Analytical and Clinical Performance of the NeuMoDx™ Platform for Cytomegalovirus and Epstein-Barr Virus Viral Load Testing.

DNA assays for viral load (VL) monitoring are key tools in the management of immunocompromised patients with cytomegalovirus (CMV) or Epstein-Barr virus (EBV) infection. In this study, the analytical and clinical performances of the NeuMoDx™ CMV and EBV Quant Assays were compared with artus CMV and EBV QS-RGQ Kits in a primary hospital testing laboratory. Patient plasma samples previously tested using artus kits were randomly selected for testing by NeuMoDx assays. The NeuMoDx CMV Quant Assay and artus CMV QS-RGQ Kit limits of detection (LoDs) are 20.0 IU/mL and 69.7 IU/mL, respectively; 33/75 (44.0%) samples had CMV DNA levels above the LoD of both assays. The Pearson correlation coefficient was 0.9503; 20 samples (60.6%) had lower NeuMoDx CMV quantification values versus the artus kit. The LoD of the NeuMoDx EBV Quant Assay and artus EBV QS-RGQ Kit are 200 IU/mL and 22.29 IU/mL, respectively; 16/75 (21.3%) samples had EBV DNA levels above the LoD of both assays. The Pearson correlation coefficient was 0.8990. EBV quantification values with the NeuMoDx assay were higher versus the artus kit in 15 samples (93.8%). In conclusion, NeuMoDx CMV and EBV Quant Assays are sensitive and accurate tools for CMV and EBV DNA VL quantification.

El rol del laboratorio en los hallazgos de intoxicación y exposición a monóxido de carbono / The role of the laboratory in findings of carbon monoxide poisoning and exposure

El monóxido de carbono es un gas altamente tóxico que se origina principalmente por la combustión incompleta de combustibles fósiles. La intoxicación presenta síntomas inespecíficos que solapan otras patologías y por lo tanto es indispensable la confirmación mediante la medición de la carboxihemoglobina en sangre. El laboratorio incorporó la determinación en el informe del estado ácido base a partir de octubre del 2018, debido a que previamente el médico debía solicitarla frente a la sospecha de una intoxicación. El objetivo del trabajo fue evaluar si esta medida implementada por el laboratorio contribuyó a mejorar el diagnóstico de intoxicación por CO, analizar las características de los pacientes con COHb mayor o igual a 5% y definir un valor de reporte inmediato para la COHb. El 46% de los casos con COHb mayor o igual a 5% no se relacionaban con una intoxicación y/o exposición a CO. De los casos de intoxicación se encontró que el 77% fueron diagnosticados a partir de la sospecha médica y un 23% por hallazgo del laboratorio. Se concluyó que es de mucha utilidad el rol del laboratorio en detectar aquellos casos que no fueron evidentes clínicamente. Existen ciertas patologías como las oncológicas o la enfermedad de Wilson donde se vieron valores elevados de COHb sin presentar intoxicación y se definió finalmente, como valor de reporte inmediato 7% para la COHb. (AU)

Carbon monoxide is a highly toxic gas that originates mainly from incomplete combustion of fossil fuels. Intoxication causes nonspecific symptoms that overlap with other conditions and, therefore, confirmation by measuring blood carboxyhemoglobin is essential. The laboratory incorporated the measurement in the acid-base status report as of October 2018, as it was previously required to be requested by the physician in case of suspected intoxication. The aim of this study was to evaluate whether this measure implemented by the laboratory contributed to the improvement of the diagnosis of CO intoxication, to analyze the characteristics of patients with COHb greater than or equal to 5% and to define an immediate reporting value for COHb. Overall, 46% of the cases with COHb greater than or equal to 5% were not related to CO poisoning and/or exposure. Of the cases of intoxication, 77% were diagnosed based on medical suspicion and 23% on laboratory findings. It was concluded that the laboratory has a useful role in detecting cases that were not clinically evident. There are certain diseases including different types of cancer or Wilson's disease where elevated COHb values were seen without intoxication and finally, 7% for COHb was defined as the immediate reporting value (AU)

Una experiencia de siete años en el laboratorio de Micología del Hospital de Pediatría Juan P. Garrahan / A seven-year experience in the Mycology Laboratory of Hospital de Pediatría Juan P. Garrahan

En noviembre del año 2015 nos incorporamos al Laboratorio de Micología del Servicio de Microbiología del Hospital Garrahan. En este breve resumen queremos compartir los avances logrados a través de nuestra experiencia durante siete años de trabajo profesional. Debido a los diagnósticos realizados y su complejidad, consideramos que el Hospital Garrahan, sus pacientes y la comunidad toda necesitan contar con un laboratorio de Micología que responda a sus necesidades. Creemos haber iniciado un camino que esperamos continúe y culmine con la creación de la Unidad de Micología (AU)

In November 2015 we joined the Mycology Laboratory of the Microbiology Service of the Hospital Garrahan. In this brief summary we want to share the advances achieved through our experience during seven years of professional work. Due to the diagnosis made and their complexity, we believe that the Hospital Garrahan, its patients and the entire community, need to have a Mycology laboratory that responds to their requirements. We believe we have started a path that we hope will continue and culminate with the creation of the Mycology Unit (AU)

Methylene Blue for the Treatment of Health Conditions: a Scoping Review

HIGHLIGHTS This scoping review summarizes the findings of clinical trials using methylene blue (MB) for the treatment of various health conditions. This research method allowed mapping main findings, clarifying research topics, and identifying gaps in the literature.

Abstract studies evaluating effective drugs for health conditions are of crucial importance for public health. Methylene blue (MB) is an accessible synthetic drug that presents low toxicity and has been used in several health areas due to its effectiveness. Objective: this scoping review aims to provide a comprehensive overview of relevant research regarding the use of MB for the treatment of health conditions. Methods: a five-stage framework Arksey and O'maley scoping review was conducted. The literature was searched in Cochrane Library database using Mesh term "methylene blue". Data were collected by two independent reviewers and submitted to descriptive synthesis. Results: The search resulted in 429 records, from which 16 were included after exclusion criteria were applied. The therapeutic use of MB was identified for acute conditions (malaria and septic shock), chronic conditions (discogenic back pain, bipolar disorder, refractory neuropathic pain, and post-traumatic stress disorder), and postoperative care (vasoplegic syndrome, and pain after haemorrhoidectomy, lumbar discectomy, and traumatic thoracolumbar fixation). Conclusion: there is much evidence emerging from clinical trials about the therapeutic use of MB for acute, chronic, and postoperative conditions; however, many gaps were identified, which open further avenues for future research.

Fractured aluminum nasopharyngeal swab during drive-through testing for COVID-19: radiographic detection of a retained foreign body.

The ongoing coronavirus disease 2019 (COVID-19) pandemic has increased the need for safe and efficient testing as a key containment strategy. Drive-through testing with nasopharyngeal swab has been implemented in many places in the USA as it allows for expeditious testing of large numbers of patients, limits healthcare workers' risk of exposure, and minimizes the use of personal protective equipment. We present a case where the aluminum shaft of the nasopharyngeal swab fractured during specimen collection at a drive-through testing facility and was suspected to have remained in the asymptomatic patient. Initial evaluation with a series of radiographs covering the skull base, neck, chest, and abdomen did not reveal the swab. On further clinical evaluation, the swab was found endoscopically, lodged between the left inferior turbinate and nasal floor, and was removed by an otorhinolaryngologist. Using a phantom model, we aimed to delineate an imaging technique to better visualize the aluminum shaft of the nasopharyngeal swab on radiographs to help in identification. A technique using lower tube voltage (kVp) with tight collimation centered at the nasal bones area produced the best visualization of the aluminum shaft of the swab. Recognition that aluminum foreign bodies may be difficult to visualize radiographically and  optimization of radiograph acquisition technique may help guide clinical management in unusual cases. Further evaluation with computed tomography or endoscopy should be considered in suspected cases where radiographs are negative.

Head-to-Head Comparison of Two SARS-CoV-2 Serology Assays.

BACKGROUND: While molecular techniques remain the gold standard for diagnosis of acute SARS-CoV-2 infection, serological tests have the unique potential to ascertain how much of the population has been exposed to the COVID-19 pathogen. There have been limited published studies to date documenting the performance of SARS-CoV-2 antibody assays. METHODS: We compared the DiaSorin Liaison SARS-CoV-2 S1/S2 IgG and Roche Diagnostics Elecsys Anti-SARS-CoV-2 assays using 228 samples spanning patients with positive PCR for SARS-CoV-2, patients with compatible symptoms but negative PCR, pre-COVID specimens, and potential cross-reactives. RESULTS: Both assays detected antibodies in 18/19 samples collected at least one week after a positive PCR result. Neither method consistently detected antibodies in specimens collected within one week of a positive PCR result (sensitivity < 50%), but antibodies were detected by only Roche in four samples in this time frame. Using 139 pre-COVID and 35 PCR-negative samples, the Roche and DiaSorin assays demonstrated specificities of 100.0% and 98.9%, respectively. Neither assay demonstrated cross-reactivity from other coronaviruses (229E, HKU1, NL63, OC43), respiratory pathogens (adenovirus, metapneumovirus, rhinovirus/enterovirus), or antibodies to other viruses (HIV, EBV, CMV, HBV, HCV, HAV). DISCUSSION: Overall, the qualitative interpretations afforded by the Roche and DiaSorin assays agreed for 97% of samples evaluated. Minor discrepancies in sensitivity and specificity were observed between methods, with the differences in specificity more clinically significant for our low-prevalence population. For the DiaSorin assay, all disagreements with the Roche assay occurred in samples with quantitative signals near the cut-off determining positivity.

3D-Printing to Address COVID-19 Testing Supply Shortages.

The recent SARS-CoV-2 outbreak has placed immense pressure on supply chains, including shortages in nasopharyngeal (NP) swabs. Here, we report our experience of using 3D-printing to rapidly develop and deploy custom-made NP swabs to address supply shortages at our healthcare institution.

Evaluating the use of posterior oropharyngeal saliva in a point-of-care assay for the detection of SARS-CoV-2.

During the Coronavirus disease 2019 (COVID-19) pandemic, logistic problems associated with specimen collection limited the SARS-CoV-2 testing, especially in the community. In this study, we assessed the use of posterior oropharyngeal saliva as specimens for the detection of SARS-CoV-2 in an automated point-of-care molecular assay. Archived nasopharyngeal swab (NPS) and posterior oropharyngeal saliva specimens of 58 COVID-19 patients were tested with the Xpert® Xpress SARS-CoV-2 assay. SARS-CoV-2 was detected in either NPS or saliva specimens of all patients. Among them, 84.5% (49/58) tested positive in both NPS and saliva, 10.3% (6/58) tested positive in NPS only, and 5.2% (3/58) tested positive in saliva only. No significant difference in the detection rate was observed between NPS and saliva (McNemar's test p = 0.5078). The detection rate was slightly higher for N2 (NPS 94.8% and Saliva 93.1%) than that of the E gene target (Saliva: 89.7% vs 82.8%) on both specimen types. Significantly earlier median Ct value was observed for NPS comparing to that of saliva on both E (26.8 vs 29.7, p = 0.0002) and N2 gene target (29.3 vs 32.3, p = 0.0002). The median Ct value of E gene target was significantly earlier than that of the N2 gene target for both NPS (26.8 vs 29.3, p < 0.0001) and saliva (29.7 vs 32.3, p < 0.0001). In conclusion, posterior oropharyngeal saliva and NPS were found to have similar detection rates in the point-of-care test for SARS-CoV-2 detection. Since posterior oropharyngeal saliva can be collected easily, the use of saliva as an alternative specimen type for SARS-CoV-2 detection is recommended.

Application of a portable instrument for rapid and reliable detection of SARS-CoV-2 infection in any environment.

The ongoing outbreak of the novel coronavirus (SARS-CoV-2) infection is creating serious challenges for health laboratories that seek to identify viral infections as early as possible, optimally at the earliest appearance of symptom. Indeed, there is urgent need to develop and deploy robust diagnostic methodologies not only to use in health laboratory environments but also directly in places where humans circulate and spread the virus such as airports, trains, boats, and any public aggregation places. The success of a reliable and sensitive asymptomatic diagnosis relies on the identification and measurement of informative biomarkers from human host and virus in a rapid, sensitive, and inexpensive manner. The objective of this article is to describe an innovative multidisciplinary approach to develop an efficient, inexpensive, and easy-to-use portable instrument (bCUBE® by Hyris Ltd) that can be employed as a surveillance system for the emergency caused by SARS-CoV-2. A solution for Coronavirus testing, compliant with CDC guidelines, is scheduled to be released in the next weeks. In addition, we will describe a workflow and path of an integrated multi-omic approach that will lead to host and pathogen biomarker discovery in order to train the instrument to provide reliable results based on a specific biomarker's fingerprint of SARS-CoV-2 infection.

Clinical Accuracy of a New Rapid Assay for Fecal Calprotectin Measurement.

BACKGROUND: Fecal calprotectin is an excellent biomarker for distinguishing inflammatory bowel disease from irritable bowel syndrome and for evaluation of disease activity in Crohn's disease and ulcerative colitis. The aim of this work was to evaluate the analytical performance of a new flow immune chromatography assay by comparing it to our standardized laboratory gold standard system. METHODS: A total of 100 stool samples sent for routine calprotectin level measurements were analyzed by the Liaison XL system and the QuantOn Cal assay simultaneously using the same cutoff values for both assays. Performance of the QuantOn Cal assay was assessed by calculating sensitivity, specificity, and accuracy. RESULTS: Compared with the gold standard, the sensitivity, specificity, and accuracy of the QuantOn Cal assay were 98.7%, 76.2%, and 94.0%, respectively. Furthermore, linear correlation of calprotectin levels between the two assays were found to be significant by Pearson's correlation coefficient test (r = 0.82, p-values < 0.0001). CONCLUSIONS: The QuantOn Cal assay demonstrated good performance, both qualitative and quantitative when compared to the Liaison XL system. This novel and rapid assay is well suited for measuring fecal calprotectin as a point of care or home-based assay when laboratory services are limited or not available.

Evaluation of Contamination Risk by the cobas e 602 Serology Module Before Viral Load Testing on the cobas 6800 System.

BACKGROUND: Diagnosis of HCV, HBV, and HIV involves antibody screening followed by confirmation and/or treatment decision using nucleic acid tests. However, minimal data exist evaluating the risk of nucleic acid cross-contamination on serology devices upstream of molecular testing despite the potential clinical and laboratory workflow advantages of single specimen vial testing for both procedures. METHODS: We conducted a checkerboard study investigating the potential risk of HCV, HBV, and HIV nucleic acid cross-contamination on 480 negative specimens by a serology screening instrument that uses disposable tips for sample transfer, rather than a fixed needle, before molecular testing. RESULTS: Nucleic acid contamination was observed in 0 of 480 negative specimens when processed with alternating high-titer HCV, HBV, or HIV specimens on the serology platform. CONCLUSIONS: This study suggests that specimens analyzed by a serology instrument using disposable tips for sample transfer may be suitable for direct primary specimen reflex testing by a sensitive nucleic acid confirmatory test.

Structure-dependent retention of steroid hormones by common laboratory materials.

The tendency of steroid molecules to adsorb to various materials, particularly plastics, has been known of for decades but has not received widespread attention in the scientific community, and a modern, systematic study is lacking. This adsorption is an important consideration for researchers working with steroid hormones as it could skew the results of various experiments. Here we show that steroids adsorb to various vessels used in experiments, including microcentrifuge tubes, glass vials, and cell culture plates, in a manner that depends on the steroid's molecular structure and on the type of vessel. The lipophilicity of steroids is a strong predictor of the degree of adsorption, with nearly 50 % of the most lipophilic steroid tested, pregnenolone, retained in a high-adsorbing microcentrifuge tube after one hour incubation of an aqueous pregnenolone solution followed by removal of the aqueous solvent. We also show the effects of other factors such as incubation time, centrifugation, and temperature on adsorption, and show that adsorption can be mostly prevented by the presence of serum proteins in steroid solutions and/or by the use of low-adsorbing tubes.

Association between soluble biomarkers - microbial translocation, inflammation and cardiovascular risk in HIV- infected individuals: a systematic review

Microbial translocation is associated with the increased risk of cardiovascular disease in HIV-infected individuals. There is scarce information regarding the possible associations between the biomarkers of microbial translocation, inflammation and cardiovascular risk that can be evaluated in clinical laboratories using plasma or serum samples. This systematic review was conducted according to the PRISMA protocol in order to verify the most used soluble biomarkers of microbial translocation, inflammation and cardiovascular risk, as well as possible associations between them, in HIV-infected individuals. A search was performed using the Medline, Scopus and Web of Science databases to identify existing studies regarding the relationship between microbial translocation biomarkers, inflammation and cardiovascular risk in HIV-infected patients. Eleven articles that presented soluble biomarkers of microbial translocation (LPS, rDNA, sCD14, LBP and EndoCAb) were selected. The most frequently evaluated soluble biomarker was sCD14, followed by LPS; the latter were associated with some lipid profile parameters. This systematic review considered soluble blood biomarkers that can be utilized in laboratory diagnosis. The aim was to identify the interconnection between microbial translocation, inflammation and cardiovascular risk. Despite the fact that a large number of inflammation and cardiovascular risk biomarkers have been previously reported, it was noted that important markers involved in the pathophysiology of cardiovascular diseases need to be included in future research.

Respuesta del score RIPASA versus el histopatológico como predictor diagnóstico de apendicitis aguda en el Hospital Vicente Corral Moscoso año 2018 / Response of the RIPASA score versus the histopathology as a diagnostic predictor of acute appendicitis at the Vicente Corral Moscoso Hospital in 2018

Antecedentes: la Apendicitis Aguda (A.A) es una urgencia quirúrgica que requiere un diagnóstico y tratamiento oportuno. Muchas veces puede ser un gran reto para el cirujano por su relación con otras patologías, de allí la importancia de precisar su diagnóstico. Objetivo: validar la precisión diagnóstica del score RIPASA en apendicitis aguda comparándolo con el examen histopatológico. Metodología: se realizó un estudio de validación de pruebas diagnósticas con la información de 300 historias clínicas de pacientes apendicectomizados, atendidos en el Hospital Vicente Corral Moscoso durante el año 2018. Se evaluó mediante el score RIPASA al ingreso y se comparó con los resultados de histopatología como prueba gold standar. Se calculó la sensibilidad, especificidad, valor predictivo positivo, valor predictivo negativo, además se obtuvo Odds Ratio con su IC al 95% para establecer la validez predictiva de esta escala. Resultados: la media de edad fue de 32 años ± 13,7 (DS), más de la mitad fueron: sexo femenino 52%, área urbana 74.7% y bachillerato 62.7%, predominó la etnia mestiza 99.7%. Hubo una asociación de riesgo entre una alta probabilidad de apendicitis según el score RIPASA con A.A (OR 96,36; IC95%: 16,03­578,68; p= 0,000). El score RIPASA tiene una sensibilidad de 98.97%, especificidad 50.0%, VPP 98.63%, VPN 57,14%, RVP 1.98% Y RVN 0.2%. Conclusiones: RIPASA tiene alta probabilidad para detectar a personas con apendicitis aguda, pero no así a las sanas, por lo cual se requiere continuar con más estudios para establecer tal validez

Background: Acute Appendicitis (A.A) is a surgical emergency that requires timely diagnosis and treatment. Many times it can be a great challenge for the surgeon because of its relationship with other pathologies, hence the importance of specifying its diagnosis. Objective: To validate the diagnostic accuracy of the RIPASA score in acute appendicitis by comparing it with the histopathological examination. Methodology: A study of validation of diagnostic tests was carried out with the information of 300 medical records of appendectomized patients, treated at the Vicente Corral Moscoso Hospital during 2018. It was evaluated by means of the RIPASA score at admission and compared with the histopathology results. as gold standard test. Sensitivity, specificity, positive predictive value, negative predictive value were calculated, in addition Odds Ratio was obtained with its 95% CI to establish the predictive validity of this scale. Results: The mean age was 32 years ± 13.7 (SD), more than half were: female 52%, urban area 74.7% and high school 62.7%, mixed race ethnicity predominated 99.7%. There was a risk association between a high probability of appendicitis according to the RIPASA score with A.A (OR 96.36; 95% CI: 16.03­578.68; p = 0.000). The RIPASA score has a sensitivity of 98.97%, specificity 50.0%, PPV 98.63%, NPV 57.14%, RVP 1.8% and RVN 0.2% Conclusions: RIPASA has a high probability of detecting people with acute appendicitis, but not healthy ones, so it is necessary to continue with more studies to find such validity