Use Of Rapid Diagnostic Tests Research Articles

Reducing antimicrobial overuse through targeted therapy for patients with community-acquired pneumonia: a study protocol for a cluster-randomized factorial controlled trial (CARE-CAP)

BackgroundCommunity-acquired pneumonia (CAP) is a significant public health concern and a leading cause of hospitalization and inpatient antimicrobial use in the USA. However, determining the etiologic pathogen is challenging because traditional culture methods are slow and insensitive, leading to prolonged empiric therapy with extended-spectrum antibiotics (ESA) that contributes to increased hospital length of stay, and antimicrobial resistance. Two potential ways to reduce the exposure to ESA are (a) rapid diagnostic assays that can provide accurate results within hours, obviating the need for empiric therapy, and (b) de-escalation following negative bacterial cultures in clinically stable patients.MethodsWe will conduct a large pragmatic 2 × 2 factorial cluster-randomized controlled trial across 12 hospitals in the Cleveland Clinic Health System that will test these two approaches to reducing the use of ESA in adult patients (age ≥ 18 years) with CAP. We will enroll over 12,000 patients and evaluate the independent and combined effects of routine use of rapid diagnostic testing at admission and pharmacist-led de-escalation after 48 h for clinically stable patients with negative cultures vs usual care. We hypothesize that both approaches will reduce days on ESA. Our primary outcome is the duration of exposure to ESA therapy, a key driver of antimicrobial resistance. Secondary outcomes include detection of respiratory viruses, treatment with anti-viral medications, positive pneumococcal urinary antigen test, de-escalation by 72 h from admission, re-escalation to ESA after de-escalation, total duration of any antibiotic, 14-day in-hospital mortality, intensive care unit transfer after admission, healthcare-associated C. difficile infection, acute kidney injury, total inpatient cost, and hospital length-of-stay.DiscussionOur study aims to determine whether identifying an etiological agent early and pharmacist-led de-escalation (calling attention to negative cultures) can safely reduce the use of ESA in patients with CAP. If successful, our findings should lead to better antimicrobial stewardship, as well as improved patient outcomes and reduced healthcare costs. Our findings may also inform clinical guidelines on the optimal management of CAP.Trial registrationClinicalTrials.gov NCT05568654. Registered on October 4, 2022.

Challenges in the Management of Invasive Fungal Infections in the Middle East: Expert Opinion to Optimize Management Using a Multidisciplinary Approach.

Invasive fungal infection (IFI) is a significant global healthcare concern among critically ill and immunocompromised patients. In Middle Eastern countries, IFI has been steadily increasing among hospitalized patients in the past two decades. Diagnosis of IFI at an early stage is crucial for efficient management. Invasive fungal infection management is complex and requires the involvement of physicians from different specialties. There are several challenges associated with IFI management in the countries in the Middle East. This review aims to understand the key challenges associated with IFI management in the Middle East, encompassing epidemiology, diagnosis, therapeutic options, and optimizing a multidisciplinary approach. In addition, this review aims to incorporate expert opinions from multidisciplinary fields for optimizing IFI management in different Middle Eastern countries by addressing key decision points throughout the patient's journey. Lack of epidemiological data on fungal infections, slow and poorly sensitive conventional culture-based diagnostic tests, limited availability of biomarker testing, lack of awareness of clinical symptoms of the disease, limited knowledge on fungal infections, lack of local practice guidelines, and complicated disease management are the major challenges associated with IFI diagnosis and management in the Middle Eastern countries. Implementation of a multidisciplinary approach, antifungal stewardship, improved knowledge of fungal infections, the use of rapid diagnostic tests, and enhanced epidemiological research are warranted to lower the IFI burden in the Middle East.

Plasmodium falciparum with pfhrp2/3 Deletion Not Detected in a 2018-2021 Malaria Longitudinal Cohort Study in Kinshasa Province, Democratic Republic of the Congo.

Histidine-rich protein 2- (HRP2-) based rapid diagnostic tests (RDTs) are widely used to detect Plasmodium falciparum in sub-Saharan Africa. Reports of parasites with pfhrp2 and/or pfhrp3 (pfhrp2/3) gene deletions in Africa raise concerns about the long-term viability of HRP2-based RDTs. We evaluated changes in pfhrp2/3 deletion prevalence over time using a 2018-2021 longitudinal study of 1,635 enrolled individuals in Kinshasa Province, Democratic Republic of the Congo (DRC). Samples collected during biannual household visits with ≥ 100 parasites/µL by quantitative real-time polymerase chain reaction were genotyped using a multiplex real-time PCR assay. Among 2,726 P. falciparum PCR-positive samples collected from 993 participants during the study period, 1,267 (46.5%) were genotyped. No pfhrp2/3 deletions or mixed pfhrp2/3-intact and -deleted infections were identified in our study. Pfhrp2/3-deleted parasites were not detected in Kinshasa Province; ongoing use of HRP2-based RDTs is appropriate.

A COMPARATIVE STUDY OF RAPID SARS COV 2 ANTIGEN DETECTION TEST & REAL TIME PCR TEST FOR DIAGNOSIS OF COVID-19 IN TERTIARY CARE INSTITUTE AT KOTA, SOUTH-EAST RAJASTHAN, INDIA

Background:The 2019 (Covid19) pandemic of coronavirus disease was caused by SARS Cov 2 Virus. The emergence of the disease was started from the Wuhan city of China in December 20191. This infection causes asymptomatic and mild diseases more than severe pneumonia. A Rapid Lateral flow immunoassays using monoclonal anti-SARS CoV- 2 antibodies, targeting SARS-CoV-2 antigens, can be used as complementary screening tests if their accuracy comes comparable to that of gold standard real-time RT-PCR assays. Objective:The present study has been conducted retrospectively on the data of patients who underwent for Covid 19 diagnosis by RAT at the Microbiology Department Central Laboratory, Maharao Bhim Singh Hospital Nayapura Kota. Material and Method: Respiratory samples from suspected 5219 COVID-19 patients, mainly nasopharyngeal and throat swabs were collected. COVID-19 Ag Confirmit™ kit (Alpine biomedicals) is a rapidchromatographic immunoassay for the detection ofSARS-CoV-2 nucleoprotein (N) antigen in respiratoryspecimens. Multiplex Real-time RT-PCR kit (TRIVITRON healthcare) was used, whichtargets envelope gene (E), and Orf1ab gene of SARS-CoV-2 genome and RPP30 Human gene as internal control, was used for SARS-CoV-2RNA detection. Descriptive statistics were used to describe the usefulness of rapid diagnostic tests. For that online MedCalcs Diagnostic test evaluation statistical tool10. Result: Among all 5219 samples (n=5219) tested by RT-PCR 785 (15.4%) samples were positive and 4434 (84.95%) were negative. Samples tested by RAT 813 (15.57%) samples were positive & 4406 (84.42%) were negative, in our study we found discordant results in 36 samples. The sensitivity and specificity of the COVID-19 Ag Confirmit™ kit (Alpine biomedicals) were 99.49% and 99.28% respectively. Discussion: Out of 785 RT-PCR-positive samples in our study, the 4 false negative results were tested for SARS-CoV-2 antigen seven days after disease onset. The RT-PCR result of these samples had relatively high Ct-values. Without the present population prevalence of COVID-19, the positive and negative predictive values (PPV and NPV) of the assay could not be accurately calculated. Conclusions: There is comparable Sensitivity and Specificity between Rapid assay for SARS-CoV-2 antigen detection (COVID-19 Ag Confirmit™ kit) and real-time RT-PCR assay.

Antigen concentration, viral load, and test performance for SARS-CoV-2 in multiple specimen types.

The relationship between N-antigen concentration and viral load within and across different specimens guides the clinical performance of rapid diagnostic tests (RDT) in different uses. A prospective study was conducted in Porto Velho, Brazil, to investigate RDT performance in different specimen types as a function of the correlation between antigen concentration and viral load. The study included 214 close contacts with recent exposures to confirmed cases, aged 12 years and older and with various levels of vaccination. Antigen concentration was measured in nasopharyngeal swab (NPS), anterior nares swab (ANS), and saliva specimens. Reverse transcriptase (RT)-PCR was conducted on the NPS and saliva specimens, and two RDTs were conducted on ANS and one RDT on saliva. Antigen concentration correlated well with viral load when measured in the same specimen type but not across specimen types. Antigen levels were higher in symptomatic cases compared to asymptomatic/oligosymptomatic cases and lower in saliva compared to NPS and ANS samples. Discordant results between the RDTs conducted on ANS and the RT-PCR on NPS were resolved by antigen concentration values. The analytical limit-of-detection of RDTs can be used to predict the performance of the tests in populations for which the antigen concentration is known. The antigen dynamics across different sample types observed in SARS-CoV-2 disease progression support use of RDTs with nasal samples. Given lower antigen concentrations in saliva, rapid testing using saliva is expected to require improved RDT analytical sensitivity to achieve clinical sensitivity similar to rapid testing of nasal samples.

Expanding the scope of the infectious diseases pharmacist in HCT: Beyond antimicrobial stewardship.

Infectious disease (ID) pharmacists and antimicrobial stewardship (AMS) programs are integral to the infection management of hematopoietic cell transplant (HCT) recipients demonstrating effective implementation of clinical pathways, de-escalation of empirical antibiotics for febrile neutropenia (FN), allergy assessments, and use of rapid diagnostic testing. The HCT procedure is complex, dynamic, and a high risk for infectious complications. Therefore, there is an important role for an ID and AMS pharmacist to collaborate with the primary treating team, with ongoing care, involving the optimal individual patient prophylactic, pre-emptive and treatment management of infections in this high-risk population. This review highlights key factors for consideration of ID/AMS Pharmacists in relation to HCT, including important aspects in the evaluation of infection risk prior to transplant, risk from donor sources, length of, and changes in immunosuppression, and potential drug-drug interactions from other essential supportive care therapies.

Investigating the etiology of acute febrile illness: a prospective clinic-based study in Uganda

BackgroundHistorically, malaria has been the predominant cause of acute febrile illness (AFI) in sub-Saharan Africa. However, during the last two decades, malaria incidence has declined due to concerted public health control efforts, including the widespread use of rapid diagnostic tests leading to increased recognition of non-malarial AFI etiologies. Our understanding of non-malarial AFI is limited due to lack of laboratory diagnostic capacity. We aimed to determine the etiology of AFI in three distinct regions of Uganda.MethodsA prospective clinic-based study that enrolled participants from April 2011 to January 2013 using standard diagnostic tests. Participant recruitment was from St. Paul’s Health Centre (HC) IV, Ndejje HC IV, and Adumi HC IV in the western, central and northern regions, which differ by climate, environment, and population density. A Pearson's chi-square test was used to evaluate categorical variables, while a two-sample t-test and Krukalis-Wallis test were used for continuous variables.ResultsOf the 1281 participants, 450 (35.1%), 382 (29.8%), and 449 (35.1%) were recruited from the western, central, and northern regions, respectively. The median age (range) was 18 (2–93) years; 717 (56%) of the participants were female. At least one AFI pathogen was identified in 1054 (82.3%) participants; one or more non-malarial AFI pathogens were identified in 894 (69.8%) participants. The non-malarial AFI pathogens identified were chikungunya virus, 716 (55.9%); Spotted Fever Group rickettsia (SFGR), 336 (26.2%) and Typhus Group rickettsia (TGR), 97 (7.6%); typhoid fever (TF), 74 (5.8%); West Nile virus, 7 (0.5%); dengue virus, 10 (0.8%) and leptospirosis, 2 (0.2%) cases. No cases of brucellosis were identified. Malaria was diagnosed either concurrently or alone in 404 (31.5%) and 160 (12.5%) participants, respectively. In 227 (17.7%) participants, no cause of infection was identified. There were statistically significant differences in the occurrence and distribution of TF, TGR and SFGR, with TF and TGR observed more frequently in the western region (p = 0.001; p < 0.001) while SFGR in the northern region (p < 0.001).ConclusionMalaria, arboviral infections, and rickettsioses are major causes of AFI in Uganda. Development of a Multiplexed Point-of-Care test would help identify the etiology of non-malarial AFI in regions with high AFI rates.

Rapid Diagnostic Test Value and Implementation in Antimicrobial Stewardship Across Low-to-Middle and High-Income Countries: A Mixed-Methods Review.

Despite technological advancements in infectious disease rapid diagnostic tests (RDTs) and use to direct therapy at the per-patient level, RDT utilisation in antimicrobial stewardship programmes (ASPs) is variable across low-to-middle income and high-income countries. Key insights from a panel of seven infectious disease experts from Colombia, Japan, Nigeria, Thailand, the UK, and the USA, combined with evidence from a literature review, were used to assess the value of RDTs in ASPs. From this, a value framework is proposed which aims to define the benefits of RDT use in ASPs, separate from per-patient benefits. Expert insights highlight that, to realise the value of RDTs within ASPs, effective implementation is key; actionable advice for choosing an RDT is proposed. Experts advocate the inclusion of RDTs in the World Health Organization Model List of essential in vitro diagnostics and in iterative development of national action plans.

Use of rapid diagnostic tests for the detection of ancient malaria infections in dental pulp from the sixth century in Versailles, France

BackgroundPaleomicrobiological data have clarified that Plasmodium spp. was circulating in the past in southern European populations, which are now devoid of malaria. The aim of this study was to evaluate the efficacy of immunodetection and, more particularly, rapid diagnostic tests (RDT), in order to further assess Plasmodium infections in ancient northern European populations.MethodsA commercially available RDT, PALUTOP® + 4 OPTIMA, which is routinely used to detect malaria, was used to detect Plasmodium antigens from proteins recovered from ancient specimens extracted from 39 dental pulp samples. These samples were collected from 39 individuals who were buried in the sixth century, near the site of the current Palace of Versailles in France. Positive and negative controls were also used. Antigens detected were quantified using chemiluminescence imaging system analysis.ResultsPlasmodium antigens were detected in 14/39 (35.9%) individuals, including Plasmodium vivax antigens in 11 individuals and Plasmodium falciparum antigens co-detected in two individuals, while Pan-Plasmodium antigens were detected in three individuals. Controls all yielded expected results.ConclusionsThe data reported here showed that RDTs are a suitable tool for detecting Plasmodium spp. antigens in ancient dental pulp samples, and demonstrated the existence of malaria in Versailles, France, in the sixth century. Plasmodium vivax, which is regarded as being responsible for an attenuated form of malaria and less deadly forms, was the most prevalent species. This illustrates, for the first time in ancient populations, co-infection with P. falciparum, bringing into question the climate-driven ecosystems prevailing at that time in the Versailles area.

Quantitative Polymerase Chain Reaction from Malaria Rapid Diagnostic Tests to Detect Borrelia crocidurae, the Agent of Tick-Borne Relapsing Fever, in Febrile Patients in Senegal.

In endemic malaria areas, Plasmodium is currently diagnosed mainly through the use of rapid diagnostic tests (RDTs). However, in Senegal, many causes of fever remain unknown. Tick-borne relapsing fever, an often-neglected public health problem, is the main cause of consultation for acute febrile illness after malaria and flu in rural areas. Our objective was to test the feasibility of extracting and amplifying DNA fragments by quantitative polymerase chain reaction (qPCR) from malaria-negative RDTs for Plasmodium falciparum (malaria Neg RDTs P.f) to detect Borrelia spp. and other bacteria. Between January and December 2019, malaria Neg RDTs P.f were collected on a quarterly basis in 12 health facilities in four regions of Senegal. The DNA extracted from the malaria Neg RDTs P.f was tested using qPCR and the results were confirmed by standard PCR and sequencing. Only Borrelia crocidurae DNA was detected in 7.22% (159/2,202) of RDTs. The prevalence of B. crocidurae DNA was higher in July (16.47%, 43/261) and August (11.21%, 50/446). The annual prevalence was 9.2% (47/512) and 5.0% (12/241) in Ngayokhem and Nema-Nding, respectively, health facilities in the Fatick region. Our study confirms that B. crocidurae infection is a frequent cause of fever in Senegal, with a high prevalence of cases in health facilities in the regions of Fatick and Kaffrine. Malaria Neg RDTs P.f are potentially a good source of pathogen sampling for the molecular identification of other causes of fever of unknown origin, even in the most remote areas.

Diagnostic performance of two rapid tests for syphilis screening in people living with HIV in Cali, Colombia.

There is insufficient evidence supporting the use of rapid diagnostic tests (RDTs) for syphilis in people living with HIV (PLWH). We evaluated the diagnostic performance of two commercially available RDTs (Bioline and Determine) in PLWH in Cali, Colombia. A cross-sectional field validation study on consecutive adults with confirmed HIV diagnosis attending three outpatient clinics. Both RDTs were performed on capillary blood (CB), obtained by finger prick, and sera, by venipuncture. A combination of treponemal enzyme linked immunosorbent assay (ELISA) and Treponema pallidum haemagglutination assay (TPHA) on serum samples was the reference standard. Rapid plasma reagin (RPR) and clinical criteria were added to define active syphilis. Sensitivity and specificity, predictive values and likelihood ratios (LR) of RDTs were estimated with their corresponding 95% confidence interval (95% CI). Stratified analyses by sample type, patient characteristics, non-treponemal titers, operator and re-training were performed. 244 PLWH were enrolled, of whom 112 (46%) had positive treponemal reference tests and 26/234 (11.1%) had active syphilis. The sensitivities of Bioline on CB and sera were similar (96.4% vs 94.6%, p = 0.6). In contrast, Determine had a lower sensitivity on CB than sera (87.5% vs 99.1%, p<0.001). Sensitivities were lower in PLWH not receiving ART (Bioline 87.1% and Determine 64.5%, p<0.001) and for one of the operators (Bioline 85% and Determine 60%, p<0.001). Specificities of the RDTs were > 95% in most analyses. Predictive values were 90% or higher. For active syphilis, the RDTs showed a similar performance pattern but with decreased specificities. The studied RDTs have an excellent performance in PLWH to screen for syphilis and potentially for active syphilis, yet Determine performs better on sera than CB. Patient characteristics and potential difficulties operators may face in acquiring enough blood volume from finger pricks should be considered for the implementation and the interpretation of RDTs.

Characteristics of hospitalized COVID-19 patients with other respiratory pathogens identified by rapid diagnostic test

Rapid diagnostic tests (RDTs) significantly impact disease treatment strategy. In Japan, information on the use of RDTs for patients with COVID-19 is limited. Here, we aimed to investigate the RDT implementation rate, pathogen detection rate, and clinical characteristics of patients positive for other pathogens by using COVIREGI-JP, a national registry of hospitalized patients with COVID-19.A total of 42,309 COVID-19 patients were included. For immunochromatographic testing, influenza was the most common (n = 2881 [6.8%]), followed by Mycoplasma pneumoniae (n = 2129 [5%]) and group A streptococcus (GAS) (n = 372 [0.9%]). Urine antigen testing was performed for 5524 (13.1%) patients for S. pneumoniae and for 5326 patients (12.6%) for L. pneumophila.The completion rate of M. pneumonia loop-mediated isothermal amplification (LAMP) testing was low (n = 97 [0.2%]). FilmArray RP was performed in 372 (0.9%) patients; 1.2% (36/2881) of patients were positive for influenza, 0.9% (2/223) for the respiratory syncytial virus (RSV), 9.6% (205/2129) for M. pneumoniae, and 7.3% (27/372) for GAS. The positivity rate for urine antigen testing was 3.3% (183/5524) for S. pneumoniae and 0.2% (13/5326) for L. pneumophila. The positivity rate for LAMP test was 5.2% (5/97) for M. pneumoniae. Five of 372 patients (1.3%) had positive FilmArray RP, with human enterovirus being the most frequently detected (1.3%, 5/372).The characteristics of patients with and without RDTs submission and positive and negative results differed for each pathogen. RDTs remain an important diagnostic tool in patients with COVID-19 in whom coinfection with other pathogens needs to be tested based on clinical evaluation.

Nasopharyngeal rapid diagnostic testing to reduce unnecessary antibiotic use and individualize management of acute otitis media.

Acute otitis media (AOM) is the most common indication for antibiotics in children. The associated organism can influence the likelihood of antibiotic benefit and optimal treatment. Nasopharyngeal polymerase chain reaction can effectively exclude the presence of organisms in middle-ear fluid. We explored the potential cost-effectiveness and reduction in antibiotics with nasopharyngeal rapid diagnostic testing (RDT) to direct AOM management. We developed 2 algorithms for AOM management based on nasopharyngeal bacterial otopathogens. The algorithms provide recommendations on prescribing strategy (ie, immediate, delayed, or observation) and antimicrobial agent. The primary outcome was the incremental cost-effectiveness ratio (ICER) expressed as cost per quality-adjusted life day (QALD) gained. We used a decision-analytic model to evaluate the cost-effectiveness of the RDT algorithms compared to usual care from a societal perspective and the potential reduction in annual antibiotics used. An RDT algorithm that used immediate prescribing, delayed prescribing, and observation based on pathogen (RDT-DP) had an ICER of $1,336.15 per QALD compared with usual care. At an RDT cost of $278.56, the ICER for RDT-DP exceeded the willingness to pay threshold; however, if the RDT cost was <$212.10, the ICER was below the threshold. The use of RDT was estimated to reduced annual antibiotic use, including broad-spectrum antimicrobial use, by 55.7% ($4.7 million for RDT vs $10.5 million for usual care). The use of a nasopharyngeal RDT for AOM could be cost-effective and substantially reduce unnecessary antibiotic use. These iterative algorithms could be modified to guide management of AOM as pathogen epidemiology and resistance evolve.

Is there a role for RDTs as we live with COVID-19? An assessment of different strategies

IntroductionBy 2022, high levels of past COVID-19 infections, combined with substantial levels of vaccination and the development of Omicron, have shifted country strategies towards burden reduction policies. SARS-CoV-2 rapid antigen...

Availability and use of rapid diagnostic tests for the management of acute childhood infections in Europe: A cross-sectional survey of paediatricians.

Point-of-care-tests (POCTs) have been advocated to optimise care in patients with infections but their actual use varies. This study aimed to estimate the variability in the adoption of current POCTs by paediatricians across Europe, and to explore the determinants of variability. A cross-sectional survey was conducted of hospital and primary care paediatricians, recruited through professional networks. Questions focused on the availability and use of currently available POCTs. Data were analysed descriptively and using Median Odds Ratio (MOR) to measure variation between countries. Multilevel regression modelling using changes in the area under the receiver operating characteristic curve of models were used to assess the contribution of individual or workplace versus country level factors, to the observed variation. The commonest POCT was urine dipsticks (UD) which were available to >80% of primary care and hospital paediatricians in 68% (13/19) and 79% (23/29) countries, respectively. Availability of all POCTs varied between countries. In primary care, the country (MOR) varied from 1.61 (95%CI: 1.04-2.58) for lactate to 7.28 (95%CI: 3.04-24.35) for UD. In hospitals, the country MOR varied from 1.37 (95%CI:1.04-1.80) for lactate to 11.93 (95%CI:3.35-72.23) for UD. Most paediatricians in primary care (69%, 795/1154) and hospital (81%, 962/1188) would use a diagnostic test in the case scenario of an infant with undifferentiated fever. Multilevel regression modelling showed that the country of work was more important in predicting both the availability and use of POCTs than individual or workplace characteristics. There is substantial variability in the adoption of POCTs for the management of acute infections in children across Europe. To inform future implementation of both existing and innovative tests, further research is needed to understand what drives the variation between countries, the needs of frontline clinicians, and the role of diagnostic tests in the management of acute childhood infections.

187. Nasopharyngeal Testing to Individualize Management of Acute Otitis Media

Abstract Background There are &amp;gt; 10 million antibiotics prescribed yearly for acute otitis media (AOM). The associated organism can influence the likelihood of antibiotic benefit and optimal treatment. A rapid diagnostic test (RDT) for AOM could prevent unnecessary antibiotic use, while assuring those likely to benefit from antibiotics receive the appropriate agent. Nasopharyngeal (NP) polymerase chain reaction can effectively exclude the presence of organisms in middle ear fluid and may be useful to individualize care. Objective: To explore the potential cost-effectiveness and reduction in antibiotics with NP RDTs to direct AOM management. Methods We developed two algorithms for AOM management based on NP bacterial otopathogens (Figure1). The algorithms provide recommendations on prescribing strategy (immediate, delayed, or observation) and antimicrobial agent. We utilized a tiering system based on expected pathogen-associated severity and resistance. The primary outcome was the incremental cost-effectiveness ratio (ICER) expressed as cost per quality adjusted life day gained (QALD). We used a decision-analytic model to evaluate the cost-effectiveness of the RDT algorithms compared to usual care from a societal perspective over a 30-day time horizon. Secondary outcomes included the (1) cost at which a RDT would be cost-effective and (2) potential reduction in annual antibiotics used. Flow diagram Figure 1:Flow diagram for management of AOM including RDT-DP and RDT-OBS algorithms Results An RDT algorithm that used immediate, delayed prescribing, and observation based on pathogen (RDT-DP) had an ICER of $1336.15/QALD compared with usual care and strongly dominated the RDT that used only immediate prescribing and observation (RDT-OBS). At an RDT cost of $278.56, the ICER for RDT-DP exceeded the willingness to pay threshold ($274 per QALD gained); however, if the cost of the RDT was &amp;lt; $212.10, the ICER was below the threshold. Both algorithms reduced annual antibiotic use, including broad-spectrum use, compared to usual care (RDT-DP 4.7 million (56% reduction), RDT-OBS 5.4 million (49% reduction), usual care 10.5 million). Conclusion The use of a NP RDT for AOM is likely to be cost-effective and substantially reduce unnecessary antibiotic use. These iterative algorithms could be modified to guide AOM management as scientific knowledge evolves. Disclosures All Authors: No reported disclosures.

"Testing for malaria does not cure any pain" A qualitative study exploring low use of malaria rapid diagnostic tests at drug shops in rural Uganda.

The World Health Organization recommends all suspected malaria cases be confirmed with a parasitological test, typically a rapid diagnostic test (RDT), prior to treatment. Despite recommendations, many fevers presenting at private drug shops are treated presumptively as malaria without diagnostic testing. The purpose of this qualitative study was to describe community perceptions of RDTs and explore ways to improve malaria case management at drug shops in Bugoye, western Uganda. A total of 63 in-depth interviews were conducted between September and December 2021 with 24 drug shop clients, 19 drug shop vendors, 12 community health workers, and 8 health and community officials. Data was analyzed using thematic content analysis and narrative techniques. While drug shop clients valued RDTs, the cost of the test limited their use. Further, mistrust in negative results and fear about treatment options for conditions other than malaria led to nonadherence to negative RDTs. Improvement with antimalarials after a negative RDT, or no RDT at all, was seen as proof an individual had malaria, reinforcing the acceptability of liberal antimalarial use. Drug shop vendors were knowledgeable about malaria case management but financially conflicted between recommending best practices and losing business. While clients viewed drug shop vendors as trusted health professionals, health officials distrusted them as business owners focused on maximizing profits. Study results suggest public-private partnerships that recognize the essential role of drug shops, better incorporate them into the healthcare system, and leverage the high levels of community trust in vendors, could provide greater opportunities for oversight and training to improve private-sector malaria case management. Interventions that address financial barriers to RDT use, emphasize the financial benefits of malaria testing, increase vendor knowledge about illnesses confused with malaria, and improve the quality of vendor-client counseling could increase RDT uptake and improve adherence to RDT results.

Comparative laboratory diagnosis of malaria: Microscopy versus rapid diagnostic test kits in a tertiary institution of North-Central Nigeria

Laboratory diagnosis of malaria is a vital key for its effective management. Diagnosis of malaria includes rapid, sensitive, and specific test methods. This study was aimed to assess the diagnostic performance of PfHRP2 rapid malaria test with reference to light microscopy for the diagnosis of malaria at the Bingham University Teaching Hospital (BhUTH) Jos –Plateau State, Nigeria. A total of 150 febrile patients attending BHUTH who were sent to the Hospital Laboratory from the General out patients Department (GOPD) for malaria parasite test (MPT)request had their blood sample collected and tested for malaria parasites (MP) using Field Stain A and B stain microscopy and PfHRP2 rapid malaria test between September and November 2021.Results shows that the sensitivity and specificity of PfHRP2 rapid malaria were 9.23% and 90.0% respectively, with corresponding positive and negative predictive values (PPV) as 90.0%and (NPV) as13. 2%. PfHRP2 rapid malaria test showed good sensitivity and specificity that is in agreement with that of the reference light microscopy. The rapid diagnostic test (RDT) results compared well with the light microscopy (Gold standard) for Laboratory diagnosis for malaria. Sustained use of RDT as an alternative to light microscopy is recommended especially in malaria endemic areas and the rural communities where electricity is out of reach.

Evaluation of the diagnostic performance of PanbioTM Abbott SARS-CoV-2 rapid antigen test for the detection of COVID-19 from suspects attending ALERT center.

The emergence and rapid spread of coronavirus disease 2019 (COVID-19), a potentially lethal disease caused by severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), is causing public health issues around the world. In resource-constrained nations, rapid Abbott SARS-CoV-2 antigen test kits are critical for addressing diagnostic gaps in health institutions and community screening. However, there is no evidence or proof of diagnostic performance in Ethiopia. The aim of this study was to compare the performance of PanbioTM Abbott SARS-CoV-2antigen rapid test kit to the gold standard, RT-PCR, in COVID-19 patients with clinical symptoms suggestive of COVID-19. A prospective, cross-sectional study was conducted between November 2021 and April 2022, on 120 suspected patients recruited from outpatient, emergency, and intensive care units in one of the tertiary hospitals in Ethiopia. Nasopharyngeal swabs were collected from suspected cases and were tested using the Abbott SARS-CoV-2 kit, a rapid diagnostic test (RDT) and compared to the reference standard RT-PCR. The sensitivity and specificity of the RDT were 74.2% and 100%, respectively. A total of 62 samples (51.6%) were RT-PCR positive. Of these, 46 were Ag-RDT positive. Sensitivity among symptomatic patients was 79.4% (95% CI 68.3-90). The Abbot RDT and RT-PCR had a Kappa value of agreement of 0.735 (p < 0.001). These values were acceptable when compared to the WHO's suggested thresholds. The finding from this study support the use of the Abbot RDT as a diagnostic tool in COVID-19 suspects, mainly in those with higher viral loads.

Barriers and facilitators to HIV and syphilis rapid diagnostic testing in antenatal care settings in low-income and middle-income countries: a systematic review

BackgroundTesting and treatment during pregnancy is a well-established and cost-effective prevention strategy, which relies largely on use of rapid diagnostic tests (RDTs). Yet, in many low-income and-middle-income countries, the uptake...