Acute myocardial infarction and coronavirus infection (COVID-19).

The aim of the study is to describe a case of COVID-19 and myocardial infarction in an elderly patient. Material and methods. The analysis of medical documentation (outpatient card of the patient, medical history, postmortem report) was carried out. Studied macro- and micropreparations (staining with hematoxylin and eosin). Results. A 67-year-old patient, from 23.04.2020 to 26.04.2020, was hospitalized with a diagnosis of suspected coronavirus infection (COVID-19). On the background of the treatment, the patient's biological death occurred (26.04.2020). The sectional study revealed signs of bilateral total hemorrhagic pneumonia. The signs of acute transmural myocardial infarction of the anterior wall of the left ventricle were determined. Posthumously, SARS-CoV-2 RNA was detected in the lung tissue by nucleic acid amplification. In the described clinical case, a patient with concomitant cardiovascular diseases, such as arterial hypertension, coronary heart disease, developed complications against the background of COVID-19: hemorrhagic pneumonia and myocardial infarction with a fatal outcome.Copyright © Infectious Diseases: News, Opinions, Training.

Diagnostic value of sputum nucleic acid amplification testing for COVID-19 a meta-analysis

Objective: To systematically evaluate the diagnostic value of nucleic acid test in sputum for COVID-19 and to determine the suitable population for sputum specimens. Method(s): PubMed, CNKI, Scopus, Web of Science, medRxiv and bioRxiv databases were searched for the diagnostic value of sputum nucleic acid test for COVID-19 from December 2019 to April 2022. Two researchers independently screened the literature, extracted data, and evaluated the risk of bias with QUADAS-2 in the included studies. We used sensitivity, specificity, AUC and DOR to evaluate the diagnostic value of sputum specimens. Result(s): A total of 25 studies were included, including 10,731 subjects. Meta-analysis results showed that: The combined sensitivity (SEN), specificity (SPE), diagnostic odds ratio (DOR), and area under operating characteristic curve (AUC) of sputum nucleic acid for the diagnosis of COVID-19 were 89.2% (95% CI, 86.6-91.4), 97.5% (95% CI, 97.2-97.8), 41.4 (95% CI, 11.7-145.9), 0.9474 (95% CI, 0.8964-0.9846). The results of subgroup analysis showed that the Asian group's DOR was 36.835 (95% CI, 10.83-134.570), and the Non-Asian group's DOR was 66.294 (95% CI, 0.719-6109.09). The DOR was 27.207 (95% CI, 2.860-258.780) in the OPS group and 44.165 (95% CI, 4.828-403.970) in the NPS group. DOR of mild patients was 84.255 (95% CI, 9.975-711.690), the DOR of the severe group was 14.216 (95% CI, 3.527-57.142) and was 19.464 (95% CI, 0.724-522.920) in the cured group. Conclusion(s): Current evidence shows that sputum nucleic acid test is of high diagnostic value for COVID-19. Study area and severity of disease are the influencing factors for the diagnostic accuracy of the sputum nucleic acid test. Due to the limitations on the number and quality of the included studies, the above conclusions need to be verified by more high-quality studies.Copyright © 2023, E-Century Publishing Corporation. All rights reserved.

REACTOGENICITY AMONG PEOPLE LIVING WITH HIV AFTER mRNA-1273 VACCINE IN UBUNTU STUDY

Background: The tolerability of mRNA COVID-19 vaccines among people living with HIV (PLWH) has been understudied in vaccine trials. CoVPN 3008 (Ubuntu) is the largest multicenter Phase 3 efficacy trial of mRNA vaccines in sub-Saharan Africa. Method(s): We enrolled adults age >=18 years living with HIV or another comorbidity associated with severe COVID-19. Previously vaccinated individuals were excluded. Baseline testing included HIV, CD4 count and HIV viral load (VL) (if HIV+), anti-SARS-CoV-2 antibodies, and nasal swab SARS-CoV-2 nucleic acid amplification test (NAAT). All participants receive vaccinations at months 0 and 6, and SARS-CoV-2 seronegative individuals also receive vaccination at month 1. This analysis includes mRNA-1273 vaccinations at months 0 and 1. Reactogenicity (solicited adverse events [AEs]) was assessed among a representative subset of participants (Safety Subset, SS) for 7 days post-vaccination. Baseline characteristics associated with moderate/severe reactogenicity events were assessed by univariate and multivariate logistic regression. Result(s): 14002 participants were enrolled in the trial (1510 into the SS) at 46 sites from 2 Dec 2021 to 9 Sep 2022. At baseline in the SS, 71% (1065) were female, median age 38 years (IQR 32-46), and median BMI 25.0 (IQR 20.7-30.2). 73% (1108) were SARS-CoV-2 seropositive, and 8.7% (131) had a positive nasal NAAT swab. 16% (197) had a history of tuberculosis. 84% (1267) were PLWH, with median CD4 count of 614 cells/muL (IQR 414-861);7.8% had CD4 count < 200. 21% (238) had detectable HIV VL (>=50 copies/mL), with median VL 1660 (IQR 182-23932). 14% (172/1262) and 12% (64/542) of PLWH reported moderate/severe reactogenicity after the 1st and 2nd vaccination (Figure), with no hospitalizations. Female PLWH and CD4 count >500 had 35% (p=0.03) and 44% (p=0.04) increased odds of moderate/severe reactogenicity, respectively. Other baseline characteristics were not associated with the odds of reporting moderate/severe reactogenicity among PLWH after 1st vaccination. Similar trends were seen after the 2nd vaccination, but none reached statistical significance. In multivariate models, female sex remained associated with increased odds of moderate/severe reactogenicity after the 2nd vaccination. Conclusion(s): Similar to observations in HIV-negative populations, mRNA-1273 was well tolerated by PLWH with more reactogenicity in females. Impaired inflammatory responses among participants with CD4 counts < 500 cell/muL may explain less moderate/severe reactions.

Prediction of clinical outcomes in patients with coronavirus disease 2019 using high-sensitive troponin I and N-terminal pro-B-type natriuretic peptide

Background: Several comorbidities, including cardiovascular diseases or myocardial injury, are reported to be associated with poor prognosis in patients with Coronavirus disease 2019 (COVID-19). However, detailed prognostic analysis of myocardial injury by various biomarkers in COVID-19 patients is limited. Purpose(s): This study aims to explore the prognostic values of highsensitive Troponin I (hsTnI) and N-terminal pro-B-type natriuretic peptide (NT-proBNP) for COVID-19 patients using Japanese real-world data. Method(s): The COVID-MI study is a retrospective cohort study that enrolls consecutive laboratory-confirmed COVID-19 patients admitted to the hospital from July 2020 to September 2021. We collected clinical data, including cardiac biomarker values, by chart review. If the prespecified biomarkers in concern were not available, we measured them using the institutional serum blood bank, which enrolled patients prospectively from July 2020. Patients with available biomarkers were analyzed according to the values of hsTnI or NT-proBNP, using the clinically relevant thresholds (hsTnI: 5 ng/L and 99th percentile of the upper reference limit [99%ile URL], and NTproBNP: 125 pg/mL and 900 pg/mL). The primary outcome measure was all-cause death. Secondary outcome measures included acute respiratory distress syndrome, myocardial infarction, myocarditis/pericarditis, venous thromboembolism, cerebral infarction, and bleeding events. Result(s): We enrolled 917 patients with COVID-19 confirmed by viral nucleic acid amplification test. The mean age was 61 years, and 591 patients (64%) were men. On admission, the number of patients classified as severe or critical COVID-19 was 515 (56%) and 85 (8.7%), respectively. Among the 544 patients with hsTnI values, 365 (67%) patients had elevated hsTnI of >=5 ng/L, and 134 patients (25%) had TnI of >=99%ile URL. Besides, among 546 patients with NT-proBNP values, 295 patients (54%) had elevated NT-pro-BNP of >=125 pg/mL, and 93 patients (17%) had NT-proBNP of >=900 pg/mL. The median follow-up period was 31 days (interquartile range: 11-90 days). In cumulative incidence analysis, higher levels of hsTnI and NT-proBNP were associated with significantly higher mortality (hsTnI: <5 ng/L group;8.8%, 5 ng/L to 99%ile URL group;19%, and >=99%ile URL group;37%, P<0.001, and NT-proBNP: <125 pg/mL group;7.8%, 125 to 900 pg/mL group;21%, and >=900 pg/mL group;45%, P<0.001). The adjusted risk for all-cause death remained significant for each threshold of cardiac biomarkers (hsTnI >=99%ile URL: Hazard ratio [HR] 1.98, 95% confidence interval [CI] 1.11-3.54, P=0.02, and NT-proBNP >=900 pg/mL: HR 3.60, 95% CI 1.86-6.98, P<0.001). Conclusion(s): Elevation of hsTnI or NT-proBNP was associated with poor prognosis in the current relatively severely ill COVID-19 patients. Measuring hsTnI or NT-proBNP can be an attractive option for risk stratification and deciding appropriate management in patients with COVID-19.

Stimulus-Responsive DNA Hydrogel Biosensors for Food Safety Detection.

Food safety has always been a major global challenge to human health and the effective detection of harmful substances in food can reduce the risk to human health. However, the food industry has been plagued by a lack of effective and sensitive safety monitoring methods due to the tension between the cost and effectiveness of monitoring. DNA-based hydrogels combine the advantages of biocompatibility, programmability, the molecular recognition of DNA molecules, and the hydrophilicity of hydrogels, making them a hotspot in the research field of new nanomaterials. The stimulus response property greatly broadens the function and application range of DNA hydrogel. In recent years, DNA hydrogels based on stimulus-responsive mechanisms have been widely applied in the field of biosensing for the detection of a variety of target substances, including various food contaminants. In this review, we describe the recent advances in the preparation of stimuli-responsive DNA hydrogels, highlighting the progress of its application in food safety detection. Finally, we also discuss the challenges and future application of stimulus-responsive DNA hydrogels.

Multicenter post-marketing clinical evaluation on the clinical performance of the five domestic fast nucleic acid detection reagents for 2019-nCoV.

Objective This multicenter clinical evaluation analyzed the clinical performance of five fast nucleic acid detection systems for 2019-nCoV. Methods Clinical performance of the five fast nucleic acid detection reagents approved in China was evaluated in the present study. Fifty-seven throat swabs samples from COVID-19 patients and fifteen throat swabs samples from healthy people were collected from the First Affiliated Hospital of Zhejiang University school of Medicine, Tongji Hospital of Tongji Medical College of HUST, and National Institute of Viral Disease Control and Prevention of CDC to evaluate the positive coincidence rate, negative coincidence rate, total coincidence rate, the detection time and retest rate as well as the relation between positive intensity and positive coincidence rate of the five fast nucleic acid detection systems in November 2020. Results The positive coincidence rates of the five kits were 92.59% (50/54), 83.64% (46/55), 98.25% (56/57), 94.44% (51/54) and 98.18% (54/55);and the negative coincidence rates were 93.33% (14/15), 93.33% (14/15), 86.67% (13/15), 100% (14/14) and 93.33% (14/15);and the total coincidence rates were 92.75% (64/69), 85.71% (60/70), 95.83% (69/72), 94.20% (65/69) and 97.14% (68/70), respectively. The positive coincidence rate of the five kits reached 100% for the strong-positive (90/90) and medium-positive samples (84/84), but only 82.18% (83/101) for weak-positive samples (cycle threshold value>33), and the retest rate of two kits were 15.28% (11/72) and 12.50% (9/72), which were both higher than 10%. Total time from sample extraction to amplification was between 32.33-65.33 minutes for these five kits. Conclusion The five fast nucleic acid detection reagents have good performance and can be used as a supplement to routine nucleic acid detection reagents.Copyright © 2022 Chinese Journal of Laboratory Medicine. All rights reserved.

Rational Use of COVID-19 Virological Tests in Intensive Care Unit

The ongoing COVID-19 pandemic reminded once again that microbiological diagnostic methods are irreplaceable in both diagnosing and detecting asymptomatic persons. At present, real-time reverse transcriptase polymerase chain reaction (RT-PCR) is the gold standard method for diagnosing COVID-19, but the test's accuracy varies in sample quality. Especially in the last stages of the disease, negative results of nasopharyngeal or oropharyngeal swab samples or rapid antigen tests do not necessarily mean that these patients do not carry the virus. Considering that a significant number of COVID-19 patients need intensive care and mechanical ventilation in the late period, which sample should be taken from where and when should be evaluated. Lower respiratory tract samples have a more significant chance of finding viral RNA than upper respiratory tract samples. Technical recommendations and the virological diagnostic methodologies and used in the intensive care unit of patients infected with SARS-CoV-2 are summarized in this article. We aimed to emphasize the need to get a sample from the right place at the right time for a reliable virological diagnosis.Copyright © 2022 by The Cardiovascular Thoracic Anaesthesia and Intensive Care.

Programmatic advantage of cost-effective and highly sensitive rapid COVID-19 diagnostic with two-step screening strategy for airport quarantine in Bangladesh

Introduction: In the current pandemic, many unprecedented challenges have been observed at the resource poor settings such as inadequate airport quarantine facilities and lack of highly sensitive but rapid and cost-effective testing of COVID-19. Objective(s): To present a cost-effective and timely alternative diagnostic and quarantine facility for the incoming travelers in Bangladesh. Method(s): The cross-sectional serosurvey data has been collected from impoverished inbound travelers from different countries who were quarantined in Hajj camp (a government facility near the airport reserved for muslim pilgrims) with full coverage of food and lodging at subsidized cost and free testing by GeneXpert, which is capable of Nucleic Acid Amplification Test (NAAT) for both COVID-19 and TB. Result(s): Most of our study participants were male (74.32%) and the predominant age group was 20-40 years. Total SARS-COV-2 positive patients were 106 (7.98%) among 1328 participants out of which 72 were male. The highest infection rate was observed in travelers from Singapore (n=16/71, 22.53%) followed by USA and Malaysia. The result processing time was only 1 hour for the NAAT and 1222 participants (92%) were able to travel to their destinations on the same day. The positive cases were kept in quarantine for further assessment. Conclusion(s): Our study findings support the equitable access to COVID-19 diagnostics like NAAT for disadvantaged group and optimum use of health system resources. It also shows the potential to equip hard to reach laboratory facilities by GeneXpert for both TB and COVID-19 diagnostics specially where the double burden exists.

Treatment Effects of Integrated TCM and Western Medicine Treatment Scheme on COVID-19: A Single-armed Clinical Trial

Backgroud: The outbreak of COVID-19 has brought unprecedented perils to human health and raised public health concerns in more than two hundred countries. Safe and effective treatment scheme is needed urgently. Objective(s): To evaluate the effects of integratedTCM and western medicine treatment scheme on COVID-19. Method(s): A single-armed clinical trial was carried out in Hangzhou Xixi Hospital, an affiliated hospital with Zhejiang Chinese Medical University. 102 confirmed cases were screened out from 725 suspected cases and 93 of them were treated with integrated TCM and western medicine treatment scheme. Result(s): 83 cases were cured, 5 cases deteriorated, and 5 cases withdrew from the study. No deaths were reported. The mean relief time of fever, cough, diarrhea, and fatigue were (4.78 +/- 4.61) days, (7.22 +/- 4.99) days, (5.28 +/- 3.39) days, and (5.28 +/- 3.39) days, respectively. It took (14.84 +/- 5.50) days for SARS-CoV-2 by nucleic acid amplification-based testing to turn negative. Multivariable cox regression analysis revealed that age, BMI, PISCT, BPC, AST, CK, BS, and UPRO were independent risk factors for COVID-19 treatment. Conclusion(s): Our study suggested that integrated TCM and western medicine treatment scheme was effective for COVID-19.Copyright © 2021

COI vs Ct: comparing automated antigen tests cut-off index (COI) to PCR cycle threshold (Ct)

Introduction: The objective of this study was to compare the numeric cut-off index (COI) of automated antigen tests with the cycle-threshold (Ct) value. Materials and methods: COI values of all samples processed with the Elecsys® SARS-CoV-2 Antigen (Roche, Switzerland) from January to February 2022 were retrieved and the positive were compared to RdRP Cts of Allplex Variants I (Seegene, Korea). COI between 0.6 and 1 were considered indeterminate and overproved by RT-PCR. Results: From 13,937 samples 7944(57%) were positive and 189(1.35%) indeterminate. There was a strong correlation between Cts and COI values at the positive samples, but that was not the case for indeterminates. Conclusions: COI values of the positive samples (COI >1) are comparable to Ct values and may therefore be used as proxy viral loads, however this is not the case for indeterminate samples. © 2022 Elsevier Inc.

Multicenter post-marketing clinical evaluation on the clinical performance of the five domestic fast nucleic acid detection reagents for 2019-nCoV

Objective This multicenter clinical evaluation analyzed the clinical performance of five fast nucleic acid detection systems for 2019-nCoV. Methods Clinical performance of the five fast nucleic acid detection reagents approved in China was evaluated in the present study. Fifty-seven throat swabs samples from COVID-19 patients and fifteen throat swabs samples from healthy people were collected from the First Affiliated Hospital of Zhejiang University school of Medicine, Tongji Hospital of Tongji Medical College of HUST, and National Institute of Viral Disease Control and Prevention of CDC to evaluate the positive coincidence rate, negative coincidence rate, total coincidence rate, the detection time and retest rate as well as the relation between positive intensity and positive coincidence rate of the five fast nucleic acid detection systems in November 2020. Results The positive coincidence rates of the five kits were 92.59% (50/54), 83.64% (46/55), 98.25% (56/57), 94.44% (51/54) and 98.18% (54/55);and the negative coincidence rates were 93.33% (14/15), 93.33% (14/15), 86.67% (13/15), 100% (14/14) and 93.33% (14/15);and the total coincidence rates were 92.75% (64/69), 85.71% (60/70), 95.83% (69/72), 94.20% (65/69) and 97.14% (68/70), respectively. The positive coincidence rate of the five kits reached 100% for the strong-positive (90/90) and medium-positive samples (84/84), but only 82.18% (83/101) for weak-positive samples (cycle threshold value>33), and the retest rate of two kits were 15.28% (11/72) and 12.50% (9/72), which were both higher than 10%. Total time from sample extraction to amplification was between 32.33-65.33 minutes for these five kits. Conclusion The five fast nucleic acid detection reagents have good performance and can be used as a supplement to routine nucleic acid detection reagents.

Multicenter post-marketing clinical evaluation on the clinical performance of the five domestic fast nucleic acid detection reagents for 2019-nCoV

Objective This multicenter clinical evaluation analyzed the clinical performance of five fast nucleic acid detection systems for 2019-nCoV. Methods Clinical performance of the five fast nucleic acid detection reagents approved in China was evaluated in the present study. Fifty-seven throat swabs samples from COVID-19 patients and fifteen throat swabs samples from healthy people were collected from the First Affiliated Hospital of Zhejiang University school of Medicine, Tongji Hospital of Tongji Medical College of HUST, and National Institute of Viral Disease Control and Prevention of CDC to evaluate the positive coincidence rate, negative coincidence rate, total coincidence rate, the detection time and retest rate as well as the relation between positive intensity and positive coincidence rate of the five fast nucleic acid detection systems in November 2020. Results The positive coincidence rates of the five kits were 92.59% (50/54), 83.64% (46/55), 98.25% (56/57), 94.44% (51/54) and 98.18% (54/55);and the negative coincidence rates were 93.33% (14/15), 93.33% (14/15), 86.67% (13/15), 100% (14/14) and 93.33% (14/15);and the total coincidence rates were 92.75% (64/69), 85.71% (60/70), 95.83% (69/72), 94.20% (65/69) and 97.14% (68/70), respectively. The positive coincidence rate of the five kits reached 100% for the strong-positive (90/90) and medium-positive samples (84/84), but only 82.18% (83/101) for weak-positive samples (cycle threshold value>33), and the retest rate of two kits were 15.28% (11/72) and 12.50% (9/72), which were both higher than 10%. Total time from sample extraction to amplification was between 32.33-65.33 minutes for these five kits. Conclusion The five fast nucleic acid detection reagents have good performance and can be used as a supplement to routine nucleic acid detection reagents. © 2022 Chinese Journal of Laboratory Medicine. All rights reserved.

ATYPICAL PRESENTATION OF MUCORMYCOSIS IN A NONSEVERE COVID-19 PATIENT

SESSION TITLE: COVID-19 Case Report Posters 2 SESSION TYPE: Case Report Posters PRESENTED ON: 10/19/2022 12:45 pm - 01:45 pm INTRODUCTION: Coronavirus Disease 2019 (COVID-19) infection ranges from asymptomatic to severe disease as defined by WHO. Emerging fungal infections such as mucormycosis and aspergillosis have been described in critically ill patients, most notably in India, when treated with steroids due to severe COVID-19 [1]. We present a unique case of an atypical presentation of mucormycosis in a non-severe COVID-19 patient not treated with corticosteroids. CASE PRESENTATION: A 19-year-old male with type 1 diabetes mellitus presented to the emergency room for evaluation of shortness of breath, nausea and fatigue. History was significant for insulin noncompliance with home blood glucose in the 300s and a positive COVID-19 test one day prior to arrival. Initial vitals positive for tachycardia, tachypnea and hypertension while on room air. Labs showed leukocytosis 14,000 cells/uL, bicarbonate 7.2 mmol/L, anion gap 24.8, glucose 428 mg/dL, beta-hydroxybutyrate 58 mg/dL and nucleic acid amplification COVID-19 positive. Physical exam showed left eyelid and facial swelling, nasal congestion without sinus tenderness or other deformity, and kussmaul breathing pattern. CT face confirmed left periorbital cellulitis. Transfer to tertiary center for Ophthalmology evaluation was attempted but refused due to capacity. He was started on diabetic ketoacidosis treatment as well as broad spectrum antibiotics with the assistance of Infectious Disease, however COVID-19 treatments were held due to mild illness. Despite these interventions, he became stuporous and amphotericin was started. MR Brain showed findings suggestive of cavernous sinus thrombosis, acute ischemia and local mass effect. ENT then performed an endoscopic antrostomy with ethmoidectomy and biopsies were taken. Pathology resulted as invasive fungal sinusitis with 90° branching hyphae confirming mucormycosis and a lumbar drain was placed with intrathecal amphotericin started for concern of mucormycosis meningitis. The patient was ultimately transferred to a tertiary care center where he expired. DISCUSSION: Mucormycosis, an angioinvasive fungal infection affecting the immunocompromised and diabetics, is rare but deadly. The estimated prevalence in the United States is 0.16 per 10,000 hospital discharges [2] and bears a mortality rate of 46%. Recent systematic reviews report 275 cases of COVID associated mucormycosis with 233 in India [1] with 76.3% receiving corticosteroids prior to diagnosis [3], likely contributing to an immunocompromised state. Our case demonstrates that despite not receiving corticosteroids, even those with mild COVID-19 are at risk for this disease. CONCLUSIONS: Patients with diabetes, immunocompromised states, and now COVID-19, presenting with orbital symptoms warrant consideration of mucormycosis. Prompt management of the underlying condition, IV amphotericin, and possible debridement may increase survival. Reference #1: John TM, Jacob CN, Kontoyiannis DP. When Uncontrolled Diabetes Mellitus and Severe COVID-19 Converge: The Perfect Storm for Mucormycosis. J Fungi (Basel). 2021 Apr 15;7(4):298. doi: 10.3390/jof7040298. PMID: 33920755;PMCID: PMC8071133. Reference #2: Kontoyiannis DP, Yang H, Song J, et al. Prevalence, clinical and economic burden of mucormycosis-related hospitalizations in the United States: a retrospective study. BMC Infect Dis. 2016;16(1):730. Published 2016 Dec 1. doi:10.1186/s12879-016-2023-z Reference #3: Singh AK, Singh R, Joshi SR, Misra A. Mucormycosis in COVID-19: A systematic review of cases reported worldwide and in India. Diabetes Metab Syndr. 2021 Jul-Aug;15(4):102146. doi: 10.1016/j.dsx.2021.05.019. Epub 2021 May 21. PMID: 34192610;PMCID: PMC8137376 DISCLOSURES: No relevant relationships by james abraham No relevant relationships by christian ALMANZAR ZORRILLA No relevant relationships by Grace Johnson No relevant relationships by Thanuja Neerukonda No relevant relationships by Blake Spain No relevant re ationships by Michael Su No relevant relationships by Steven Tran No relevant relationships by Margarita Vanegas No relevant relationships by Alexandra Witt

A collaborative study to establish the national standard for SARS-CoV-2 RNA nucleic acid amplification techniques (NAAT) in Taiwan.

The conventional PCR remains a valuable method to detect the newly emergent coronavirus rapidly and accurately. Our investigation aimed to establish the standard materials of SARS-CoV-2 for NAAT detection. We provided formalin-inactivated SARS-CoV-2 and confirmed RNA copy numbers. In addition, the virus genome was confirmed with whole-genome sequencing and identified as Wuhan/WI04/2019. Seven laboratories were invited for this collaborative study, according to the reporting data, we determined the SARS-CoV-2 with the unit of 6.35 Log10 copies/mL as the national standard. The availability of the national standard (NS) of SARS-CoV-2 will facilitate the standardization and harmonization of SARS-CoV-2 NAAT assays.

A precise review on NAATs-based diagnostic assays for COVID-19: A motion in fast POC molecular tests.

BACKGROUND: Diagnosis is one of the main strategies to deal with infectious and deadly diseases such as coronavirus disease 2019 (COVID-19). The global pandemic of COVID-19 has led to an immediate need to expand rapid diagnostic techniques. New isothermal-based methods are being developed for COVID-19 detection aiming to resolve the limitations related to the reverse transcription-quantitative polymerase chain reaction (RT-qPCR) method through immediate samples processing and minimizing false-negative or ambiguous results. Advances in nucleic acid amplification techniques (NAATs) can provide affordable and easy-to-use diagnostic platforms with high sensitivity and specificity in order to be available to the public as approved commercial kits. AIMS: The development of point-of-care (POC) testing can assist in rapid clinical decision-making and mitigate burdens on health care facilities. Finally, we discussed the different diagnostic methods based on NAATs for COVID-19 in detail. Comparative parameters are addressed for all assays and Emergency Use Authorizations (EUA)-approved commercial tests are cited. CONCLUSIONS: Isothermal-coupled methods and LAMP-based molecular methods have been suggested as suitable portable tests with high diagnostic speed for use in POC testing.

An isothermal lab-on-phone test for easy molecular diagnosis of SARS-CoV-2 near patients and in less than 1 hour.

OBJECTIVES: The performance of a new point-of-care CE-IVD-marked isothermal lab-on-phone COVID-19 assay was assessed in comparison to a gold standard real-time reverse transcriptase-PCR method. METHODS: The study was conducted following a nonprobability sampling of ≥16-year-old volunteers from three different laboratories, using direct mouthwash (N = 24) or nasopharyngeal (N = 191) clinical samples. RESULTS: The assay demonstrated 95.19% sensitivity and 100% specificity for detection of SARS-CoV-2 in direct nasopharyngeal crude samples and 78.95% sensitivity and 100% specificity in direct mouthwash crude samples. It also successfully detected currently predominant SARS-CoV-2 variants of concern (Beta B.1.351, Delta B.1.617.2, and Omicron B.1.1.529) and demonstrated to be inert against potential cross-reactions of other common respiratory pathogens that cause infections that present similar symptoms to COVID-19. CONCLUSION: This lab-on-phone pocket-sized assay relies on an isothermal amplification of SARS-CoV-2's N and E genes, taking just 50 minutes from sample to result, with only 2 minutes of hands-on time. It presents good performance when using direct nasopharyngeal crude samples, enabling a low-cost, real-time, rapid, and accurate identification of SARS-CoV-2 infections at the point of care, which is important for both clinical management and population screening, as a tool to break the chain of transmission of COVID-19 pandemic, especially in low-resources environments.

RAPID POINT-OF-CARE DIAGNOSIS OF CT/NG USING EXPAR DNA AMPLIFICATION COUPLED TO A NOVEL OPTICAL DETECTION SYSTEM

Introduction The Covid-19 pandemic has dramatically accelerated the point of care (POC) landscape, increasing awareness and demand for rapid diagnostics of other diseases. STIs are a major current health issue, with Neisseria gonorrhoea (NG) and Chlamydia trachomatis (CT) being highly prevalent. Current diagnostic methods are not POC and the most rapid takes around 20 mins. We have developed a new molecular assay, taking < 10 minutes for a diagnostic result, and combined it with a novel, rapid detection mechanism to produce a fully integrated POC device. Methods Our assay will make use of the exponential amplification reaction (EXPAR), a rapid isothermal DNA amplification technique, to produce an output detectable by Linear Dichroism (LD). LD is a highly sensitive optical detection technique, relying on exploiting structural properties of a scaffold such as M13 bacteriophage. Adapting EXPAR and combining it with a DNA sensitive LD assay allows detection of specific DNA sequences, signalling the presence of CT and/or NG. A principal advantage of our system is it allows multiplexing on the same detection scaffold. Results Initial clinical trials using EXPAR show detection of CT/NG patient samples within 10 minutes of DNA amplification at a constant temperature. The sequences detected represent specific and well conserved regions of CT and NG. Large signal changes give M13 a high analytical sensitivity. Discussion Our systems will ensure faster and more accurate diagnosis and ultimately better patient health outcomes. We are currently focused on an expansion of the scope of diseases that we can detect, using our in-house sequence selection process. (Figure Presented).

OUTCOMES OF SELF-TAKEN GENITAL NEISSERIA GONORRHOEAE CULTURE SWABS IMPLEMENTED TO REDUCE DIRECT PATIENT CONTACT DURING THE COVID-19 PANDEMIC

Introduction Obtaining samples of Neisseria gonorrhoeae for antibiotic sensitivity testing is important for purposes of antimicrobial stewardship. While urethral and cervical gonorrhoea culture samples are usually taken by a healthcare professional, the Covid-19 pandemic necessitated a reduction in direct patient contact. In our service, patients with confirmed gonorrhoea who did not otherwise require examination were asked to take their own urethral or vaginal culture swabs. Methods GUMCAD coding was used to identify cases of cervical or male urethral Neisseria gonorrhoeae infection diagnosed on nucleic acid amplification testing, where the gonococcal culture result and the identity of the swab-taker (patient/healthcare professional) were recorded in the notes. 50 cases were selected in 2019, and 50 in 2020, after the onset of the Covid-19 pandemic. Proportions of patients taking their own swabs were calculated for the two periods. Culture positivity rates were compared between self-taken and healthcare professional-taken swabs. Results During the pandemic, use of self-taken culture samples increased ten-fold. Although positivity for Neisseria gonorrhoeae was lower for self-taken swabs, 38% of male self-taken urethral samples tested positive for gonorrhoea, and the organism was successfully cultured from a self-taken vaginal swab on one occasion. Discussion Although self-taken gonorrhoea cultures were less likely to grow Neisseria gonorrhoeae than those taken by healthcare professionals, they proved a useful tool in gathering sensitivity data in a time of restricted patient contact. The lower positivity rate of self-taken cultures may be partially attributable to their use in patients with fewer symptoms, and hence a lower bacterial load. (Table Presented).

Knowledge, Attitude and Practices Regarding Utility of CBNAAT in the Diagnosis of SARS-CoV-2 Disease among Medical Interns: A Cross-sectional Study

Introduction: Coronavirus Disease-2019 (COVID-19) causes respiratory tract infections in human beings ranging from mild illnesses like common cold to severe disease like pneumonia. Currently, nucleic acid amplification tests Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), Cartridge Based Nucleic Acid Amplification Test (CBNAAT) and Truenat) and rapid antigen detection tests are approved for diagnostic purpose by Indian Council of Medical Research (ICMR). Medical Interns, the primary contact health-care personnel, need to be sensitised regarding proper utilisation of CBNAAT, so that rapid and accurate diagnosis of Severe Acute Respiratory Syndrome Corona Virus 2 (SARS-CoV-2) can be made in comparison to the more commonly used RT-PCR technique. Aim: To evaluate the Knowledge, Attitude and Practices (KAP) of Bachelor of Medicine and a Bachelor of Surgery (MBBS) interns towards accessibility of CBNAAT in SARS-CoV-2 infection in a tertiary care hospital. Materials and Methods: A cross-sectional study was performed through questionnaire shared via online platform amongst 102 Medical interns working at College of Medicine and Sagore Dutta Hospital from 22nd August 2021 to 21st September 2021. Based on their response, KAP was assessed by using a three-point Likert Scale. The collected data was entered in Microsoft excel, and reported as frequencies and percentages. Results: Among 102 internees, 84 interns responded. Among 84 medical interns 31% had good, 50% had average whereas 19% had poor level of knowledge. About 58 (69%) agreed that CBNAAT can be used as a method for rapid diagnosis of SARS-CoV-2. About 75 (89.3%) answered that they are sending samples for COVID-19 testing. Only 56 (66.7%) agreed that CBNAAT should be recommended. Conclusion: This study revealed that majority of the MBBS interns had positive attitude towards different aspects of CBNAAT utility but most of them had gaps in their KAP. This demands extra efforts to sensitise and train them adequately.