires. In Korea, various types of operations occur within clinical microbiology laboratories. Those in night duty operate in either shifts or dedicated duties. In the case of weekend shifts, they either operated on single-day schedules (either on a Saturday or a Sunday), or over the entire weekend. For public holidays, the laboratories operated in various manners, depending on the number of days off. Among the clinical microbiological tests conducted at night, on weekends, and during public holidays, Gram staining and inoculations are the most common tasks carried out, with some laboratories conducting antibiotic susceptibility tests as well. CONCLUSIONS: Rapid reporting of clinical microbiological test results is currently inadequate due to both cost and labor constraints, despite its many advantages. It would be ultimately beneficial for both the patient and the hospital to switch to a 24/7 operating schedule through the utilization of a variety of methods, including cost control, coordination of a fine workforce, and prioritization of tests needing to be reported.
Subject(s)
Humans , Appointments and Schedules , Consensus , Cost Control , Holidays , Korea , RunningABSTRACT
An ABO-incompatible transfusion is a very rare event but it can cause severe adverse effects, including death. The prognosis is affected by various factors, such as the volume of infusion, underlying diseases, and immunologic state. Until now, however, there has been no consensus regarding the treatment of an ABO-incompatible transfusion except for conservative treatment. A 57 year-old male patient visited the authors' emergency unit with multiple trauma due to a car accident. He had a deep laceration on his left neck accompanied by severe bleeding. Because of his low blood pressure and low hemoglobin level due to bleeding, an emergency transfusion was attempted. Unfortunately, one unit of RBC was transfused incorrectly into the patient due to a clerical error during the identification of the patient. The patient was typed as O, RhD positive; the RBC administered was A, RhD positive. After the transfusion, the patient showed an acute hemolytic transfusion reaction due to gross hematuria. Plasma exchange was attempted and medical treatment with high dose steroid with diuretics was done simultaneously. Two cycles of plasma exchange were done and the patient appeared to recover from the acute adverse effects of the transfusion. The plasma exchange was stopped and medical treatments for the transfusion reactions were maintained for ten days. The patient recovered fully and was discharged after one month. Based on this case, although more studies are necessary for approval as a standard therapy, this case suggests that immediate plasma exchange with medical treatment can be very helpful for eliminating the isoagglutinins in ABO-incompatible transfusions.
