Point-of-Care Testing in Primary Care

Point-of-care testing (POCT) in pediatric primary care is essential for clinicians to make a timely and accurate diagnosis. The COVID-19 pandemic has highlighted the importance of timely and accurate testing strategies to correctly identify the etiology of upper and lower respiratory infections. Additionally, pediatric POCT continues to be important in rural and underserved communities where access to hospital laboratories may be less available. This chapter will focus on seven rapid tests: Group A streptococcus (GAS), influenza A & B, SARS-CoV-2 (COVID-19), human immunodeficiency virus (HIV), C-reactive protein (CRP), human chorionic gonadotropin (hCG), and hemoglobin A1c (HbA1c). © The Editor(s) (if applicable) and The Author(s), under exclusive license to Springer Nature Switzerland AG 2022.

Classification of "Near-patient" and "Point-of-Care" SARS-CoV-2 Nucleic Acid Amplification Test Systems and a first approach to evaluate their analytical independence of operator activities.

BACKGROUND: European legislation defines as "near-patient testing" (NPT) what is popularly and in other legislations specified as "point-of-care testing" (POCT). Systems intended for NPT/POCT use must be characterized by independence from operator activities during the analytic procedure. However, tools for evaluating this are lacking. We hypothesized that the variability of measurement results obtained from identical samples with a larger number of identical devices by different operators, expressed as the method-specific reproducibility of measurement results reported in External Quality Assessment (EQA) schemes, is an indicator for this characteristic. MATERIALS AND METHODS: Legal frameworks in the EU, the USA and Australia were evaluated about their requirements for NPT/POCT. EQA reproducibility of seven SARS-CoV-2-NAAT systems, all but one designated as "POCT", was calculated from variabilities in Ct values obtained from the respective device types in three different EQA schemes for virus genome detection. RESULTS: A matrix for characterizing test systems based on their technical complexity and the required operator competence was derived from requirements of the European In Vitro Diagnostic Regulation (IVDR) 2017/746. Good EQA reproducibility of the measurement results of the test systems investigated implies that different users in different locations have no recognizable influence on their measurement results. CONCLUSION: The fundamental suitability of test systems for NPT/POCT use according to IVDR can be easily verified using the evaluation matrix presented. EQA reproducibility is a specific characteristic indicating independence from operator activities of NPT/POCT assays. EQA reproducibility of other systems than those investigated here remains to be determined.

Efficiency analysis of rapid antigen test based SARS-CoV-2 in hospital contact tracing and screening regime: test characteristics and cost effectiveness.

In the context of the current SARS-CoV-2 pandemic, reliable and cost-efficient screening and testing strategies are crucial to prevent disease transmission and reduce socioeconomic losses. To assess the efficiency of a rapid antigen test (RAT)-based SARS-CoV-2 contact-tracing and screening regime, we conducted a retrospective analysis of RAT and polymerase chain reaction (PCR) test data over a 1-year period, assessed test characteristics and estimated cost-effectiveness. The RAT had a sensitivity of 70.2% overall and 89.3% for people with a high risk of infectivity. We estimated inpatient treatment and quarantined healthcare worker costs of over € 5860.83, whereas the cost of identifying one SARS-CoV-2 positive person by RAT for our patient cohort was € 1210.75. In contrast, the estimated respective PCR cost was € 5043.32. Therefore, a RAT-based contract tracing and screening regime may be an efficient and cost-effective way to contribute to the early identification and prevention of SARS-CoV-2 transmission.

Point-of-care testing of SARS -CoV-2 and influenza A and B at hospital emergency room during Covid-19 pandemic among patients with acute respiratory diseases

Introduction. The most common causes of acute respiratory diseases (ARD) with significant morbidity and mortality include, for a long time, the influenza virus and, in recent years, also the SARS-Cov-2 virus. Patients with various clinical symptoms are triaged in emergency rooms of hospitals, and therefore their rapid and reliable diagnostics is essential in order to prevent the spread of ARD. Molecular genetic point-of-care testing (POCT) at the point of care represents a significant advance in clinical diagnostics. Materials and methods. Diagnostics of viral agents of ARD took place from December 2021 to February 2022. 1046 nasopharynx swabs samples were collected in the emergency room of I. Internal Clinic of the Faculty of Medicine at Comenius University and the University Hospital in Bratislava. SARSCov-2 and influenza were detected from the same sample using the cobas® SARS-Cov-2 & Influenza A/B test on the cobas® Liat® system. Results. From the total number of biological material collected, the SARS-Cov-2 virus was detected in 135 samples (12.9 %), while the highest incidence of positive samples was in February 2022 - 86 (20.9 % positivity), followed by December 2021 - 31 (23.0 % positivity) and January 2022 - 18 (13.3% positivity). Influenza type A virus was detected in two samples (0.2%) and influenza type B virus was not detected. Conclusion. POCT made it possible to significantly improve the screening of patients and minimize the risk of nosocomial transmission of respiratory infections in the hospital thanks to the rapid and accurate diagnosis of the SARS-CoV-2 virus and influenza A/B (Fig. 3, Ref. 32). Text v PDF www.lekarsky.herba. sk. © 2023, Lekarsky Obzor. All Rights Reserved.

Community pharmacist-provided test and treat programs for acute infectious conditions

Community pharmacists' roles have expanded in recent years to include offering test and treat programs where they perform testing on Clinical Laboratory Improvement Amendment (CLIA)-waived point-of-care testing (POCT) devices to diagnose specific acute infectious conditions, such as influenza and group A streptococcus (GAS) pharyngitis, and then potentially prescribe and dispense appropriate antimicrobials. Availability of these services in pharmacies has several benefits, including increased access to care, decreased overutilization of other health care services, and decreased antimicrobial resistance. States have different requirements for collaborative practice agreements and reimbursement for these clinical services in community pharmacies. Several studies have looked at outcomes related to community pharmacies implementing test and treat programs for influenza and/or GAS. Other studies looked at outcomes related to implementing testing for SARS-CoV-2 and referring for treatment. Most studies described successful implementation and barriers to integration of these programs into pharmacy workflow. Some studies showed that patients want these services to be offered in community pharmacies and are willing to pay for the services. Data show that these services are cost effective compared to physician provider-based treatment. Newer CLIA-waived POCT technology may increase implementation of these services, but studies are needed to evaluate their utility in community pharmacies. Pharmacy schools should implement widespread training on these devices, and research should continue in this area to test the use of newer technology (i.e., multiplexed devices) and their economic impact.Copyright © 2023 Pharmacotherapy Publications, Inc.

CoLAMP: CRISPR-based one-pot loop-mediated isothermal amplification enables at-home diagnosis of SARS-CoV-2 RNA with nearly eliminated contamination utilizing amplicons depletion strategy.

Rapid point-of-care diagnostics, essential in settings such as airport on-site testing and home-based screening, displayed important implications for infectious disease control during the SARS-CoV-2 outbreak. However, the deployment of simple and sensitive assays in real-life scenarios still faces the concern of aerosol contamination. Here, we report an amplicon-depleting CRISPR-based one-pot loop-mediated isothermal amplification (CoLAMP) assay for point-of-care diagnosis of SARS-CoV-2 RNA. In this work, AapCas12b sgRNA is designed to recognize the activator sequence sited in the loop region of the LAMP product, which is crucial for exponential amplification. By destroying the aerosol-prone amplifiable products at the end of each amplification reaction, our design can significantly reduce the amplicons contamination that causes false positive results in point-of-care diagnostics. For at-home self-testing, we designed a low-cost sample-to-result device for fluorescence-based visual interpretation. As well, a commercial portable electrochemical platform was deployed as a proof-of-concept of ready-to-use point-of-care diagnostic systems. The field deployable CoLAMP assay can detect as low as 0.5 copies/µL of SARS-CoV-2 RNA in clinical nasopharyngeal swab samples within 40 min without the need for specialists for its operation.

Characteristics of the ID-NOW™ test for the rapid detection of SARS-CoV-2.

OBJECTIVE: To determine the sensitivity and specificity of the Abbott ID-NOW™ test in the diagnosis of COVID-19. The test is based on the detection of the SARS-CoV-2 gene by isothermal amplification technology. METHODS: From 303 individuals, two nasopharyngeal swabs and one oropharyngeal swab were collected to be tested in parallel by the ID-NOW™ test and PCR test (Allplex™ SARS-CoV-2 Assay). A subgroup of 107 individuals presented to the public collection point for covid-19 at the Motol University Hospital during the dominance of the Delta variant, and the others were tested via the Adult Emergency Admission Department during the dominance of the Omicron variant. RESULTS: Of 297 valid samples, 43 were positive by the PCR assay and 33 were positive by the ID-NOW™ test (sensitivity 76.74%; 95% CI 61.37 to 88.24%). ID-NOW™ detected three samples as positive, but the positivity was not confirmed by PCR (specificity 98.82%; 95% CI 96.59 to 99.76%). A significant increase in sensitivity up to 100% is observed for samples with a higher viral load (with a PCR threshold cycle value below 30 or from patients with symptoms of COVID-19). The Delta or Omicron variant has no significant effect on the sensitivity of the test. CONCLUSION: Due to its ease of use and speed of result, ID-NOW™ is a suitable diagnostic tool for prompt assessment of a patient's infectivity. If, despite the negative ID-NOW™ result, the patient has symptoms of COVID-19, it is advised to perform a classic PCR test for SARS-CoV-2.

Multiplex and Ultrasensitive Detection of Severe Acute Respiratory Syndrome Coronavirus 2 and Influenza A/B Nucleocapsid Proteins Based on Nanometer-Sized Core-Shell Superparamagnetic Antifouling Probes

Infections caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza A (Flu A), and influenza B (Flu B) show similar clinical symptoms, such as cough, fever, and dyspnea, but patients infected by these viruses should be treated differently. The rapid and accurate diagnosis of infections caused by SARS-CoV-2, Flu A or Flu B is critical during the influenza season. Herein, we synthesized core-shell magnetic particles (MNPs) with excellent antifouling properties and applied them in the MNP-based immunochromatographic test (MICT) for simultaneous detection of SARS-CoV-2, Flu A, and Flu B nucleocapsid(N) proteins in 20 min. Two kinds of carboxyl -modified MNPs, MNP@pMBAA and MNP@Si-SA, were prepared and evaluated as probes in the MICT. Among them, the MNP@ pMBAA showed lower nonspecific adsorption of proteins and low background noise in the application in MICTs. Particularly, the MNP@pMBAA50 bead-based MICT strip exhibited the highest signal-to-noise ratio for SARS-CoV-2 N protein detection with a limit of detection (LOD) of 0.072 ng/mL. Moreover, the proposed MICT strip demonstrated a minimal cross-reactivity and a broad linear dynamic detection range under a magnetic assay reader in the simultaneous detection of SARS-CoV-2, Flu A, and Flu B N proteins with relative LOD values of 0.0086, 0.012, and 0.018 ng/mL, respectively. The results demonstrated that the synthesized MNPs showed great potential for use as MICT probes for sensitive and multiplex detection of biomarkers in the development of point-of-care testing systems.

Enhanced electrochemiluminescence immunoassay: 2. Enabling signal detection at an early stage of incubation for rapid point-of-care testing

Signal detection in a label-based immunoassay is performed normally when the antigen/antibody binding reaction reaches the equilibrium state during the incubation period of an assay process. Shortening the incubation period in an assay helps reduce the turnaround time and is particularly valuable for point-of-care testing, but the cost is the reduction of signal level and, possibly, measurement precision as well. This work demonstrates that the signal loss could be offset by the stronger emission of an electronically neutral ruthenium(II) complex label, Ru(2, 2′-bipyridine) (bathophenanthroline disulfonate)[4-(2, 2′-bipyridin-4-yl)butanoic acid], used in the electrochemiluminescence (ECL) immunoassay. Combined with the uniquely well-established flow-through washing process in the automated ECL analyzers and the precise control over liquid handling, the assays performed with a 5-minute incubation period showed the same signal level and measurement precision as those of conventional ECL assays. Additionally, the absence of biotin and streptavidin components in the reagent formulation avoids the biotin-streptavidin interaction during assay incubation and fundamentally eliminates the interference of biotin, especially when used in some high-dose therapies. The results obtained from the procalcitonin prototype kit and the supporting evidence from other preliminary reagents (for SARS-CoV-2 N protein and troponin T) are general. The nonequilibrium detection, along with the downsized instrument design, makes the enhanced ECL (EECL) technology a fast high-performance POCT platform that provides the same high-quality data as those generated from the widely deployed [Ru(bpy)3]2+ based laboratorial ECL systems. The anticipated regulatory approval and follow-up clinical implementation will be a significant stride in the decade-long pursuit of novel ECL labels. © 2023 The Author(s)

CRISPR-based assays for rapid detection of SARS-CoV-2

The coronavirus disease 2019 (COVID-19) pandemic caused unparalleled global threat in terms of public health and economic loss. To date, there is no effective way of treating this disease, and the only way to control this disease is the extensive diagnosis of COVID-19 symptomatic patients and isolate them from the healthy population and treat them with appropriate medicine. There is a requirement of a global standard diagnosis method to quickly control this pandemic disease, which should be specific, easy to use, and inexpensive and requires least instrumentation at point-of-care testing (POCT). Serology-based tests are popular, inexpensive, and easy to use to diagnose COVID-19 patients, but they lack sensitivity at lower inoculum concentrations and may indicate false negatives which possess a major threat in spreading this pandemic disease. To avoid this issue, nucleic acid-based tests are more specific and sensitive to diagnose COVID-19 patients. However, it has some limitations such as a low sample throughput, expensive reagents, an extensive time, and requirement of costly quantitative reverse transcription–polymerase chain reaction instruments. To overcome this limitation, the latest CRISPR-based detection methods coupled with allied isothermal nucleic acid amplification methods such as loop-mediated isothermal amplification would provide inexpensive, quick, accurate, and easy ways of diagnosing a large number of populations at POCT. Here, we discuss some of the promising CRISPR-based assays which have the potential to transform COVID-19 diagnosis globally and curb this pandemic disease in the shortest possible time. © 2023 Elsevier Inc. All rights reserved.

Multiplex and Ultrasensitive Detection of Severe Acute Respiratory Syndrome Coronavirus 2 and Influenza A/B Nucleocapsid Proteins Based on Nanometer-Sized Core-Shell Superparamagnetic Antifouling Probes

Infections caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza A (Flu A), and influenza B (Flu B) show similar clinical symptoms, such as cough, fever, and dyspnea, but patients infected by these viruses should be treated differently. The rapid and accurate diagnosis of infections caused by SARS-CoV-2, Flu A or Flu B is critical during the influenza season. Herein, we synthesized core-shell magnetic particles (MNPs) with excellent antifouling properties and applied them in the MNP-based immunochromatographic test (MICT) for simultaneous detection of SARS-CoV-2, Flu A, and Flu B nucleocapsid(N) proteins in 20 min. Two kinds of carboxyl-modified MNPs, MNP@pMBAA and MNP@Si-SA, were prepared and evaluated as probes in the MICT. Among them, the MNP@pMBAA showed lower nonspecific adsorption of proteins and low background noise in the application in MICTs. Particularly, the MNP@pMBAA50 bead-based MICT strip exhibited the highest signal-to-noise ratio for SARS-CoV-2 N protein detection with a limit of detection (LOD) of 0.072 ng/mL. Moreover, the proposed MICT strip demonstrated a minimal cross-reactivity and a broad linear dynamic detection range under a magnetic assay reader in the simultaneous detection of SARS-CoV-2, Flu A, and Flu B N proteins with relative LOD values of 0.0086, 0.012, and 0.018 ng/mL, respectively. The results demonstrated that the synthesized MNPs showed great potential for use as MICT probes for sensitive and multiplex detection of biomarkers in the development of point-of-care testing systems. © 2023 American Chemical Society.

Self-powered digital microfluidics driven by rotational triboelectric nanogenerator

Digital microfluidic (DMF) has emerged as one of the most popular microfluidic platforms for sample-preparation in biochemical analysis and lab-on-a-chip applications. Operated with electrowetting on dielectric (EWOD) mechanism, DMF conventionally requires an external power source to provide the actuation voltage, which limited its portability and broader applications in point-of-care testing (POCT) environment. Herein, a DMF device, self-powered by triboelectric nanogenerator (TENG) is presented. TENG possesses a number of unique characteristics, and is very attractive to be integrated with DMF. It only requires a simple configuration with low-cost fabrication that can improve the DMF portability, but it also provides high voltage, low current output characteristics that are consistent with the EWOD actuation requirements. Basic droplet manipulations, including transportation, split, merge, dispense, and even elongate to follow the electrode patterns of alphabets, on a DMF device powered with manually-rotated Disk-TENG are demonstrated for the first time. Further, droplets containing samples and reagents are transported and mixed on the programmed electrode patterns on the chip to conduct chemical reactions, including nucleic acid amplification and phenol red test, showing that Disk-TENG can serve as the power source for DMF chips in POCT applications. © 2023 Elsevier Ltd

Hand-powered centrifugal micropipette-tip with distance-based quantification for on-site testing of SARS-CoV-2 virus.

This paper proposed a hand-powered centrifugal micropipette-tip strategy, termed HCM, for all-in-one immunoassay combined with a distance-based readout for portable quantitative detection of SARS-CoV-2. The target SARS-CoV-2 virus antigen triggers the binding of multiple monoclonal antibody-coated red latex nanobeads, forming larger complexes. Following incubation and centrifugation, the formed aggregated complexes settle at the bottom of the tip, while free red nanobeads remain suspended in the solution. The HCM enables sensitive (1 ng/mL) and reliable quantification of SARS-CoV-2 within 25 min. With the advantages of free washing, free fabrication, free instrument, and without the optical device, the proposed low-cost and easy-to-use HCM immunoassay shows great potential for quantitative POC diagnostics for SARS-CoV-2.

Evaluation of the ID NOW among symptomatic individuals during the Omicron wave.

Introduction. Starting in December, 2020, the ID NOW was implemented throughout the province of Alberta, Canada (population 4.4 million) in various settings.Gap statement. ID NOW's test performance with SARS-CoV-2 Omicron variant BA.1 is unknown.Aim. To assess the ID NOW performance among symptomatic individuals during the BA.1 Omicron wave and compare it to previous SARS-CoV-2 variant waves.Methodology. The ID NOW was assessed in two locations among symptomatic individuals: rural hospitals and community assessment centres (AC) during the period 5-18 January 2022. Starting 5 January, Omicron represented >95 % of variants detected in our population. For every individual tested, two swabs were collected: one for ID NOW testing and the other for either reverse-transcriptase polymerase chain reaction (RT-PCR) confirmation of negative ID NOW results or for variant testing of positive ID NOW results.Results. A total of 3041 paired samples were analysed (1139 RT-PCR positive). From this, 1873 samples were from 42 COVID-19 AC and 1168 from 69 rural hospitals. ID NOW sensitivity for symptomatic individuals presenting to community AC and rural hospitals was 96.0 % [95 % confidence interval (CI) 94.5-97.3 %, n=830 RT-PCR positive], and 91.6 % (95 % CI 87.9-94.4 %, n=309 RT-PCR positive), respectively. SARS-CoV-2 positivity rate was very high for both populations (44.3 % at AC, 26.5 % in hospital).Conclusions. Sensitivity of ID NOW SARS-CoV-2, compared to RT-PCR, is very high during the BA.1 Omicron wave, and is significantly higher when compared to previous SARS-CoV-2 variant waves.

[CRISPR-based molecular diagnostics: a review].

Rapid and accurate detection technologies are crucial for disease prevention and control. In particular, the COVID-19 pandemic has posed a great threat to our society, highlighting the importance of rapid and highly sensitive detection techniques. In recent years, CRISPR/Cas-based gene editing technique has brought revolutionary advances in biotechnology. Due to its fast, accurate, sensitive, and cost-effective characteristics, the CRISPR-based nucleic acid detection technology is revolutionizing molecular diagnosis. CRISPR-based diagnostics has been applied in many fields, such as detection of infectious diseases, genetic diseases, cancer mutation, and food safety. This review summarized the advances in CRISPR-based nucleic acid detection systems and its applications. Perspectives on intelligent diagnostics with CRISPR-based nucleic acid detection and artificial intelligence were also provided.

An IoT-based smart optical platform for colorimetric analyzing multiple samples of biomarkers

In this work, we have designed, implemented, and characterized an IoT-enabled optical platform that serves as a highly efficient colorimetric analyzer for disposable rapid diagnostic test kits. We have taken color images of the test chip using an external camera module connected to an IoT-enabled single-board mini-computer, which are then analyzed using an image processing algorithm. To prevent image burning and to reduce the impact of ambient lighting, we have proposed a unique light-diffusing model and have maintained a strategic distance within the white acrylic imaging enclosure of the platform. In order to ensure even and uniform distribution of light on the sample within the platform, we have carried out a study with the incorporation of a highly bright single LED, an LED array, and attaching a PDMS-made light diffuser on the LED array at varying light incident angles on custom-made single-channel test kits containing blood hematocrit. Finally, based on the optimized lighting conditions, we have successfully applied the proposed platform for the detection of blood hematocrit, β-hCG, and SARS-CoV-2 antigen, and were able to identify their different levels of concentration. Since the device is portable in size and cost-effective to implement, it can also be used for analyzing other biomarkers in resource-limited communities for point-of-care (POC) applications.

Single-Center Experience in Detecting Influenza Virus, RSV and SARS-CoV-2 at the Emergency Department.

Reverse transcription polymerase chain reaction (RT-PCR) on respiratory tract swabs has become the gold standard for sensitive and specific detection of influenza virus, respiratory syncytial virus (RSV) and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). In this retrospective analysis, we report on the successive implementation and routine use of multiplex RT-PCR testing for patients admitted to the Internal Medicine Emergency Department (ED) at a tertiary care center in Western Austria, one of the hotspots in the early coronavirus disease 2019 (COVID-19) pandemic in Europe. Our description focuses on the use of the Cepheid® Xpert® Xpress closed RT-PCR system in point-of-care testing (POCT). Our indications for RT-PCR testing changed during the observation period: From the cold season 2016/2017 until the cold season 2019/2020, we used RT-PCR to diagnose influenza or RSV infection in patients with fever and/or respiratory symptoms. Starting in March 2020, we used the RT-PCR for SARS-CoV-2 and a multiplex version for the combined detection of all these three respiratory viruses to also screen subjects who did not present with symptoms of infection but needed in-hospital medical treatment for other reasons. Expectedly, the switch to a more liberal RT-PCR test strategy resulted in a substantial increase in the number of tests. Nevertheless, we observed an immediate decline in influenza virus and RSV detections in early 2020 that coincided with public SARS-CoV-2 containment measures. In contrast, the extensive use of the combined RT-PCR test enabled us to monitor the re-emergence of influenza and RSV detections, including asymptomatic cases, at the end of 2022 when COVID-19 containment measures were no longer in place. Our analysis of PCR results for respiratory viruses from a real-life setting at an ED provides valuable information on the epidemiology of those infections over several years, their contribution to morbidity and need for hospital admission, the risk for nosocomial introduction of such infection into hospitals from asymptomatic carriers, and guidance as to how general precautions and prophylactic strategies affect the dynamics of those infections.

Prospective population-level validation of the Abbott ID NOW severe acute respiratory syndrome coronavirus 2 device implemented in multiple settings for testing asymptomatic and symptomatic individuals.

OBJECTIVE: Diagnostic evaluation of the ID NOW coronavirus disease 2019 (COVID-19) assay in various real-world settings among symptomatic and asymptomatic individuals. METHODS: Depending on the setting, the ID NOW testing was performed using oropharyngeal swabs (OPSs) taken from patients with symptoms suggestive of COVID-19, asymptomatic close contacts, or asymptomatic individuals as part of outbreak point prevalence screening. From January to April 2021, a select number of sites switched from using OPS to combined oropharyngeal and nasal swab (O + NS) for ID NOW testing. For every individual tested, two swabs were collected by a health care worker: one swab (OPS or O + NS) for ID NOW testing and a separate swab (OPS or nasopharyngeal swab) for RT-PCR. RESULTS: A total of 129 112 paired samples were analysed (16 061 RT-PCR positive). Of these, 81 697 samples were from 42 COVID-19 community collection sites, 16 924 samples were from 69 rural hospitals, 1927 samples were from nine emergency shelters and addiction treatment facilities, 23 802 samples were from six mobile units that responded to 356 community outbreaks, and 4762 O + NS swabs were collected from three community collection sites and one emergency shelter. The ID NOW assay sensitivity was the highest among symptomatic individuals presenting to community collection sites (92.5%; 95% CI, 92.0-93.0%) and the lowest for asymptomatic individuals associated with community outbreaks (73.9%; 95% CI, 69.8-77.7%). Specificity was >99% in all populations tested. DISCUSSION: The sensitivity of ID NOW severe acute respiratory syndrome coronavirus 2 testing is the highest when used in symptomatic community populations not seeking medical care. Sensitivity and positive predictive value drop by approximately 10% when tested on asymptomatic populations. Using combined oropharyngeal and nasal swabs did not improve the performance of ID NOW assay.

CRISPR-based point-of-care plant disease diagnostics.

The coupling of clustered regularly interspaced short palindromic repeats (CRISPR)-Cas RNA-programmable nucleases with nucleic acid detection platforms has brought radical changes to the field of disease diagnosis. Recently, Sánchez et al. developed a simple, rapid, highly sensitive, precise, and in-field deployable point-of-care (POC) and point-of-need (PON) molecular disease detection tool that can be used in diverse agricultural applications.

Rapid identification of SARS-CoV-2 in the point-of-care using digital PCR-based Dr. PCR™ Di20K COVID-19 Detection Kit without viral RNA extraction.

BACKGROUND: Since COVID-19 was declared the pandemic by the WHO, it has continued to spread. There is a need for rapid, efficient, and accurate diagnostic kits and techniques to control its spread. OBJECTIVE: The diagnostic capability of the qRT-PCR-based Real-Q 2019-nCoV Detection Kit and dPCR-based Dr. PCR™ Di20K COVID-19 Detection Kit was compared and evaluated. METHODS: Diagnostic tests for COVID-19 were performed using two different COVID-19 kits and 301 individual specimens with confirmed COVID-19 positive/negative at the government-accredited medical institution. Assessment of diagnostic capability was measured through diagnostic sensitivity, specificity, Cohen's Kappa coefficient, and dilutional linearity tests. RESULTS: The COVID-19 diagnostic test results using two kits and 301 individual specimens perfectly matched the pre-diagnosis results of the medical institution. In addition, the measurement results of diagnostic sensitivity and specificity were "1", indicating high diagnostic capability. Cohen's Kappa coefficient value is "1", which means that the diagnosis concordance between the two kits is "Almost Perfect". As a result of dilutional linearity tests to evaluate their detection capability, both kits were measured with very high detection reliability. CONCLUSION: Here, we propose that the dPCR-based Dr. PCR™ Di20K COVID-19 Detection Kit has the advantages of the dPCR method reported in the previous study and is suitable for point-of-care testing (POCT) by overcoming the limitations of space, test time, cross-over contamination, and biosafety due to omitting RNA extraction process.