-
Journal of Pharmacy & Bioallied Sciences Apr 2024May-Thurner syndrome (MTS) is an anatomical condition of external luminal compression of common iliac vein due to a partial obstruction of the common iliac vein between... (Review)
Review
May-Thurner syndrome (MTS) is an anatomical condition of external luminal compression of common iliac vein due to a partial obstruction of the common iliac vein between common iliac artery and lumbar vertebra causes deep-vein thrombosis, venous hypertension, and chronic venous insufficiencies. In this article, we review present evidence of the clinical diagnosis and management of MTS. Here, we conducted a literature review of studies on MTS. We also reviewed different clinical features, presentation, diagnostic methods, and therapeutic procedure for this condition. Most studies mentioned the diagnosis of this condition is performed by color Doppler, computed tomographic angiography, venography, and problem-solving cases by intravascular ultrasound technique. Nonsurgical methods of management are first line, and vascular surgery is reserved for refractory cases. Multiple modalities are required to reach the diagnosis of MTS, and noninvasive intervention radiology methods are the first line of management. This review highlights the presentations of MTS and outlines diagnostic procedure and management.
PubMed: 38882842
DOI: 10.4103/jpbs.jpbs_1135_23 -
Journal of Vascular Surgery Aug 2023To investigate the long-term reinterventions of thoracic endovascular repair (TEVAR) after blunt traumatic aortic injury. (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
To investigate the long-term reinterventions of thoracic endovascular repair (TEVAR) after blunt traumatic aortic injury.
METHODS
MEDLINE, EMBASE, and Cochrane databases were interrogated until June 2021. Inclusion criteria were blunt traumatic aortic injury treated with TEVAR and mean follow-up of more than 60 months. A systematic review was conducted and data were pooled using a random effects model of proportions applying the Freeman-Tukey transformation. Late reintervention was the primary outcome. Secondary outcomes were procedure-related complications (endoleak, in-stent thrombosis, occlusion, infolding/collapse, bird-beak, migration, and left arm claudication), overall and aortic-related mortality, and aortic diameter changes.
RESULTS
Eleven studies with a low quality assessment were included. Four hundred eight patients were collected and the 389 surviving more than 30 days were included. The mean follow-up was 8.2 years (95% confidence interval [CI], 5.7-10.8; I = 40.2%). Late reintervention was 2.1% (95% CI, 0.6-3.9; I = 0.0%; 11/389 cases) with 0.1% (95% CI, 0.0-1.2; I = 0.0%; 3/389) occurring after 5 years. Bird-beak was identified in 38.7% (95% CI, 16.4-63.6; I = 86.6%). Left arm claudication occurring after 30 days was 3.1% (95% CI, 0.1-8.6; I = 26.9%; 11/140 cases). In-stent thrombosis was 1.9% (95% CI, 0.1-5.2; I = 51.8%; 11/389 cases). Endoleak was 0.5% (95% CI, 0.0-1.9; I = 0.0%; 5/389 cases). Infolding, occlusion, and migration were reported in 2 of 389, 1 of 389, and 0 of 389 patients, respectively. Overall late survival was 95.6% (95% CI, 88.1-99.8; I = 84.7%; 358/389 patients) and only one patient accounted for aortic related mortality. The increase in proximal and distal aortic diameters was estimated at 2.7 mm (95% CI, 1.2-4.3; I = 0.0%) and 2.5 mm (95% CI, 1.1-3.9; I = 0.0%), respectively.
CONCLUSIONS
TEVAR demonstrates remarkably good long-term results and reinterventions are rarely required. Aortic reinterventions tend to occur within the first and after the fifth year.
Topics: Humans; Blood Vessel Prosthesis; Blood Vessel Prosthesis Implantation; Aorta, Thoracic; Stents; Endoleak; Treatment Outcome; Endovascular Procedures; Retrospective Studies; Wounds, Nonpenetrating
PubMed: 36754248
DOI: 10.1016/j.jvs.2023.01.196 -
The Cochrane Database of Systematic... Jul 2023Lower extremity atherosclerotic disease (LEAD) - also known as peripheral arterial disease - refers to the obstruction or narrowing of the large arteries of the lower... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Lower extremity atherosclerotic disease (LEAD) - also known as peripheral arterial disease - refers to the obstruction or narrowing of the large arteries of the lower limbs, most commonly caused by atheromatous plaque. Although in many cases of less severe disease patients can be asymptomatic, the major clinical manifestations of LEAD are intermittent claudication (IC) and critical limb ischaemia, also known as chronic limb-threatening ischaemia (CLTI). Revascularisation procedures including angioplasty, stenting, and bypass grafting may be required for those in whom the disease is severe or does not improve with non-surgical interventions. Maintaining vessel patency after revascularisation remains a challenge for vascular surgeons, since approximately 30% of vein grafts may present with restenosis in the first year due to myointimal hyperplasia. Restenosis can also occur after angioplasty and stenting. Restenosis and occlusions that occur more than two years after the procedure are generally related to progression of the atherosclerosis. Surveillance programmes with duplex ultrasound (DUS) scanning as part of postoperative care may facilitate early diagnosis of restenosis and help avoid amputation in people who have undergone revascularisation.
OBJECTIVES
To assess the effects of DUS versus pulse palpation, arterial pressure index, angiography, or any combination of these, for surveillance of lower limb revascularisation in people with LEAD.
SEARCH METHODS
The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, CINAHL, and LILACS databases and World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers to 1 February 2022.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) and quasi-RCTs that compared DUS surveillance after lower limb revascularisation versus clinical surveillance characterised by medical examination with pulse palpation, with or without any other objective test, such as arterial pressure index measures (e.g. ankle-brachial index (ABI) or toe brachial index (TBI)). Our primary outcomes were limb salvage rate, vessel or graft secondary patency, and adverse events resulting from DUS surveillance. Secondary outcomes were all-cause mortality, functional walking ability assessed by walking distance, clinical severity scales, quality of life (QoL), re-intervention rates, and functional walking ability assessed by any validated walking impairment questionnaire. We presented the outcomes at two time points: two years or less after the original revascularisation (short term) and more than two years after the original revascularisation (long term).
DATA COLLECTION AND ANALYSIS
We used standard Cochrane methodological procedures. We used the Cochrane RoB 1 tool to assess the risk of bias for RCTs and GRADE to assess the certainty of evidence. We performed meta-analysis when appropriate.
MAIN RESULTS
We included three studies (1092 participants) that compared DUS plus pulse palpation and arterial pressure index (ABI or TBI) versus pulse palpation and arterial pressure index (ABI or TBI) for surveillance of lower limb revascularisation with bypass. One study each was conducted in Sweden and Finland, and the third study was conducted in the UK and Europe. The studies did not report adverse events resulting from DUS surveillance, functional walking ability, or clinical severity scales. No study assessed surveillance with DUS scanning after angioplasty or stenting, or both. We downgraded the certainty of evidence for risk of bias and imprecision. Duplex ultrasound plus pulse palpation and arterial pressure index (ABI or TBI) versus pulse palpation plus arterial pressure index (ABI or TBI) (short-term time point) In the short term, DUS surveillance may lead to little or no difference in limb salvage rate (risk ratio (RR) 0.84, 95% confidence interval (CI) 0.49 to 1.45; I² = 93%; 2 studies, 936 participants; low-certainty evidence) and vein graft secondary patency (RR 0.92, 95% CI 0.67 to 1.26; I² = 57%; 3 studies, 1092 participants; low-certainty evidence). DUS may lead to little or no difference in all-cause mortality (RR 1.11, 95% CI 0.70 to 1.74; 1 study, 594 participants; low-certainty evidence). There was no clear difference in QoL as assessed by the 36-item Short Form Health Survey (SF-36) physical score (mean difference (MD) 2 higher, 95% CI 2.59 lower to 6.59 higher; 1 study, 594 participants; low-certainty evidence); the SF-36 mental score (MD 3 higher, 95% CI 0.38 lower to 6.38 higher; 1 study, 594 participants; low-certainty evidence); or the EQ-5D utility score (MD 0.02 higher, 95% CI 0.03 lower to 0.07 higher; 1 study, 594 participants; low-certainty evidence). DUS may increase re-intervention rates when considered any therapeutic intervention (RR 1.38, 95% CI 1.05 to 1.81; 3 studies, 1092 participants; low-certainty evidence) or angiogram procedures (RR 1.53, 95% CI 1.12 to 2.08; 3 studies, 1092 participants; low-certainty evidence). Duplex ultrasound plus pulse palpation and arterial pressure index (ABI or TBI) versus pulse palpation plus arterial pressure index (ABI or TBI) (long-term time point) One study reported data after two years, but provided only vessel or graft secondary patency data. DUS may lead to little or no difference in vessel or graft secondary patency (RR 0.83, 95% CI 0.19 to 3.51; 1 study, 156 participants; low-certainty evidence). Other outcomes of interest were not reported at the long-term time point.
AUTHORS' CONCLUSIONS
Based on low certainty evidence, we found no clear difference between DUS and standard surveillance in preventing limb amputation, morbidity, and mortality after lower limb revascularisation. We found no studies on DUS surveillance after angioplasty or stenting (or both), only studies on bypass grafting. High-quality RCTs should be performed to better inform the best medical surveillance of lower limb revascularisation that may reduce the burden of peripheral arterial disease.
Topics: Humans; Lower Extremity; Angioplasty; Peripheral Arterial Disease; Intermittent Claudication; Stents
PubMed: 37470266
DOI: 10.1002/14651858.CD013852.pub2 -
Progress in Cardiovascular Diseases 2023Mitral valve transcatheter edge-to-edge repair (M-TEER) is a minimally invasive method for the treatment of mitral regurgitation (MR) in patients with prohibitive... (Meta-Analysis)
Meta-Analysis Review
Transcatheter edge-to-edge repair in mitral regurgitation: A comparison of device systems and recommendations for tailored device selection. A systematic review and meta-analysis.
BACKGROUND
Mitral valve transcatheter edge-to-edge repair (M-TEER) is a minimally invasive method for the treatment of mitral regurgitation (MR) in patients with prohibitive surgical risks. The traditionally used device, MitraClip, showed both safety and effectiveness in M-TEER. PASCAL is a newer device that has emerged as another feasible option to be used in this procedure.
METHODS
We searched for observational studies that compared PASCAL to MitraClip devices in M-TEER. The electronic databases searched for relevant studies were PubMed/MEDLINE, Scopus, and Embase. The primary outcomes were technical success and the grade of MR at follow-up. Secondary outcomes included all-cause mortality, bleeding, device success and reintervention.
RESULTS
Technical success (PASCAL: 96.5% vs MitraClip: 97.6%, p = 0.24) and MR ≤ 2 at 30-day follow-up (PASCAL: 89.4vs MitraClip 89.9%, p = 0.51) were comparable between both groups. Both devices showed similar outcomes including all-cause mortality (RR: 0.68 [0.34, 1.38]; P = 0.28), major bleeding (RR: 1.87 [0.68, 5.10]; P = 0.22) and reintervention (RR: 1.02 [0.33, 3.16]; P = 0.97). Device success was more frequent with PASCAL device (PASCAL: 86% vs MitraClip 68.5%; P = 0.44), however, the results did not reach statistical significance.
CONCLUSION
Clinical outcomes of PASCAL were comparable to those of MitraClip with no significant difference in safety and effectiveness. The choice between MitraClip and PASCAL devices should be guided by various factors, including mitral valve anatomy, etiology of regurgitation, and device-specific characteristics.
Topics: Humans; Mitral Valve Insufficiency; Treatment Outcome; Mitral Valve; Cardiac Surgical Procedures; Heart Valve Prosthesis Implantation; Cardiac Catheterization
PubMed: 37924965
DOI: 10.1016/j.pcad.2023.10.008 -
European Journal of Vascular and... Dec 2023Pre-procedural planning of thoracic endovascular aortic repair (TEVAR) may implement computational adjuncts to predict technical and clinical outcomes. The aim of this... (Review)
Review
OBJECTIVE
Pre-procedural planning of thoracic endovascular aortic repair (TEVAR) may implement computational adjuncts to predict technical and clinical outcomes. The aim of this scoping review was to explore the currently available TEVAR procedure and stent graft modelling options.
DATA SOURCES
PubMed (MEDLINE), Scopus, and Web of Science were systematically searched (English language, up to 9 December 2022) for studies presenting a virtual thoracic stent graft model or TEVAR simulation.
REVIEW METHODS
The Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews (PRISMA-ScR) was followed. Qualitative and quantitative data were extracted, compared, grouped, and described. Quality assessment was performed using a 16 item rating rubric.
RESULTS
Fourteen studies were included. Among the currently available in silico simulations of TEVAR, severe heterogeneity exists in study characteristics, methodological details, and evaluated outcomes. Ten studies (71.4%) were published during the last five years. Eleven studies (78.6%) included heterogeneous clinical data to reconstruct patient specific aortic anatomy and disease (e.g., type B aortic dissection, thoracic aortic aneurysm) from computed tomography angiography imaging. Three studies (21.4%) constructed idealised aortic models with literature input. The applied numerical methods consisted of computational fluid dynamics analysing aortic haemodynamics in three studies (21.4%) and finite element analysis analysing structural mechanics in the others (78.6%), including or excluding aortic wall mechanical properties. The thoracic stent graft was modelled as two separate components (e.g., graft, nitinol) in 10 studies (71.4%), as a one component homogenised approximation (n = 3, 21.4%), or including nitinol rings only (n = 1, 7.1%). Other simulation components included the catheter for virtual TEVAR deployment and numerous outcomes (e.g., Von Mises stresses, stent graft apposition, drag forces) were evaluated.
CONCLUSION
This scoping review identified 14 severely heterogeneous TEVAR simulation models, mostly of intermediate quality. The review concludes there is a need for continuous collaborative efforts to improve the homogeneity, credibility, and reliability of TEVAR simulations.
Topics: Humans; Blood Vessel Prosthesis; Endovascular Aneurysm Repair; Aorta, Thoracic; Stents; Blood Vessel Prosthesis Implantation; Reproducibility of Results; Endovascular Procedures; Postoperative Complications; Treatment Outcome; Aortic Aneurysm, Thoracic; Retrospective Studies
PubMed: 37330201
DOI: 10.1016/j.ejvs.2023.06.006 -
Updates in Surgery Aug 2023Rare complication of gallstone disease is gallstone ileus. The common location is the small intestine, followed by the stomach. The rarest location is colonic gallstone...
Rare complication of gallstone disease is gallstone ileus. The common location is the small intestine, followed by the stomach. The rarest location is colonic gallstone ileus (CGI). To summarize and define the most appropriate diagnostic methods and therapeutic options for CGI based on the paucity of published data. Literature searches of English-, German-, Spanish-, Italian-, Japanese-, Dutch- and Portuguese language articles included and Italian-language articles using PubMed, EMBASE, Web of Science, The Cochrane Library, and Google Scholar. Additional studies were identified from the references of retrieved studies. 113 cases of CGI were recorded with a male to female patient ratio of 1:2.9. The average patient age was 77.7 years (range 45-95 years). The usual location of stone impaction was the sigmoid colon (85.8%), followed by a descending colon (6.6%), transverse colon (4.7%), rectum (1.9%), and lastly, ascending colon (0.9%). Gallstones ranged from 2 to 10 cm. The duration of symptoms was variable (1 day to 2 months), with commonly reported abdominal distension, obstipation, and vomiting; 85.2% of patients had previous biliary symptoms. Diverticular disease was present in 81.8% of patients. During the last 23 years, CT scan was the most common imaging method (91.5%), confirming the ectopic gallstone in 86.7% of cases, pneumobilia in 65.3%, and cholecytocolonic fistula in 68%. The treatment option included laparotomy with cololithotomy and primary closure (24.7%), laparotomy and cololithotomy with diverting stoma (14.2%), colonic resection with anastomosis (7.9%), colonic resection with a colostomy (12.4%), laparoscopy with cololithotomy with primary closure (2.6%), laparoscopy with cololithotomy with a colostomy (0.9%), colostomy without gallstone extraction (5.3%), endoscopic mechanical lithotripsy (success rate 41.1%), extracorporeal shock wave lithotripsy (1.8%). The cholecystectomy rate was 46.7%; during the initial procedure 25%, and as a separate procedure, 21.7%; 53.3% of patients had no cholecystectomy. The survival rate was 87%. CGI is the rarest presentation of gallstone ileus, mainly in women over 70 years of age, with gallstones over 2 cm, and predominantly in the sigmoid colon. Abdominal CT is diagnostic. Nonoperative treatment, particularly in subacute presentations, should be the first-line treatment. Laparotomy with cololithotomy or colonic resection is a standard procedure with favorable outcomes. There are no robust data on whether primary or delayed cholecystectomy is mandatory as a part of CGI management.
Topics: Humans; Female; Male; Aged; Aged, 80 and over; Middle Aged; Gallstones; Ileus; Sigmoid Diseases; Intestinal Obstruction; Algorithms
PubMed: 37209317
DOI: 10.1007/s13304-023-01537-0 -
Journal of Medical Imaging and... Mar 2024Interventional radiology employs minimally invasive image-guided procedures for diagnosing and treating various conditions. Among these procedures, alcohol and thermal... (Review)
Review
BACKGROUND
Interventional radiology employs minimally invasive image-guided procedures for diagnosing and treating various conditions. Among these procedures, alcohol and thermal ablation techniques have shown high efficacy. However, these procedures present challenges such as increased procedure time, radiation dose, and risk of tissue injury. This scoping review aims to explore how augmented reality (AR) can mitigate these challenges and improve the accuracy, precision, and efficiency of image-guided tumor ablation while improving patient outcomes.
METHODS
A scoping review of the literature was performed based on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews (PRISMA-ScR) guideline to identify published literature investigating AR in image-guided tumor ablations. We conducted our electronic searches using PubMed, Scopus, Web of Sciences and CINAHL from inception to April 27th, 2023. The following Boolean terms were used for the search: ("augmented reality" OR "AR" OR "navigation system" OR "head mounted device" OR "HMD") AND ("tumor ablation" OR "radiofrequency tumor ablation" OR "microwave tumor ablation" OR "cryoablation"). We considered articles eligible for our scoping review if they met the following conditions: (1) published in English only, (2) focused on image-guided tumour ablations, (3) incorporated AR techniques in their methodology, (4) employed an aspect of AR in image-guided tumour ablations, and (5) exclusively involved human subjects. Publications were excluded if there was no mention of applying AR, or if the study investigated interventions other than image-guided tumour ablations.
RESULTS
Our search results yielded 1,676 articles in our initial search of the databases. Of those, 409 studies were removed as duplicates. 1,243 studies were excluded during the title and abstract screening. 24 studies were assessed for eligibility in the full-text stage. 19 studies were excluded, resulting in a final selection of only five studies that satisfied our inclusion criteria. The studies aimed to assess AR's efficacy in tumor ablations. Two studies compared an optical-based AR system with CT guidance. Two studies used a head-mounted AR device, while one used a dual-camera setup. Various tumor types were examined, including bone, abdominal soft tissue, breast, hepatic, renal, colorectal, and lung lesions. All studies showed positive results, including reduced radiation exposure, shorter procedures, and improved navigation, and targeting assistance.
CONCLUSION
AR systems enhance image-guided tumor ablations by improving the accuracy of ablation probe placements and increasing efficiency. They offer real-time guidance, enhanced visualization, and improved navigation, resulting in optimal needle placement. AR reduces radiation exposure and shortens procedure times compared to traditional CT-guided techniques. However, limitations like small sample sizes and technical challenges require further research. Despite this, AR shows potential benefits and larger, diverse studies are needed for validation.
Topics: Humans; Augmented Reality; Neoplasms; Liver
PubMed: 38290953
DOI: 10.1016/j.jmir.2023.12.006 -
Journal of Vascular and Interventional... Sep 2023To assess the efficacy and safety of middle meningeal artery (MMA) embolization with liquid embolic agents and the outcomes of patients following this procedure. (Meta-Analysis)
Meta-Analysis Review
PURPOSE
To assess the efficacy and safety of middle meningeal artery (MMA) embolization with liquid embolic agents and the outcomes of patients following this procedure.
MATERIALS AND METHODS
A review of the literature was conducted to identify studies investigating the efficacy and safety of MMA embolization with liquid embolic agents in patients with chronic subdural hematoma (cSDH) in PubMed, Scopus, Embase, and Web of Science. The keywords "liquid embolic agent," "middle meningeal artery," "cSDH," and "embolization" as well as their synonyms were used to build up the search strategy. The R statistical software and random-effects model were used for analysis. Heterogeneity was reported as I, and publication bias was calculated using the Egger test.
RESULTS
Of 628 articles retrieved, 14 studies were eligible to be included in this study. Data of 276 patients were analyzed. n-Butyl cyanoacrylate and ethylene vinyl alcohol copolymer were the most commonly used embolic agents. This study revealed a pooled mortality rate of 0% (95% confidence interval [CI], 0.00%-100%), recurrence and failure rate of 3% (95% CI, 1%-10%), reoperation/reintervention rate of 4% (95% CI, 2%-12%), rate of size decrease of 94% (95% CI, 79%-98%), technical success rate of 100% (95% CI, 76%-100%), and adverse event rate of 1% (95% CI, 0.00%-4%).
CONCLUSIONS
With low mortality, recurrence, reoperation, and adverse event rates and a remarkable decrease in the size of hematomas, MMA embolization with liquid embolic agents may be considered a safe and effective treatment option in patients in whom surgical intervention has previously failed and as an alternative to conventional treatments.
Topics: Humans; Hematoma, Subdural, Chronic; Meningeal Arteries; Treatment Outcome; Embolization, Therapeutic; Reoperation
PubMed: 37182671
DOI: 10.1016/j.jvir.2023.05.010 -
Clinical Neuroradiology Sep 2023Acute intracranial large vessel occlusion (LVO) is an important cause of morbidity and mortality among children; however, unlike in adults, no clinical trial has... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Acute intracranial large vessel occlusion (LVO) is an important cause of morbidity and mortality among children; however, unlike in adults, no clinical trial has investigated the benefit of mechanical thrombectomy (MT) in pediatric LVO. Thus, MT remains an off-label procedure for pediatric stroke.
PURPOSE
To investigate the efficacy and safety of MT in pediatric LVO.
METHODS
A systematic literature search was conducted in Ovid MEDLINE, Ovid Embase, Scopus, Web of Science, and Cochrane Central Register of Clinical Trials databases. Studies reporting safety and efficacy outcomes for endovascular treatment of pediatric LVO were included. Data regarding recanalization, functional outcome, symptomatic intracranial hemorrhage (sICH), and mortality were extracted from the included studies. Functional outcome was assessed with the modified Rankin scale (mRS). A fixed or random-effects model was used to calculate pooled event rates and 95% confidence intervals (CI).
RESULTS
In this study 11 studies comprising 215 patients were included. The successful recanalization rate was 90.3% (95% CI = 85.77-95.11%), and complete recanalization was achieved in 52.7% (95% CI = 45.09-61.62%) of the cases. The favorable (mRS = 0-2) and excellent (mRS = 0-1) outcome rates were 83.3% (95% CI = 73.54-94.50%) and 59.5% (95% CI = 44.24-80.06%), respectively. The overall sICH prevalence was 0.59% (95% CI = 0-3.30%) and mortality rate was 3.2% (95% CI = 0.55-7.38%).
CONCLUSION
In our meta-analysis, MT demonstrated a promising safety and efficacy profile for pediatric patients, with consistently high efficacy outcomes and low complication rates. Our results support the utilization of MT in pediatric LVOs; however, prospective studies are still needed to further establish the role of pediatric MT as a first-line treatment strategy.
Topics: Humans; Child; Brain Ischemia; Thrombectomy; Stroke; Intracranial Hemorrhages; Prospective Studies; Treatment Outcome
PubMed: 36592199
DOI: 10.1007/s00062-022-01246-y -
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