Brief Communication on MAGE-A4 and Coexpression of Cancer Testis Antigens in Metastatic Synovial Sarcomas: Considerations for Development of Immunotherapeutics.

Therapeutic options for synovial sarcoma (SyS) have not evolved for several decades and the efficacy of second-line treatments is very limited. The expression of a large family of proteins known as cancer testis antigens (CTAs) in SyS has spurred the development of targeted T-cell therapies currently in clinical trials, such as those aimed at melanoma-associated antigen (MAGE)-A4 and New York esophageal squamous cell carcinoma 1 (NY-ESO-1), which have shown promising clinical efficacy. Extensive knowledge of the prevalence of expression and coexpression of CTAs is critical to design T-cell therapies with optimal coverage of the patient population. We analyzed the expression of CTAs of the MAGE-A family as well as NY-ESO-1 and preferentially expressed antigen in melanoma (PRAME) by RNA sequencing in a large cohort of 133 SyS samples from patients registered in the French sarcoma database (NETSARC+). Among MAGE-As, MAGE-A4 had the highest prevalence (65%), followed by MAGE-A10 (15%) and MAGE-A9 (13%). Almost all samples (92%) expressing any of the MAGE-As also expressed MAGE-A4. NY-ESO-1 was expressed in 65% of samples, with a large but incomplete overlap with MAGE-A4, whereas PRAME was present in 121 (91%) samples. Complementary immunohistochemical analyses were used to establish the positive correlation between RNA and protein expression for MAGE-A4 and NY-ESO-1. These data inform the strategy for optimal coverage of the SyS patient population with T-cell therapies, offering patients with SyS new options for single or combined second lines of treatment.

Identifying MAGE-A4-positive tumors for TCR T cell therapies in HLA-A∗02-eligible patients.

T cell receptor (TCR) T cell therapies target tumor antigens in a human leukocyte antigen (HLA)-restricted manner. Biomarker-defined therapies require validation of assays suitable for determination of patient eligibility. For clinical trials evaluating TCR T cell therapies targeting melanoma-associated antigen A4 (MAGE-A4), screening in studies NCT02636855 and NCT04044768 assesses patient eligibility based on: (1) high-resolution HLA typing and (2) tumor MAGE-A4 testing via an immunohistochemical assay in HLA-eligible patients. The HLA/MAGE-A4 assays validation, biomarker data, and their relationship to covariates (demographics, cancer type, histopathology, tissue location) are reported here. HLA-A∗02 eligibility was 44.8% (2,959/6,606) in patients from 43 sites across North America and Europe. While HLA-A∗02:01 was the most frequent HLA-A∗02 allele, others (A∗02:02, A∗02:03, A∗02:06) considerably increased HLA eligibility in Hispanic, Black, and Asian populations. Overall, MAGE-A4 prevalence based on clinical trial enrollment was 26% (447/1,750) across 10 solid tumor types, and was highest in synovial sarcoma (70%) and lowest in gastric cancer (9%). The covariates were generally not associated with MAGE-A4 expression, except for patient age in ovarian cancer and histology in non-small cell lung cancer. This report shows the eligibility rate from biomarker screening for TCR T cell therapies and provides epidemiological data for future clinical development of MAGE-A4-targeted therapies.

Afamitresgene autoleucel for advanced synovial sarcoma and myxoid round cell liposarcoma (SPEARHEAD-1): an international, open-label, phase 2 trial.

BACKGROUND: Afamitresgene autoleucel (afami-cel) showed acceptable safety and promising efficacy in a phase 1 trial (NCT03132922). The aim of this study was to further evaluate the efficacy of afami-cel for the treatment of patients with HLA-A*02 and MAGE-A4-expressing advanced synovial sarcoma or myxoid round cell liposarcoma. METHODS: SPEARHEAD-1 was an open-label, non-randomised, phase 2 trial done across 23 sites in Canada, the USA, and Europe. The trial included three cohorts, of which the main investigational cohort (cohort 1) is reported here. Cohort 1 included patients with HLA-A*02, aged 16-75 years, with metastatic or unresectable synovial sarcoma or myxoid round cell liposarcoma (confirmed by cytogenetics) expressing MAGE-A4, and who had received at least one previous line of anthracycline-containing or ifosfamide-containing chemotherapy. Patients received a single intravenous dose of afami-cel (transduced dose range 1·0 × 109-10·0 × 109 T cells) after lymphodepletion. The primary endpoint was overall response rate in cohort 1, assessed by a masked independent review committee using Response Evaluation Criteria in Solid Tumours (version 1.1) in the modified intention-to-treat population (all patients who received afami-cel). Adverse events, including those of special interest (cytokine release syndrome, prolonged cytopenia, and neurotoxicity), were monitored and are reported for the modified intention-to-treat population. This trial is registered at ClinicalTrials.gov, NCT04044768; recruitment is closed and follow-up is ongoing for cohorts 1 and 2, and recruitment is open for cohort 3. FINDINGS: Between Dec 17, 2019, and July 27, 2021, 52 patients with cytogenetically confirmed synovial sarcoma (n=44) and myxoid round cell liposarcoma (n=8) were enrolled and received afami-cel in cohort 1. Patients were heavily pre-treated (median three [IQR two to four] previous lines of systemic therapy). Median follow-up time was 32·6 months (IQR 29·4-36·1). Overall response rate was 37% (19 of 52; 95% CI 24-51) overall, 39% (17 of 44; 24-55) for patients with synovial sarcoma, and 25% (two of eight; 3-65) for patients with myxoid round cell liposarcoma. Cytokine release syndrome occurred in 37 (71%) of 52 of patients (one grade 3 event). Cytopenias were the most common grade 3 or worse adverse events (lymphopenia in 50 [96%], neutropenia 44 [85%], leukopenia 42 [81%] of 52 patients). No treatment-related deaths occurred. INTERPRETATION: Afami-cel treatment resulted in durable responses in heavily pre-treated patients with HLA-A*02 and MAGE-A4-expressing synovial sarcoma. This study shows that T-cell receptor therapy can be used to effectively target solid tumours and provides rationale to expand this approach to other solid malignancies. FUNDING: Adaptimmune.

Real-world use and perceptions of shared decision-making for allergy and asthma care in a US population.

Background: Shared decision-making (SDM), the process of engaging patients in their healthcare decisions, is an integral component of personalized medicine. The use of SDM in real-world allergy and asthma care in the United States (US) is unknown. Cross-sectional surveys of allergists and patients in a US population were conducted to assess the use and perceptions of SDM and SDM tools in real-world allergy and asthma care. Methods: Allergists (N = 101) who were members of the American College of Allergy Asthma & Immunology (ACAAI) and who were also Dynata (a marketing research firm) research partners or in the Allergy & Asthma Network customer database completed an online survey from February-March 2022. Adult patients (N = 110) with asthma, allergy, and/or eczema in the United States who were participants of online research panels hosted by Dynata completed on online survey from February 1-7, 2022. Results: Based on their own definition, 98% of the allergists reported familiarity with SDM, and 79% reported using it frequently. Allergists reported using SDM with an average of 44% of their patients. The most commonly used tool was the Immunotherapy SDM toolkit (40%); 43% had not used any SDM tool. Among allergists not using SDM or using it infrequently (n = 19), 42% considered it too time-consuming and 37% believed their patients have low health literacy. Of the surveyed patients, 25% reported their provider used SDM "frequently" or "occasionally" when being treated for allergies, asthma, or eczema, and 22% reported using SDM tools with their provider at some point. The most commonly used tool was the Asthma and Allergy Symptom Test (60%). Among patients whose allergists used SDM infrequently or never (n = 56), 70% reported they would be likely to ask their allergist to use SDM more often. Conclusion: Survey responses revealed a disconnect between allergists and patients regarding SDM use. Barriers to SDM are consistent with those across the healthcare industry. Patients clearly expressed their desire for SDM.

Perception of burden of oral and inhaled corticosteroid adverse effects on asthma-specific quality of life.

BACKGROUND: A multistakeholder core outcome set created for asthma trials showed that asthma-specific quality of life (QoL) was a critically meaningful outcome. However, the definition and measurement methods were undetermined. The adverse effects (AEs) of corticosteroids may be a vital clinical trial outcome. Nevertheless, the AE burden from the patient perspective has not yet been elucidated in an asthma population. OBJECTIVE: To characterize patient burden of AEs in oral (OCS) and inhaled corticosteroids (ICS) and how this relates to QoL within an asthma population. METHODS: We used a convergent parallel mixed-methods design with quantitative surveys of known ICS and OCS AEs that were distributed through the Allergy & Asthma Network database, social channels, and the Asthma UK newsletter. Participants rated the AEs that were (1) most burdensome and (2) most desired to be eliminated. Qualitative interviews and focus groups were performed to better understand patient views on barriers reported in the quantitative data, and to identify patient-important barriers that were not a part of the quantitative survey. RESULTS: The 3 most burdensome AEs for OCS were bone mineral density, infectious complications, and weight gain, whereas weight gain was the most desired to be eliminated. The 3 most burdensome AEs for ICS were pneumonia, hoarse voice, and oral thrush, with concordant results for the most desired to be eliminated. In the focus groups, OCS AEs were concordant with quantitative findings. Focus groups identified unmeasured psychosocial effects, such as embarrassment. CONCLUSION: The most burdensome AEs may not be those that would cause patients to stop therapy. Furthermore, qualitative focus groups suggest a psychosocial burden associated with ICS, which needs further investigation.

Patterns of care in the management of high-risk COPD in the US (2011-2019): an observational study for the CONQUEST quality improvement program.

Background: In this study, we compare management of patients with high-risk chronic obstructive pulmonary disease (COPD) in the United States to national and international guidelines and quality standards, including the COllaboratioN on QUality improvement initiative for achieving Excellence in STandards of COPD care (CONQUEST). Methods: Patients were identified from the DARTNet Practice Performance Registry and categorized into three high-risk cohorts in each year from 2011 to 2019: newly diagnosed (≤12 months after diagnosis), already diagnosed, and patients with potential undiagnosed COPD. Patients were considered high-risk if they had a history of exacerbations or likely exacerbations (respiratory consult with prescribed medication). Descriptive statistics for 2019 are reported, along with annual trends. Findings: In 2019, 10% (n = 16,610/167,197) of patients met high-risk criteria. Evidence of spirometry for diagnosis was low; in 2019, 81% (n = 1228/1523) of patients newly diagnosed at high-risk had no record of spirometry/peak expiratory flow in the 12 months pre- or post-diagnosis and 43% (n = 651/1523) had no record of COPD symptom review. Among those newly and already diagnosed at high-risk, 52% (n = 4830/9350) had no evidence of COPD medication. Interpretation: Findings suggest inconsistent adherence to evidence-based guidelines, and opportunities to improve identification, documentation of services, assessment, therapeutic intervention, and follow-up of patients with COPD. Funding: This study was conducted by the Observational and Pragmatic Research Institute (OPRI) Pte Ltd and was partially funded by Optimum Patient Care Global and AstraZeneca Ltd. No funding was received by the Observational & Pragmatic Research Institute Pte Ltd (OPRI) for its contribution.

Autologous T cell therapy for MAGE-A4+ solid cancers in HLA-A*02+ patients: a phase 1 trial.

Affinity-optimized T cell receptors can enhance the potency of adoptive T cell therapy. Afamitresgene autoleucel (afami-cel) is a human leukocyte antigen-restricted autologous T cell therapy targeting melanoma-associated antigen A4 (MAGE-A4), a cancer/testis antigen expressed at varying levels in multiple solid tumors. We conducted a multicenter, dose-escalation, phase 1 trial in patients with relapsed/refractory metastatic solid tumors expressing MAGE-A4, including synovial sarcoma (SS), ovarian cancer and head and neck cancer ( NCT03132922 ). The primary endpoint was safety, and the secondary efficacy endpoints included overall response rate (ORR) and duration of response. All patients (N = 38, nine tumor types) experienced Grade ≥3 hematologic toxicities; 55% of patients (90% Grade ≤2) experienced cytokine release syndrome. ORR (all partial response) was 24% (9/38), 7/16 (44%) for SS and 2/22 (9%) for all other cancers. Median duration of response was 25.6 weeks (95% confidence interval (CI): 12.286, not reached) and 28.1 weeks (95% CI: 12.286, not reached) overall and for SS, respectively. Exploratory analyses showed that afami-cel infiltrates tumors, has an interferon-γ-driven mechanism of action and triggers adaptive immune responses. In addition, afami-cel has an acceptable benefit-risk profile, with early and durable responses, especially in patients with metastatic SS. Although the small trial size limits conclusions that can be drawn, the results warrant further testing in larger studies.

Health Care Professionals' Herpes Zoster Awareness and Vaccine Recommendations for Patients with COPD.

Objectives: The objective of this study was to assess health care professionals' (HCPs) knowledge of an increased herpes zoster (HZ) risk and burden for patients with chronic obstructive pulmonary disease (COPD), HCPs' familiarity with the Advisory Committee on Immunization Practices' (ACIP) HZ vaccine recommendations, and the HCPs' current adult vaccine practices. Another objective was to evaluate the impact of a short educational video on knowledge and future vaccine intent. Participants and Methods: An online survey of family physicians (FPs), pulmonologists, nurse practitioners (NPs), and physician assistants (PAs) querying demographics, awareness of ACIP HZ vaccine recommendations, and HZ burdens and risks in patients with COPD and their current recommendations for HZ, influenza, and pneumococcal vaccines was conducted. For those not strongly recommending HZ vaccines concordant with ACIP recommendations, a 5-minute educational video was presented, and post video questions assessed future intended HZ vaccine recommendations. Results: Among 1020 HCP responders, awareness and ACIP concordant HZ vaccine recommendations ranged from 59.0% to 95.2% across HCPs. Lowest recommendation rates were consistently reported by pulmonologists for the 2-dose HZ vaccine beginning at age 50; for the 2-dose vaccine use in those with prior 1-dose HZ vaccinations, and for those with prior HZ. Among all HCPs, HZ vaccine recommendations were lower than for pneumococcal and influenza vaccines. After viewing the educational video, reported vaccine recommendation intent increased significantly in all groups of HCPs, as did awareness of increased HZ risk among patients with COPD. Conclusions: Significant educational opportunities exist for HCPs related to HZ and its vaccine prevention among patients with COPD which may be responsive to brief, targeted interventions.

Knowledge and Attitudes Concerning Herpes Zoster among People with COPD: An Interventional Survey Study.

Herpes zoster (HZ) is common in older adults with conditions such as chronic obstructive pulmonary disease (COPD). Effective prevention is available through vaccination, but HZ vaccine uptake remains incomplete. Using an online survey of people with self-reported COPD, ShiPPS assessed HZ risk awareness, HZ vaccine use and barriers, and the impact of an HZ educational video on vaccine intent. USA members of the COPD Foundation's Patient-Powered Research Network aged >50 years were surveyed in fall 2020. The responses were analyzed using descriptive and comparative statistics. Of the 735 respondents (59.6% female, mean age 68.5 years), 192 (26.1%) reported previous HZ, of whom 49 (25.5%) reported increased COPD symptoms during HZ episodes. Most participants (94.0%) knew of HZ vaccines, but only 33.1% reported receiving the Advisory Committee on Immunization Practices-preferred recombinant HZ vaccination. The recall of receiving HZ vaccine recommendations differed by the site attended: 68.8% primary care, 26.6% pulmonology offices. Most (74.7%) were unaware that COPD increases HZ risk. Among unvaccinated participants, interest in getting the HZ vaccine increased from 32.0% to 73.5% after watching the video. These results highlight the need for people with COPD to receive further HZ education, such as the five-minute video, and HZ vaccine recommendations from healthcare professionals.

The Role of the Pharmacist in Optimizing Outcomes With Roflumilast, a PDE4 Inhibitor for the Treatment of COPD.

PURPOSE: The pharmacology of roflumilast, recent dosing revisions, and the integral roles of pharmacists in effective chronic obstructive pulmonary disease (COPD) management are reviewed here. SUMMARY: COPD is characterized by progressive airflow limitation and intermittent acute exacerbations of symptoms, which contribute to disease progression, worsening of comorbidities, and reduced health-related quality of life. Patients with COPD may use a variety of pharmacotherapies (in combination with nonpharmacological modalities) to prevent exacerbations, reduce the impact of symptoms, and reduce or prevent COPD progression. Given the complex and multifaceted nature of disease management, pharmacists are uniquely positioned to collaborate with other clinicians to improve treatment adherence and efficacy via a number of diverse avenues in patients with COPD. Central to this endeavor is patient education and counseling regarding their treatment regimen. CONCLUSION: Recent findings from a phase 3 clinical trial demonstrate improved tolerability and reduced treatment discontinuation resulting from the use of an uptitration regimen in patients with severe COPD who initiate therapy with roflumilast. Pharmacists have a central role in effective COPD management, especially with respect to patient education about treatments.

Feedback for Learning in Pharmacy Education: A Scoping Review.

Feedback is an effective pedagogy aimed to create cognitive dissonance and reinforce learning as a key component of clinical training programs. Pharmacy learners receive constant feedback. However, there is limited understanding of how feedback is utilized in pharmacy education. This scoping review sought to summarize the breadth and depth of the use of feedback within pharmacy education and identify areas for future research. PubMed, Embase, Scopus, and Web of Science were searched for English articles since January 2000 to identify studies related to feedback in pharmacy education. Sixty-four articles were included for analysis, stratified by moderate and major theory talk, where moderate theory talk explicitly included feedback into study design and major theory talk included feedback into both study design and analysis. Feedback was provided in Bachelor (14%), Master (15.6%), Doctor of Pharmacy (67.2%) and post-graduate programs (4.7%) on a variety of curricular objectives including communication and patient work up in didactic, objective structured clinical examination (OSCE), and experiential settings, and career/interview preparation in the co-curriculum. Feedback comments were mostly written in didactic courses, and both written and verbal in OSCE, experiential, and co-curricular settings. The pharmacy education feedback literature lacks depth beyond student perceptions, especially with respect to assessing the effectiveness and quality of feedback for learning. While feedback has been utilized throughout pharmacy education across myriad outcomes, several areas for inquiry exist which can inform the design of faculty and preceptor development programs, ensuring provision of effective, quality feedback to pharmacy learners.

ARIA pharmacy 2018 "Allergic rhinitis care pathways for community pharmacy": AIRWAYS ICPs initiative (European Innovation Partnership on Active and Healthy Ageing, DG CONNECT and DG Santé) POLLAR (Impact of Air POLLution on Asthma and Rhinitis) GARD Demonstration project.

Pharmacists are trusted health care professionals. Many patients use over-the-counter (OTC) medications and are seen by pharmacists who are the initial point of contact for allergic rhinitis management in most countries. The role of pharmacists in integrated care pathways (ICPs) for allergic diseases is important. This paper builds on existing studies and provides tools intended to help pharmacists provide optimal advice/interventions/strategies to patients with rhinitis. The Allergic Rhinitis and its Impact on Asthma (ARIA)-pharmacy ICP includes a diagnostic questionnaire specifically focusing attention on key symptoms and markers of the disease, a systematic Diagnosis Guide (including differential diagnoses), and a simple flowchart with proposed treatment for rhinitis and asthma multimorbidity. Key prompts for referral within the ICP are included. The use of technology is critical to enhance the management of allergic rhinitis. However, the ARIA-pharmacy ICP should be adapted to local healthcare environments/situations as regional (national) differences exist in pharmacy care.

Experience with uncrossmatched blood refrigerator in emergency department.

BACKGROUND: Uncrossmatched packed red blood cell (PRBC) transfusion is fundamental in resuscitation of hemorrhagic shock. Ready availability of uncrossmatched blood can be achieved by storing uncrossmatched blood in a blood bank refrigerator in the emergency department (ED), but could theoretically lead to inappropriate uncrossmatched use. METHODS: This retrospective study was performed at a level I trauma center from January 2013 to March 2014. Possibly inappropriate transfusion was defined as patients who received at least one unit of blood from the ED refrigerator and no more than two units of PRBC in the first 24 hours. Deaths within the first 24 hours were excluded. Patients who received blood from the ED refrigerator who received ≤2 units total in 24 hours were compared with those who received >2 units. RESULTS: 158 adults received blood from the ED refrigerator. 140 (88.6%) were trauma patients. 37 (23.4%) received massive transfusion (MT). 42 (26.6%) deaths were excluded. 29 patients received ≤2 units and 87 received >2 units in the first 24 hours. The ≤2 units group had a higher systolic blood pressure (116 mm Hg vs. 102 mm Hg, p=0.042), lower base deficit (6.4 mEq/L vs. 9.4 mEq/L, p=0.032), higher hematocrit (34% vs. 30%, p=0.024), lower rate of MT protocol activation (27.6% vs. 58.6%, p=0.005), and lower rates of transfusion of fresh frozen plasma (17.2% vs. 54.0%, p=0.001) and platelets (13.8% vs. 39.1%, p=0.012). Appropriately transfused patients were more likely to have evidence of shock with active, non-compressible hemorrhage. Potentially inappropriate uses were more likely in patients either without evidence of hemorrhage or without signs of shock. DISCUSSION: Storing uncrossmatched blood in the ED is an effective way to get PRBCs transfused quickly in hemorrhaging patients and is associated with a low rate of unnecessary uncrossmatched transfusion. Provider education and good clinical judgment are imperative to prevent unnecessary use. LEVEL OF EVIDENCE: Level III, therapeutic.

Antimicrobial stewardship education in US colleges and schools of pharmacy.

Background: Pharmacists are key members of antimicrobial stewardship (AS) teams. It is unknown if and how US colleges and schools of pharmacy incorporate AS into their Doctor of Pharmacy (PharmD) curricula. Methods: This study was a cross-sectional, multicentre, electronic survey distributed to infectious diseases faculty or department chairs of 137 accredited and candidate-status PharmD programmes. Results: One hundred and sixteen programmes participated, representing an 84.7% response rate. AS education was integrated into the required didactic, elective didactic and experiential education components of the curricula in 79 (68.1%), 43 (37.1%) and 97 (83.6%) PharmD programmes, respectively. The most common AS topics in required and elective didactic curricula were AS definitions, principles and purpose (98.7% and 86.0%) and the pharmacist's role in AS (93.7% and 83.7%). In the required and elective didactic curricula, lecture (93.7% and 86.0%) and case-based instruction (57.0% and 83.7%) were the most common instructional methods. For experiential education, the pharmacist's role in AS (96.9%), de-escalation of antimicrobials (96.9%) and antimicrobial dose optimization (95.9%) were the most common AS topics. PharmD programmes employing a faculty member who specializes in AS were more likely to offer AS experiential education than programmes without AS faculty (88.1% versus 71.9%, P = 0.049). Conclusions: Integration of AS education in US PharmD curricula is variable and there are considerable differences in the AS activities and topics delivered. PharmD programmes should attempt to expose students to AS education to prepare future pharmacists for AS practice. Efforts should be made to incorporate interprofessional collaboration into AS education.

Clinical Pharmacology of Bronchodilator Medications.

Obstructive lung diseases, including asthma and COPD, are characterized by air-flow limitation. Bronchodilator therapy can often decrease symptoms of air-flow obstruction by relaxing airway smooth muscle (bronchodilation), decreasing dyspnea, and improving quality of life. In this review, we discuss the pharmacology of the ß agonist and anticholinergic bronchodilators and their use, particularly in asthma and COPD. Expanding knowledge of receptor subtypes and G-protein signaling, agonist and antagonist specificity, and drug delivery have led to the introduction of safer medications with fewer off-target effects, medications with longer duration of action that may improve adherence, and more effective and efficient aerosol delivery devices.

Clinical Pharmacology of Corticosteroids.

Corticosteroids have numerous applications in treating inflammation and diseases of immune function based on their significant anti-inflammatory and immunosuppressive effects. Corticosteroids modulate immune function through various effects in the nucleus of numerous cells. When used in pharmacologic doses to suppress allergic responses or inflammation, these agents can cause numerous adverse effects associated with an excess of glucocorticoid activity. Prolonged use (>2 wk) results in suppression of the hypothalamic-pituitary-adrenal axis, which requires tapering of doses. Dosing strategies for systemic corticosteroids are designed to minimize the risk for hypothalamic-pituitary-adrenal axis suppression. Topical administration of corticosteroids, including oral inhalation, is often used to avoid the significant adverse effects associated with chronic use. Inhaled corticosteroids are potent synthetic agents that exert their actions locally in the airways but can cause systemic effects based on several factors that influence systemic bioavailability. Inhaled corticosteroids are the cornerstone of asthma therapy and important options for COPD in patients who experience frequent exacerbations. By the nasal route, they are the most effective therapy for treating moderate-to-severe allergic rhinitis.

Evaluation of a field-deployable reverse transcription-insulated isothermal PCR for rapid and sensitive on-site detection of Zika virus.

BACKGROUND: The recent emergence of Zika virus (ZIKV) in Brazil and its precipitous expansion throughout the Americas has highlighted the urgent need for a rapid and reliable on-site diagnostic assay suitable for viral detection. Such point-of-need (PON), low-cost diagnostics are essential for ZIKV control in vulnerable areas with limited resources. METHODS: We developed and evaluated a ZIKV-specific field-deployable RT-iiPCR reagent set targeting the E gene for rapid detection of ZIKV in ZIKV-spiked human and mosquito specimens, and compared its performance to the Center for Disease Control and Prevention (CDC) and Pan American Health Organization (PAHO) RT-qPCR assays targeting the E and NS2B genes, respectively. RESULTS: These assays demonstrated exclusive specificity for ZIKV (African and Asian lineages), had limits of detection ranging from 10 to 100 in vitro transcribed RNA copies/µl and detection endpoints at 10 plaque forming units/ml of infectious tissue culture fluid. Analysis of human whole blood, plasma, serum, semen, urine, and mosquito pool samples spiked with ZIKV showed an agreement of 90% (k = 0.80), 92% (k = 0.82), 95% (k = 0.86), 92% (k = 0.81), 90% (k = 0.79), and 100% (k = 1), respectively, between the RT-iiPCR assay and composite results from the reference RT-qPCR assays. Overall, the concurrence between the ZIKV RT-iiPCR and the reference RT-qPCR assays was 92% (k = 0.83). CONCLUSIONS: The ZIKV RT-iiPCR has a performance comparable to the reference CDC and PAHO RT-qPCR assays but provides much faster results (~1.5 h) with a field-deployable system that can be utilized as a PON diagnostic with the potential to significantly improve the quality of the health care system in vulnerable areas.