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The Medical Journal of Australia Dec 2023To review evaluations of the diagnostic accuracy of coronavirus disease 2019 (COVID-19) rapid antigen tests (RATs) approved by the Therapeutic Goods Administration (TGA)... (Review)
Review
COVID-19 rapid antigen tests approved for self-testing in Australia: published diagnostic test accuracy studies and manufacturer-supplied information. A systematic review.
OBJECTIVES
To review evaluations of the diagnostic accuracy of coronavirus disease 2019 (COVID-19) rapid antigen tests (RATs) approved by the Therapeutic Goods Administration (TGA) for self-testing by ambulatory people in Australia; to compare these estimates with values reported by test manufacturers.
STUDY DESIGN
Systematic review of publications in any language that reported cross-sectional, case-control, or cohort studies in which the participants were ambulatory people in the community or health care workers in hospitals in whom severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection was suspected, and the results of testing self-collected biological samples with a TGA-approved COVID-19 RAT were compared with those of reverse transcription-polymerase chain reaction (RT-PCR) testing for SARS-CoV-2. Estimates of diagnostic accuracy (sensitivity, specificity) were checked and compared with manufacturer estimates published on the TGA website.
DATA SOURCES
Publications (to 1 September 2022) identified in the Cochrane COVID-19 Study Register and the World Health Organization COVID-19 research database. Information on manufacturer diagnostic accuracy evaluations was obtained from the TGA website.
DATA SYNTHESIS
Twelve publications that reported a total of eighteen evaluations of eight RATs approved by the TGA for self-testing (manufacturers: All Test, Roche, Flowflex, MP Biomedicals, Clungene, Panbio, V-Chek, Whistling) were identified. Five studies were undertaken in the Netherlands, two each in Germany and the United States, and one each in Denmark, Belgium, and Canada; test sample collection was unsupervised in twelve studies, and supervised by health care workers or researchers in six. Estimated sensitivity with unsupervised sample collection ranged from 20.9% (MP Biomedicals) to 74.3% (Roche), and with supervised collection from 7.7% (V-Chek) to 84.4% (Panbio); the estimates were between 8.2 and 88 percentage points lower than the values reported by the manufacturers. Test specificity was high for all RATs (97.9-100%).
CONCLUSIONS
The risk of false negative results when using COVID-19 RATs for self-testing may be considerably higher than apparent in manufacturer reports on the TGA website, with implications for the reliability of these tests for ruling out infection.
Topics: Humans; COVID-19; SARS-CoV-2; Self-Testing; Cross-Sectional Studies; Reproducibility of Results; Sensitivity and Specificity; Diagnostic Tests, Routine; COVID-19 Testing
PubMed: 37903650
DOI: 10.5694/mja2.52151 -
Infectious Diseases of Poverty Oct 2023The complexity of the Chagas disease and its phases is impossible to have a unique test for both phases and a lot of different epidemiological scenarios. Currently,... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
The complexity of the Chagas disease and its phases is impossible to have a unique test for both phases and a lot of different epidemiological scenarios. Currently, serology is the reference standard technique; occasionally, results are inconclusive, and a different diagnostic technique is needed. Some guidelines recommend molecular testing. A systematic review and meta-analysis of available molecular tools/techniques for the diagnosis of Chagas disease was performed to measure their heterogeneity and efficacy in detecting Trypanosoma cruzi infection in blood samples.
METHODS
A systematic review was conducted up to July 27, 2022, including studies published in international databases. Inclusion and exclusion criteria were defined to select eligible studies. Data were extracted and presented according to PRISMA 2020 guidelines. Study quality was assessed using Quality Assessment of Diagnostic Accuracy Studies-2 (QUADAS-2). A random-effects model was used to calculate pooled sensitivity, specificity, and diagnostic odds ratio (DOR). Forest plots and a summary of the receiving operating characteristics (SROC) curves displayed the outcomes. Heterogeneity was determined by I and Tau statistics and P values. Funnel plots and Deek's test were used to assess publication bias. A quantitative meta-analysis of the different outcomes in the two different clinical phases was performed.
RESULTS
We identified 858 records and selected 32 papers. Studies pertained to endemic countries and nonendemic areas with adult and paediatric populations. The sample sizes ranged from 17 to 708 patients. There were no concerns regarding the risk of bias and applicability of all included studies. A positive and nonsignificant correlation coefficient (S = 0.020; P = 0.992) was obtained in the set of studies that evaluated diagnostic tests in the acute phase population (ACD). A positive and significant correlation coefficient (S = 0.597; P < 0.000) was obtained in the case of studies performed in the chronic phase population (CCD). This resulted in high heterogeneity between studies, with the master mix origin and guanidine addition representing significant sources.
INTERPRETATION/CONCLUSIONS AND RELEVANCE
The results described in this meta-analysis (qualitative and quantitative analyses) do not allow the selection of the optimal protocol of molecular method for the study of Trypanosoma cruzi infection in any of its phases, among other reasons due to the complexity of this infection. Continuous analysis and optimization of the different molecular techniques is crucial to implement this efficient diagnosis in endemic areas.
Topics: Adult; Child; Humans; Sensitivity and Specificity; Chagas Disease
PubMed: 37845734
DOI: 10.1186/s40249-023-01143-7 -
Heliyon Sep 2023Azivudine has undergone a few randomized controlled trials (RCTs) as of late. This study aimed to assess the COVID-19 treatment with azvudine's efficacy and safety. (Review)
Review
INTRODUCTION
Azivudine has undergone a few randomized controlled trials (RCTs) as of late. This study aimed to assess the COVID-19 treatment with azvudine's efficacy and safety.
METHODS
Through January 20, 2023, systematic searches of PubMed, Embase, ClinicalTrials.gov, International Clinical Trials Registry Platform (ICTRP), Cochrane Central Register of Controlled Trials (CENTRAL), and MedRxiv were conducted to find the RCTs. The included studies' bias risk was evaluated using the Cochrane Handbook for Systematic Reviews of Interventions. Meta-analysis was performed using Revman 5.4 (PROSPERO Code: CRD42023395022).
RESULTS
A total of five RCTs with 1142 COVID-19 patients, 575 of whom received azvudine, were included. Additionally, seven RCTs are currently being conducted. In terms of clinical improvement and PT-PCR (reverse transcription polymerase chain reaction) negativity, the azvudine group had a greater patient percentage than the usual treatment or placebo group. It also took less time for the PT-PCR to become negative. In comparison to the placebo or standard treatment groups, the frequency of adverse events was reduced in the azvudine group (risk ratio [RR] = 0.89, 95% confidence interval [CI]: 0.80 to 0.99) and major adverse events (RR = 0.63, 95% CI: 0.22 to 1.79) groups.
CONCLUSIONS
Without the burden of side effects, azvudine can hasten the clinical symptoms of COVID-19 patients and PT-PCR negative. It will take more extensive research to confirm these conclusions.
PubMed: 37809649
DOI: 10.1016/j.heliyon.2023.e20153 -
Survey of Ophthalmology 2024Acute retinal necrosis is a progressive intraocular inflammatory syndrome characterized by diffuse necrotizing retinitis that can lead to a poor visual outcome, mainly... (Meta-Analysis)
Meta-Analysis Review
Acute retinal necrosis is a progressive intraocular inflammatory syndrome characterized by diffuse necrotizing retinitis that can lead to a poor visual outcome, mainly from retinal detachment. The antiviral treatment approach for acute retinal necrosis varies as there are no established guidelines. We summarize the outcomes of acute retinal necrosis with available antiviral treatments. Electronic searches were conducted in PubMed/MEDLINE, EMBASE, Scopus, and Google Scholar for interventional and observational studies. Meta-analysis was performed to evaluate the pooled proportion of the predefined selected outcomes. This study was registered in PROSPERO (CRD42022320987). Thirty-four studies with a total of 963 participants and 1,090 eyes were included in the final analysis. The estimated varicella-zoster virus and herpes simplex virus polymerase chain reaction-positive cases were 63% (95% CI: 55-71%) and 35% (95% CI: 28-42%), respectively. The 3 main antiviral treatment approaches identified were oral antivirals alone, intravenous antivirals alone, and a combination of systemic (oral or intravenous) and intravitreal antivirals. The overall pooled estimated proportions of visual acuity improvement, recurrence, and retinal detachment were 37% (95% CI: 27-47%), 14% (95% CI: 8-21%), and 43% (95% CI: 38-50%), respectively. Patients treated with systemic and intravitreal antivirals showed a trend towards better visual outcomes than those treated with systemic antivirals (oral or intravenous) alone, even though this analysis was not statistically significant (test for subgroup differences P = 0.83).
Topics: Humans; Retinal Necrosis Syndrome, Acute; Antiviral Agents; Acyclovir; Eye Infections, Viral; Retinal Detachment; Retrospective Studies
PubMed: 37774799
DOI: 10.1016/j.survophthal.2023.09.004 -
Ticks and Tick-borne Diseases Jan 2024Published data on tick-borne pathogens (TBPs) in camels worldwide have been collected to provide an overview of the global prevalence and species diversity of camelid... (Meta-Analysis)
Meta-Analysis Review
Published data on tick-borne pathogens (TBPs) in camels worldwide have been collected to provide an overview of the global prevalence and species diversity of camelid TBPs. Several TBPs have been detected in dromedary camels, raising concerns regarding their role as natural or maintenance hosts for tick-borne pathogens. Insubstantial evidence exists regarding the natural infection of camels with Babesia spp., Theileria spp., Anaplasma spp., and Ehrlichia spp., particularly because most of the camels were considered healthy at the time of sampling. Based on polymerase chain reaction (PCR) testing, a pooled prevalence of 35.3% (95% CI: 22.6-48.1%) was estimated for Anaplasma, which was the most frequently tested TBP in dromedaries, and DNA of Anaplasma marginale, Anaplasma centrale, Anaplasma ovis, Anaplasma platys, and A. platys-like were isolated, of which ruminants and dogs are reservoirs. Similarly, the estimated pooled prevalence for the two piroplasmid genera; Babesia and Theileria was approximately equal (10-12%) regardless of the detection method (microscopy or PCR testing). Nevertheless, Babesia caballi, Theileria equi, and Theileria annulata DNA have frequently been detected in camels but they have not yet been proven to be natural hosts. Scarce data detected Babesia microti, Anaplasma phagocytophilum, and Borrelia burgdorferi sensu lato (s.l.) DNA in blood of dromedaries, although ticks of the genus Ixodes are distributed in limited areas where dromedaries are raised. Interestingly, a pooled seroprevalence of 47.7% (26.3-69.2%) was estimated for Crimean-Congo hemorrhagic fever virus, and viral RNA was detected in dromedary blood; however, their contribution to maintain the viral transmission cycles requires further experimental investigation. The substantially low incidence and scarcity of data on Rickettsia and Ehrlichia species could imply that camels were accidentally infected. In contrast, camels may play a role in the spread of Coxiella burnetii, which is primarily transmitted through the inhalation of aerosols emitted by diseased animals and contaminated environments. Bactrian camels showed no symptoms due to the examined TBPs, meanwhile, clinical disease was seen in alpacas infected with A. phagocytophilum. Similar to dromedaries, accidental tick bites may be the cause of TBP DNA found in the blood of Bactrian camels.
Topics: Animals; Dogs; Camelus; Prevalence; Seroepidemiologic Studies; Ehrlichia; Rickettsia; Anaplasma; Babesia; Ixodes; Theileria annulata; DNA; Tick-Borne Diseases; Dog Diseases
PubMed: 37769585
DOI: 10.1016/j.ttbdis.2023.102268 -
Genes Aug 2023Stem cells have been associated with self-renewing and plasticity and have been investigated in various odontogenic lesions in association with their pathogenesis and... (Review)
Review
BACKGROUND
Stem cells have been associated with self-renewing and plasticity and have been investigated in various odontogenic lesions in association with their pathogenesis and biological behavior. We aim to provide a systematic review of stem cell markers' expression in odontogenic tumors and cysts.
METHODS
The literature was searched through the MEDLINE/PubMed, EMBASE via OVID, Web of Science, and CINHAL via EBSCO databases for original studies evaluating stem cell markers' expression in different odontogenic tumors/cysts, or an odontogenic disease group and a control group. The studies' risk of bias (RoB) was assessed via a Joanna Briggs Institute Critical Appraisal Tool. Meta-analysis was conducted for markers evaluated in the same pair of odontogenic tumors/cysts in at least two studies.
RESULTS
29 studies reported the expression of stem cell markers, e.g., SOX2, OCT4, NANOG, CD44, ALDH1, BMI1, and CD105, in various odontogenic lesions, through immunohistochemistry/immunofluorescence, polymerase chain reaction, flow cytometry, microarrays, and RNA-sequencing. Low, moderate, and high RoBs were observed in seven, nine, and thirteen studies, respectively. Meta-analysis revealed a remarkable discriminative ability of SOX2 for ameloblastic carcinomas or odontogenic keratocysts over ameloblastomas.
CONCLUSION
Stem cells might be linked to the pathogenesis and clinical behavior of odontogenic pathologies and represent a potential target for future individualized therapies.
PubMed: 37761874
DOI: 10.3390/genes14091735 -
Frontiers in Oncology 2023Breast Cancer (BC) stands out as the widely prevalent malignancy among all the types of cancer affecting women worldwide. There is significant evidence that the...
BACKGROUND
Breast Cancer (BC) stands out as the widely prevalent malignancy among all the types of cancer affecting women worldwide. There is significant evidence that the pathogenicity of BC may be altered by Human Papillomavirus (HPV) infection; however, conclusive data are not yet available.
METHODS
By searching five databases, including EMBASE, IBECS, PubMed, Scopus, Science Direct, Google Scholar, and Web of Science, a thorough systematic analysis was conducted on the prevalence of HPV in BC patients from 1990 to June 30, 2022. After applying extensive eligibility criteria, we selected 74 publications for further analysis based on the prevalence of HPV infections in breast tissues. All of the data were analyzed using a random-effects meta-analysis, Cochran Q test and statistic were used to calculate the heterogeneity of the prevalence among these studies using subgroup analysis. Variations in the HPV prevalence estimates in different subgroups were evaluated by subgroup meta-analysis.
RESULTS
In total, 3156 studies were initially screened, resulting in 93 full-text studies reviewed, with 74 meeting inclusion criteria. Among a total of 7156 BC biopsies, the pool prevalence of HPV was 25.6% (95% CI= 0.24-0.33, τ2 = 0.0369 with significant heterogeneity between estimates ( 97% and < 0.01). Consequently, 45 studies with available controls were further studied, and the prevalence of HPV in case-control studies was 26.2% with overall odds 5.55 (95% CI= 3.67-8.41, 38%, τ2 = 1.4878, < 0.01). Further subgroup analysis of HPV revealed HPV-16 had a maximum prevalence of 9.6% (95% CI= 3.06-11.86, 0%, τ2 = 0.6111, 0.01). Among different geographical regions, Europe reported the maximum prevalence of HPV, i.e., 39.2% (95% CI=1.29-7.91, 18%, τ2 = 1.2911, < 0.01). Overall distribution showed HPV-18 was a frequent HPV subtype reported in Australia.
CONCLUSION
Current study provides a global estimate of HPV prevalence in BC patients and demonstrates a significant association between this virus and BC etiology. Nevertheless, we recommend further investigation into the underlying mechanism is essential to validate this hypothesis.
PubMed: 37711194
DOI: 10.3389/fonc.2023.1219161 -
PLoS Medicine Sep 2023Cholera surveillance relies on clinical diagnosis of acute watery diarrhea. Suspected cholera case definitions have high sensitivity but low specificity, challenging our... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Cholera surveillance relies on clinical diagnosis of acute watery diarrhea. Suspected cholera case definitions have high sensitivity but low specificity, challenging our ability to characterize cholera burden and epidemiology. Our objective was to estimate the proportion of clinically suspected cholera that are true Vibrio cholerae infections and identify factors that explain variation in positivity.
METHODS AND FINDINGS
We conducted a systematic review of studies that tested ≥10 suspected cholera cases for V. cholerae O1/O139 using culture, PCR, and/or a rapid diagnostic test. We searched PubMed, Embase, Scopus, and Google Scholar for studies that sampled at least one suspected case between January 1, 2000 and April 19, 2023, to reflect contemporary patterns in V. cholerae positivity. We estimated diagnostic test sensitivity and specificity using a latent class meta-analysis. We estimated V. cholerae positivity using a random-effects meta-analysis, adjusting for test performance. We included 119 studies from 30 countries. V. cholerae positivity was lower in studies with representative sampling and in studies that set minimum ages in suspected case definitions. After adjusting for test performance, on average, 52% (95% credible interval (CrI): 24%, 80%) of suspected cases represented true V. cholerae infections. After adjusting for test performance and study methodology, the odds of a suspected case having a true infection were 5.71 (odds ratio 95% CrI: 1.53, 15.43) times higher when surveillance was initiated in response to an outbreak than in non-outbreak settings. Variation across studies was high, and a limitation of our approach was that we were unable to explain all the heterogeneity with study-level attributes, including diagnostic test used, setting, and case definitions.
CONCLUSIONS
In this study, we found that burden estimates based on suspected cases alone may overestimate the incidence of medically attended cholera by 2-fold. However, accounting for cases missed by traditional clinical surveillance is key to unbiased cholera burden estimates. Given the substantial variability in positivity between settings, extrapolations from suspected to confirmed cases, which is necessary to estimate cholera incidence rates without exhaustive testing, should be based on local data.
Topics: Humans; Cholera; Vibrio cholerae; Disease Outbreaks; Diarrhea; Polymerase Chain Reaction
PubMed: 37708235
DOI: 10.1371/journal.pmed.1004286 -
Open Forum Infectious Diseases Sep 2023Rapid point-of-care testing for respiratory pathogens has gained increasing popularity, but its impact on antibiotic consumption is unclear. Thus, the aim of this... (Review)
Review
The Effect of Rapid Point-of-Care Respiratory Pathogen Testing on Antibiotic Prescriptions in Acute Infections-A Systematic Review and Meta-analysis of Randomized Controlled Trials.
BACKGROUND
Rapid point-of-care testing for respiratory pathogens has gained increasing popularity, but its impact on antibiotic consumption is unclear. Thus, the aim of this systematic review and meta-analysis was to estimate the effect of rapid point-of-care testing on antibiotic prescriptions.
METHODS
The search for this systematic review with meta-analysis was performed in February 2023. Randomized controlled trials investigating the impact of testing for respiratory pathogens in all-aged patients were included regardless of the comparator. The main outcome was the antibiotic prescription rate. Analyses were stratified by test type, test setting, and patient age. A random-effects Mantel-Haenszel model was used to calculate risk ratios with 95% confidence intervals. Risk of bias was assessed for included studies, and the quality of the evidence was rated according to GRADE.
RESULTS
A total of 754 abstracts were screened, and 10 studies were included in the analysis. Risk of bias was high in 2, low in 4, and had some concerns in 4 studies. Four studies analyzed influenza and respiratory syncytial virus tests, and 6 studies analyzed multiplex (viral and/or bacterial) testing. The prescription rate was 48.2% (496/1029) in the influenza and respiratory syncytial virus test group and 48.7% (540/1109) in the control group (risk ratio [RR], 0.97; 95% CI, 0.92-1.02; moderate-quality evidence). The prescription rate in the multiplex testing group was 54.3% (1554/2859), and it was 57.3% (1336/2326) in the control group (RR, 1.00; 95% CI, 0.96-1.04; moderate-quality evidence). In an age-stratified analysis, the prescription rates showed no evidence of a difference (children: RR, 1.03; 95% CI, 0.81-1.30; adults: RR, 0.98; 95% CI, 0.96-1.01; very low- and moderate-quality evidence).
CONCLUSIONS
We found moderate-quality evidence that rapid point-of-care testing for respiratory pathogens does not decrease the antibiotic prescription rate.
PubMed: 37662450
DOI: 10.1093/ofid/ofad443 -
The Malaysian Journal of Medical... Aug 2023Individuals with a history of coronavirus disease 2019 (COVID-19) exhibit memory immunity acquired during natural infection. However, a decline in immunity after... (Review)
Review
Individuals with a history of coronavirus disease 2019 (COVID-19) exhibit memory immunity acquired during natural infection. However, a decline in immunity after infection renders these individuals vulnerable to re-infection, in addition to a higher risk of infection with new variants. This systematic review examined related studies to elucidate the antibody response in these infected individuals after messenger ribonucleic acid (mRNA) vaccination. Hence, the focus of this review was to ascertain differences in the concentration of binding and neutralising antibodies of previously infected individuals in comparison to those of infection-naïve individuals after administration of two doses of mRNA vaccination through available case-control and cohort studies. Positive reverse transcriptase-polymerase chain reaction (RT-PCR) test or detectable anti-severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) antibodies at the baseline in included studies showed categorisation of infected and uninfected individuals. This review utilised three online databases: PubMed, Scopus and Cochrane with the following keywords: (COVID-19 OR 'Coronavirus Disease 2019' OR SARS-CoV-2) AND Immun* AND (Pfizer OR BioNTech OR BNT162b2 OR Comirnaty OR Moderna OR mRNA-1273) from January 2019 to July 2021. Following the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocol (PRISMA-P) 2020 guidelines and assessment based on the Crowe Critical Appraisal Tool (CCAT), we included 13 related qualified papers of observational studies discerning the binding and neutralising antibody concentrations of infected and uninfected individuals after administration of mRNA vaccines, such as the BNT162b2 and mRNA-1273 vaccine. The mRNA vaccines induced robust binding and neutralising antibody responses in both groups. However, infected individuals showed induction of higher antibody responses in a shorter time compared to uninfected individuals. Hence, a single dose of mRNA vaccination for infected individuals may be sufficient to reach the same level of antibody concentration as that observed in uninfected individuals after receiving two doses of vaccination.
PubMed: 37655145
DOI: 10.21315/mjms2023.30.4.2