Clinical Performance and Analytical Sensitivity of Three SARS-CoV-2 Nucleic Acid Diagnostic Tests

ABSTRACTHundreds of RT-qPCR kits are available in the market for SARS-CoV-2 diagnosis, some of them with emergency use authorization (EUA) by the Food Drug Administration (FDA) or their country of origin agency, but also many of them without any independent clinical performance evaluation. We performed a clinical evaluation for two Chinese SARS-CoV-2 RT-PCR kits available in South America, COVID-19 Nucleic Acid Test Kit (eDiagnosis Biomedicine, Wuhan, China) and 2019-nCoV Nucleic Acid Diagnostic Kit (Sansure Biotech, Changsha, China), for RT-qPCR SARS-CoV-2 diagnosis using the FDA EUA 2019-nCoV CDC kit (IDT, Coralville, IA) as gold standard. We found an excellent clinical performance and analytical sensitivity for both kits with sensitivity values of 100% and 95.3% and estimated limit of detection of 500 copies/mL and 1,000 copies/mL, for eDiagnosis and Sansure Biotech kits, respectively. COVID-19 Nucleic Acid Test Kit (eDiagnosis) and 2019-nCoV Nucleic Acid Diagnostic Kit (Sansure Biotech) are both made in China and hold EUA by the Chinese CDC. Also, Sansure Biotech kit has EUA by the FDA. In conclusion, our results endorse the use of these two commercially available kits imported to Ecuador for SARS-CoV-2 diagnosis, as they had the similar clinical performance as the gold standard from the CDC.

Gender differences in treatment of Coronavirus Disease-2019

Coronavirus Disease-2019 (COVID-19) is the worst worldwide pandemic with more than 12,000,000 cases and 560,000 deaths until 14th July 2020. Men were more infected by COVID-19 than women, and male subjects with underlying conditions, including diabetes, hypertension, and cardiovascular diseases developed a severe form of the affection, with increased mortality rate. Many factors can contribute to the disparity in disease outcomes, such as hormone-specific reaction and activity of X-linked genes, which modulate the innate and adaptive immune response to virus infection. Until now, only the Remdesivir was approved by FDA (Food Drug Administration) for COVID-19 treatment, although several clinical trials are ongoing worldwide also on other drugs. In this review, we analyzed published studies on several drugs (chloroquine or hydroxychloroquine, remdesivir, favipiravir, lopinavir-ritonavir in combination, tocilizumab, plasma, and immunoglobulins) with some efficacy to COVID-19 in humans, and evaluated if there were a gender analysis of the available data. In our opinion, it is essential to report data about COVID-19 disaggregated by sex, age, and race, because the knowledge of gender differences is fundamental to identify effective and customized treatments to reduce hospitalizations, admissions to intensive care units, and mortality.

Azelaic Acid: A Promising Agent for Dermatological Applications

Azelaic Acid (AA) is a naturally occurring 9-carbon straight-chain saturated dicarboxylic acid widely found in wheat, rye, and barley. It has been shown to possess numerous biochemical activities, such as anti-inflammatory, anti-microbial, antioxidant, anticomedolytic and anticancer. This therapeutic agent has been approved by US food Drug Administration for the treatment of mild to moderate acne and rosacea. Further, azelaic acid has been reported for the management of skin hyperpigmentation, melasma and alopecia. In this review article, several studies on azelaic acid that pointed out its bioactivities and pharmacology along with its drug delivery systems are reviewed. Additionally, an outlook on its mechanism of action is also given. Azelaic acid is an important moiety for the management of acne owing to its benefits in addressing follicular excess sebum, inflammatory action, hyperproliferation and activity against Propionibacterium acne. The commercially available topical formulations normally contain 15 to 20% AA. In the future, a broadspectrum antibacterial agent, azelaic acid can act as a pillar in acne therapy minimizing the potential risk of emergence of resistance. This review will definitely provide a new perspective for research involving this bioactive molecule.

Worldwide Crude Death Rate, Case Fatality Rate, and Attack Rate from COVID-19: with up to date Comprehensive Review

This article sheds light on the up to date details of COVID-19 and why it began in Wuhan. Further, it discusses the available treatment options and their effects on patients with COVID-19, and which drugs patients and clinicians should avoid. It elucidates the common signs and symptoms and the stages of the severity of patients' condition with COVID-19, including its definition, according to the World Health Organization (WHO). It shows possible ways to break up the transmission mechanism by giving a simple table with a clear and concise caption for each point. Moreover, it announces three ways to diagnose COVID-19, including the latest five-minutes test that was approved by the US Food Drug Administration (FDA) on March 28, 2020. It also elaborates on the main features that can be found on the Chest Computed Tomography Scan (CT-scan) and its four stages. This article will show the difference between previous similar virus attacks like Severe Acute Respiratory Syndrome (SARS) and Middle Eastern Respiratory Syndrome (MERS). It talks briefly about children and pregnant women with COVID. It shows the latest toll of death from COVID-19 and the number of new cases for several countries.

Upcoming Drifts In Bio-Similars

Background: Biopharmaceuticals such as Biologic medicinal products have been in clinical use over the past three decades and have benefited towards the therapy of degenerative and critical metabolic diseases. It is forecasted that market of biologics will be going to increase at a rate of 20% per year, and by 2025, more than ˃ 50% of new drug approvals may be biological products. The increasing utilization of the biologics necessitates for cost control, especially for innovators products that have enjoyed a lengthy period of exclusive use. As the first wave of biopharmaceuticals is expired or set to expire, it has led to various opportunities for the expansion of bio-similars i.e. copied versions of original biologics with same biologic activity. Development of biosimilars is expected to promote market competition, meet worldwide demand, sustain the healthcare systems and maintain the incentives for innovation. Methods: Appraisal of published articles from peer reviewed journals, PubMed literature, latest news and guidelines from European Medicine Agency, US Food Drug Administration (FDA) and India are used to identify data for review. Results: Main insight into the quality requirements concerning biologics, current status of regulation of biosimilars and upcoming challenges lying ahead for the upgrading of marketing authorization of bio-similars has been incorporated. Compiled literature on therapeutic status, regulatory guidelines and the emerging trends and opportunities of biosimilars has been thoroughly stated. Conclusion: Updates on biosimilars will support to investigate the possible impact of bio-similars on healthcare market.

The Neurokinins: Peptidomimetic Ligand Design and Therapeutic Applications

The neurokinins are indisputably essential neurotransmitters in numerous pathoand physiological events. Being widely distributed in the Central Nervous System (CNS) and peripheral tissues, their discovery rapidly promoted them to drugs targets. As a necessity for molecular tools to understand the biological role of this class, endogenous peptides and their receptors prompted the scientific community to design ligands displaying either agonist and antagonist activity at the three main neurokinin receptors, called NK1, NK2 and NK3. Several strategies were implemented for this purpose. With a preference to small non-peptidic ligands, many research groups invested efforts in synthesizing and evaluating a wide range of scaffolds, but only the NK1 antagonist Aprepitant (EMENDT) and its prodrug Fosaprepitant (IVEMENDT) have been approved by the Food Drug Administration (FDA) for the treatment of Chemotherapy-Induced and Post-Operative Nausea and Vomiting (CINV and PONV, respectively). While non-peptidic drugs showed limitations, especially in side effect control, peptidic and pseudopeptidic compounds progressively regained attention. Various strategies were implemented to modulate affinity, selectivity and activity of the newly designed ligands. Replacement of canonical amino acids, incorporation of conformational constraints, and fusion with non-peptidic moieties gave rise to families of ligands displaying individual or dual NK1, NK2 and NK3 antagonism, that ultimately were combined with non-neurokinin ligands (such as opioids) to target enhanced biological impact.

Liposome Drug Delivery in Cancer Chemotherapy: Review and Multifactorial Analysis

We reviewed the use of liposomes for cancer therapy using computational biostatistics. We used virtual libraries, such as PubMed, LILACS, National Health Institute (NHI) and the Food Drug Administration (FDA) to conduct the review. Cluster analysis and correlation were developed using the Tanimoto coefficient (TC) of 0.7 using the modeling tool ChemMine Tools from databases (PubChem, DailyMed, DrugBank, Drug @ FDA). The results pointed fifteen molecules in the pharmaceutical form of liposome for the oncological clinic. Of these, 13 are classified by size into small-molecules and were analyzed by computational statistical modeling. Of these, only 4 were approved for use by the FDA, and 9 are in phases of research by the pharmaceutical industry as liposomal formulations. Essential differences in physical-chemical properties and molecules structure were observed, indicating original proposal in the development of liposomal as an anticancer drugs.