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1.
MMWR Morb Mortal Wkly Rep ; 70(37): 1306-1311, 2021 Sep 17.
Artigo em Inglês | MEDLINE | ID: mdl-34529645

RESUMO

Data from randomized clinical trials and real-world observational studies show that all three COVID-19 vaccines currently authorized for emergency use by the Food and Drug Administration* are safe and highly effective for preventing COVID-19-related serious illness, hospitalization, and death (1,2). Studies of vaccine effectiveness (VE) for preventing new infections and hospitalizations attributable to SARS-CoV-2, the virus that causes COVID-19), particularly as the B.1.617.2 (Delta) variant has become predominant, are limited in the United States (3). In this study, the New York State Department of Health linked statewide immunization, laboratory testing, and hospitalization databases for New York to estimate rates of new laboratory-confirmed COVID-19 cases and hospitalizations by vaccination status among adults, as well as corresponding VE for full vaccination in the population, across all three authorized vaccine products. During May 3-July 25, 2021, the overall age-adjusted VE against new COVID-19 cases for all adults declined from 91.8% to 75.0%. During the same period, the overall age-adjusted VE against hospitalization was relatively stable, ranging from 89.5% to 95.1%. Currently authorized vaccines have high effectiveness against COVID-19 hospitalization, but effectiveness against new cases appears to have declined in recent months, coinciding with the Delta variant's increase from <2% to >80% in the U.S. region that includes New York and relaxation of masking and physical distancing recommendations. To reduce new COVID-19 cases and hospitalizations, these findings support the implementation of a layered approach centered on vaccination, as well as other prevention strategies such as masking and physical distancing.


Assuntos
Vacinas contra COVID-19/administração & dosagem , COVID-19/diagnóstico , COVID-19/terapia , Hospitalização/estatística & dados numéricos , Vacinação/estatística & dados numéricos , Adolescente , Adulto , Idoso , COVID-19/epidemiologia , COVID-19/prevenção & controle , Técnicas de Laboratório Clínico , Humanos , Pessoa de Meia-Idade , New York/epidemiologia , SARS-CoV-2/isolamento & purificação , Adulto Jovem
2.
MMWR Morb Mortal Wkly Rep ; 70(34): 1150-1155, 2021 Aug 27.
Artigo em Inglês | MEDLINE | ID: mdl-34437517

RESUMO

Data from randomized clinical trials and real-world observational studies show that all three COVID-19 vaccines currently authorized for emergency use by the Food and Drug Administration* are safe and highly effective for preventing COVID-19-related serious illness, hospitalization, and death (1,2). Studies of vaccine effectiveness (VE) for preventing new infections and hospitalizations attributable to SARS-CoV-2, the virus that causes COVID-19), particularly as the B.1.617.2 (Delta) variant has become predominant, are limited in the United States (3). In this study, the New York State Department of Health linked statewide immunization, laboratory testing, and hospitalization databases for New York to estimate rates of new laboratory-confirmed COVID-19 cases and hospitalizations by vaccination status among adults, as well as corresponding VE for full vaccination in the population, across all three authorized vaccine products. During May 3-July 25, 2021, the overall age-adjusted VE against new COVID-19 cases for all adults declined from 91.7% to 79.8%. During the same period, the overall age-adjusted VE against hospitalization was relatively stable, ranging from 91.9% to 95.3%. Currently authorized vaccines have high effectiveness against COVID-19 hospitalization, but effectiveness against new cases appears to have declined in recent months, coinciding with the Delta variant's increase from <2% to >80% in the U.S. region that includes New York and relaxation of masking and physical distancing recommendations. To reduce new COVID-19 cases and hospitalizations, these findings support the implementation of a layered approach centered on vaccination, as well as other prevention strategies such as masking and physical distancing.


Assuntos
Vacinas contra COVID-19/administração & dosagem , COVID-19/diagnóstico , COVID-19/terapia , Hospitalização/estatística & dados numéricos , Vacinação/estatística & dados numéricos , Adolescente , Adulto , Idoso , COVID-19/epidemiologia , COVID-19/prevenção & controle , Técnicas de Laboratório Clínico , Humanos , Pessoa de Meia-Idade , New York/epidemiologia , SARS-CoV-2/isolamento & purificação , Adulto Jovem
3.
J Trop Pediatr ; 67(3)2021 07 02.
Artigo em Inglês | MEDLINE | ID: mdl-34363077

RESUMO

BACKGROUND: Most studies on gastroenteritis have focused on viral and bacterial infections, while gastroenteritis where intestinal protozoan parasites may have played a role has not been well studied. This study was therefore, designed to assess the frequency and several potential risk factors for Cryptosporidium infection among children suffering from acute gastroenteritis and presented to a tertiary hospital in Cairo, Egypt. Effectiveness of modified Ziehl-Neelsen (MZN) and nested polymerase chain reaction (nPCR) for Cryptosporidium detection were evaluated as well. METHODS: A cross-sectional study was performed during the period from July 2018 to December 2018, where 100 human diarrheic stool samples were collected from children aged 3 months up to 12 years old presented to Ain Shams University Pediatrics Hospital, Cairo, Egypt with acute gastroenteritis. Demographic and clinical data were obtained from the participants. Initial parasite screening was done using the MZN staining method, and microscopically examined for Cryptosporidium infection, while genotyping was based on molecular diagnostic assays using nPCR and sequencing for selected samples. RESULTS: The overall frequency of Cryptosporidium infection was 5% using light microscopy, while 19% of samples were positive by nPCR. Cryptosporidium hominis was the only detected genotype. Clinical picture among cases were not significant in comparison to patients with other causes of gastroenteritis. CONCLUSION: Cryptosporidium infection is more common below 5 years of age; however, clinical data are not enough for suspicion of infection. Nucleic acid-based methods are more sensitive and specific despite the high cost in developing countries. However, real estimation of Cryptosporidium disease burden is of an outmost importance to achieve prevention and detection of the Cryptosporidium species genetic diversity. Lay summaryCryptosporidium is a protozoan, which causes gastroenteritis in humans. It is most common below 5 years of age; however, diarrhea and vomiting characteristics are not different from other causes of gastroenteritis. General diagnostic methods are inadequate for detection of these infections. Nested polymerase chain reaction (nPCR) and sequencing are accurate methods for pathogen detection and species verification. Our study included 100 Egyptian children with acute gastroenteritis. The overall frequency of Cryptosporidium infection was 5% using light microscopy, while 19% of samples were positive by nPCR. The clinical picture of the children presenting with this disease was not significantly different from those presenting with gastroenteritis due to other causes. This emphasizes the importance of proper diagnosis to know the true burden of the disease.


Assuntos
Criptosporidiose , Cryptosporidium , Gastroenterite , Criança , Técnicas de Laboratório Clínico , Estudos Transversais , Criptosporidiose/diagnóstico , Criptosporidiose/epidemiologia , Cryptosporidium/genética , Diarreia , Egito/epidemiologia , Fezes , Gastroenterite/diagnóstico , Gastroenterite/epidemiologia , Humanos , Centros de Atenção Terciária
4.
Int J Mol Sci ; 22(16)2021 Aug 13.
Artigo em Inglês | MEDLINE | ID: mdl-34445406

RESUMO

The reverse transcription quantitative polymerase chain reaction (RT-qPCR) is an established tool for the diagnosis of RNA pathogens. Its potential for automation has caused it to be used as a presence/absence diagnostic tool even when RNA quantification is not required. This technology has been pushed to the forefront of public awareness by the COVID-19 pandemic, as its global application has enabled rapid and analytically sensitive mass testing, with the first assays targeting three viral genes published within days of the publication of the SARS-CoV-2 genomic sequence. One of those, targeting the RNA-dependent RNA polymerase gene, has been heavily criticised for supposed scientific flaws at the molecular and methodological level, and this criticism has been extrapolated to doubts about the validity of RT-qPCR for COVID-19 testing in general. We have analysed this assay in detail, and our findings reveal some limitations but also highlight the robustness of the RT-qPCR methodology for SARS-CoV-2 detection. Nevertheless, whilst our data show that some errors can be tolerated, it is always prudent to confirm that the primer and probe sequences complement their intended target, since, when errors do occur, they may result in a reduction in the analytical sensitivity. However, in this case, it is unlikely that a mismatch will result in poor specificity or a significant number of false-positive SARS-CoV-2 diagnoses, especially as this is routinely checked by diagnostic laboratories as part of their quality assurance.


Assuntos
Teste para COVID-19/métodos , COVID-19/diagnóstico , Técnicas de Diagnóstico Molecular/métodos , Reação em Cadeia da Polimerase em Tempo Real/métodos , SARS-CoV-2/isolamento & purificação , COVID-19/epidemiologia , COVID-19/virologia , Técnicas de Laboratório Clínico/métodos , Humanos , Pandemias , RNA Viral/genética , RNA Polimerase Dependente de RNA , SARS-CoV-2/genética , Sensibilidade e Especificidade , Temperatura
5.
Microbiol Spectr ; 9(1): e0034221, 2021 09 03.
Artigo em Inglês | MEDLINE | ID: mdl-34346748

RESUMO

As the COVID-19 pandemic progresses, there is an increasing need for rapid, accessible assays for SARS-CoV-2 detection. We present a clinical evaluation and real-world implementation of the INDICAID COVID-19 rapid antigen test (INDICAID rapid test). A multisite clinical evaluation of the INDICAID rapid test using prospectively collected nasal (bilateral anterior) swab samples from symptomatic subjects was performed. The INDICAID rapid test demonstrated a positive percent agreement (PPA) and negative percent agreement (NPA) of 85.3% (95% confidence interval [95% CI], 75.6% to 91.6%) and 94.9% (95% CI, 91.6% to 96.9%), respectively, compared to laboratory-based reverse transcriptase PCR (RT-PCR) using nasal specimens. The INDICAID rapid test was then implemented at COVID-19 outbreak screening centers in Hong Kong as part of a testing algorithm (termed "dual-track") to screen asymptomatic individuals for prioritization for confirmatory RT-PCR testing. In one approach, preliminary positive INDICAID rapid test results triggered expedited processing for laboratory-based RT-PCR, reducing the average time to confirmatory result from 10.85 h to 7.0 h. In a second approach, preliminary positive results triggered subsequent testing with an onsite rapid RT-PCR, reducing the average time to confirmatory result to 0.84 h. In 22,994 asymptomatic patients, the INDICAID rapid test demonstrated a PPA of 84.2% (95% CI, 69.6% to 92.6%) and an NPA of 99.9% (95% CI, 99.9% to 100%) compared to laboratory-based RT-PCR using combined nasal/oropharyngeal specimens. The INDICAID rapid test has excellent performance compared to laboratory-based RT-PCR testing and, when used in tandem with RT-PCR, reduces the time to confirmatory positive result. IMPORTANCE Laboratory-based RT-PCR, the current gold standard for COVID-19 testing, can require a turnaround time of 24 to 48 h from sample collection to result. The delayed time to result limits the effectiveness of centralized RT-PCR testing to reduce transmission and stem potential outbreaks. To address this, we conducted a thorough evaluation of the INDICAID COVID-19 rapid antigen test, a 20-minute rapid antigen test, in both symptomatic and asymptomatic populations. The INDICAID rapid test demonstrated high sensitivity and specificity with RT-PCR as the comparator method. A dual-track testing algorithm was also evaluated utilizing the INDICAID rapid test to screen for preliminary positive patients, whose samples were then prioritized for RT-PCR testing. The dual-track method demonstrated significant improvements in expediting the reporting of positive RT-PCR test results compared to standard RT-PCR testing without prioritization, offering an improved strategy for community testing and controlling SARS-CoV-2 outbreaks.


Assuntos
Antígenos Virais/análise , Doenças Assintomáticas , Teste para COVID-19/métodos , COVID-19/diagnóstico , COVID-19/imunologia , SARS-CoV-2/isolamento & purificação , Adulto , Técnicas de Laboratório Clínico/métodos , Reações Falso-Negativas , Reações Falso-Positivas , Feminino , Hong Kong , Humanos , Masculino , Programas de Rastreamento/métodos , Pessoa de Meia-Idade , Pandemias , Reação em Cadeia da Polimerase , SARS-CoV-2/genética , Sensibilidade e Especificidade , Manejo de Espécimes , Fatores de Tempo , Adulto Jovem
6.
Microbiol Spectr ; 9(1): e0031221, 2021 09 03.
Artigo em Inglês | MEDLINE | ID: mdl-34378949

RESUMO

Pooled testing for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) detection is instrumental for increasing test capacity while decreasing test cost. Pooled testing programs permit sustainable, long-term surveillance measures, which are essential for the early detection of virus resurgence in communities or the emergence of variants of concern. While numerous pooled approaches have been proposed to increase test capacity, uptake by laboratories has been limited. On 9 December 2020, we invited 362 U.S. laboratories that inquired about the Yale School of Public Health SalivaDirect test to participate in a survey to evaluate testing constraints and pooling strategies for SARS-CoV-2 testing. The survey was distributed using Qualtrics, and three reminders were sent. The survey closed on 21 January 2021. Of 93 responses received (25.7% response rate), 90 were from Clinical Laboratory Improvement Amendments (CLIA)-certified laboratories conducting SARS-CoV-2 testing. The remaining three were excluded from the analyses. Responses indicated that the major barriers to the uptake of pooled testing in the United States may not simply be the number of tests a laboratory can process per day, but rather the lack of clear protocols and adequate resources; laboratories are working with fixed physical and human capital constraints. Importantly, laboratories across the country are heterogeneous in infrastructure and workflow. The need for SARS-CoV-2 testing will remain for years to come. Testing programs can be maintained through pooled PCR testing strategies, and while statisticians, operations researchers, and others with expertise in sampling design have important value to add, laboratories require support on how to transition from traditional diagnostic testing to pooled surveillance. IMPORTANCE While numerous pooled SARS-CoV-2 testing approaches have been described in an effort to increase testing capacity and decrease test prices, uptake by laboratories has been limited. Responses to our survey of United States-based laboratories highlight the importance of consulting end-users-those that solutions are being designed for-so challenges can be addressed in a manner tailored to meet the specific needs out in the field. It may be surprising to those designing pooled testing strategies to learn that laboratories view pooling as more time-consuming than testing samples individually, and therefore that it is thought to create delays in test reporting.


Assuntos
Teste para COVID-19/métodos , Teste para COVID-19/estatística & dados numéricos , COVID-19/diagnóstico , Teste para COVID-19/normas , Técnicas de Laboratório Clínico/métodos , Testes Diagnósticos de Rotina , Humanos , Laboratórios/estatística & dados numéricos , RNA Viral , SARS-CoV-2/genética , SARS-CoV-2/isolamento & purificação , Manejo de Espécimes , Tempo , Estados Unidos
7.
FEMS Microbiol Lett ; 368(16)2021 Aug 26.
Artigo em Inglês | MEDLINE | ID: mdl-34410377

RESUMO

The COVID-19 (coronavirus disease 2019) pandemic has forced universities to find new ways to conduct learning and teaching, as traditional face-to-face teaching has been prevented or restricted to an absolute minimum in many instances. Therefore, we redesigned and taught second-year veterinary student microbiology laboratory exercises (labs) with a hybrid learning approach. For this, a novel 'remote partner' model was implemented in which students present on-site in the laboratory worked synchronously pairwise with their remote partner present online. A student feedback survey revealed that in this remote partner model, both on-site and online participation in the labs were experienced as being useful in improving their laboratory skills. The students' overall performance in hands-on microbiological laboratory skills and safe working practices was similar in the hybrid learning approach (the 2021 class) and in the traditional on-site participation approach (the 2018-20 classes). This study suggests that the remote partner model is an effective way to acquire microbiological laboratory skills. This learning approach can be used in the non-pandemic future and/or also be applied to other fields.


Assuntos
COVID-19/epidemiologia , Educação à Distância/métodos , Educação em Veterinária/métodos , Microbiologia/educação , COVID-19/prevenção & controle , Técnicas de Laboratório Clínico , Educação à Distância/organização & administração , Educação em Veterinária/organização & administração , Avaliação Educacional , Humanos , Modelos Educacionais , Ensino
8.
AANA J ; 89(4): 281-282, 2021 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-34342564

RESUMO

In a series of commentaries in recent issues of the New England Journal of Medicine, potential bias in pulse oximetry has been questioned.


Assuntos
Técnicas de Laboratório Clínico/normas , Guias como Assunto , Oximetria/normas , Racismo , Humanos , Estados Unidos
9.
Artigo em Inglês | MEDLINE | ID: mdl-34205104

RESUMO

Acute febrile illnesses occur frequently in Guinea. Acute fever itself is not a unique, hallmark indication (pathognomonic sign) of any one illness or disease. In the infectious disease context, fever's underlying cause can be a wide range of viral or bacterial pathogens, including the Ebola virus. In this study, molecular and serological methods were used to analyze samples from patients hospitalized with acute febrile illness in various regions of Guinea. This analysis was undertaken with the goal of accomplishing differential diagnosis (determination of causative pathogen) in such cases. As a result, a number of pathogens, both viral and bacterial, were identified in Guinea as causative agents behind acute febrile illness. In approximately 60% of the studied samples, however, a definitive determination could not be made.


Assuntos
Técnicas de Laboratório Clínico , Febre , Diagnóstico Diferencial , Febre/diagnóstico , Febre/etiologia , Guiné/epidemiologia , Humanos
10.
Emerg Med Clin North Am ; 39(3): 605-625, 2021 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-34215405

RESUMO

Encountering a child with congenital heart disease after surgical palliation in the emergency department, specifically the single-ventricle or ventricular assist device, without a basic familiarity of these surgeries can be extremely anxiety provoking. Knowing what common conditions or complications may cause these children to visit the emergency department and how to stabilize will improve the chance for survival and is the premise for this article, regardless of practice setting.


Assuntos
Parada Cardíaca/terapia , Cardiopatias Congênitas/cirurgia , Medicina de Emergência Pediátrica , Choque Cardiogênico/terapia , Manuseio das Vias Aéreas , Algoritmos , Reanimação Cardiopulmonar , Procedimentos Cirúrgicos Cardiovasculares , Criança , Técnicas de Laboratório Clínico , Contraindicações de Medicamentos , Diagnóstico por Imagem , Serviço Hospitalar de Emergência , Coração Auxiliar , Humanos , Cuidados Paliativos
11.
Viruses ; 13(6)2021 06 01.
Artigo em Inglês | MEDLINE | ID: mdl-34205940

RESUMO

In recent weeks, adverse reactions have been reported after administration of Oxford-AstraZeneca chimpanzee adenovirus vectored vaccine ChAdOx1 nCoV-19 (AZD1222), in particular thrombus formation, which has led several European Countries to discontinue administration of this vaccine. On March 8, 2021, the European Medicines Agency Safety Committee did not confirm this probable association. We report the case of a patient who developed disseminated intravascular coagulation after the first dose of Oxford-Astra Zeneca vaccine, which resolved in a few days with the administration of dexamethasone and enoxaparin. This work demonstrates the safety of the Oxford-Astra Zeneca vaccine and that any development of side effects can be easily managed with a prompt diagnosis and in a short time with a few commonly used drugs.


Assuntos
Vacinas contra COVID-19/efeitos adversos , COVID-19/prevenção & controle , Coagulação Intravascular Disseminada/diagnóstico , Coagulação Intravascular Disseminada/etiologia , COVID-19/imunologia , Técnicas de Laboratório Clínico , Dexametasona/uso terapêutico , Coagulação Intravascular Disseminada/tratamento farmacológico , Enoxaparina/uso terapêutico , Feminino , Humanos , Pessoa de Meia-Idade , SARS-CoV-2/imunologia , Vacinação
12.
Int J Lab Hematol ; 43 Suppl 1: 65-70, 2021 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-34288450

RESUMO

Anemia is a global health problem in all age groups. According to World Health Organization (WHO), approximately 40% of pregnant women are anemic. Iron deficiency anemia (IDA) due to nutritional deficiency is the most common cause. The incidence of IDA varies worldwide depending on the socioeconomic status, but it remains the leading cause even in developed countries. Physiologic anemia of pregnancy due to relatively higher expansion of blood volume in comparison with elevated red blood cell mass also occurs frequently. Complete blood count (CBC) in the first trimester is recommended for all pregnant women to screen for anemia. The screening of pregnant women for IDA in absence of anemia is still debatable. If IDA is suspected, ferritin level of <30 ng/ml is diagnostic. Iron supplementation is recommended for all pregnant women to compensate the increased demand.


Assuntos
Anemia/diagnóstico , Serviços de Laboratório Clínico , Técnicas de Laboratório Clínico , Complicações Hematológicas na Gravidez/diagnóstico , Anemia/etiologia , Anemia Ferropriva/diagnóstico , Anemia Ferropriva/etiologia , Técnicas de Laboratório Clínico/métodos , Diagnóstico Diferencial , Gerenciamento Clínico , Suscetibilidade a Doenças , Feminino , Humanos , Programas de Rastreamento , Gravidez , Complicações Hematológicas na Gravidez/etiologia
13.
Front Cell Infect Microbiol ; 11: 653616, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34268131

RESUMO

Coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has become a major threat to public health. Rapid molecular testing for convenient and timely diagnosis of SARS-CoV-2 infections represents a challenge that could help to control the current pandemic and prevent future outbreaks. We aimed to develop and validate a multiplex and colorimetric reverse transcription loop-mediated isothermal amplification (RT-LAMP) assay using lyophilized LAMP reagents for sensitive and rapid detection of SARS-CoV-2. LAMP primers were designed for a set of gene targets identified by a genome-wide comparison of viruses. Primer sets that showed optimal features were combined into a multiplex RT-LAMP assay. Analytical validation included assessment of the limit of detection (LoD), intra- and inter-assay precision, and cross-reaction with other respiratory pathogens. Clinical performance compared to that of real-time reverse transcriptase-polymerase chain reaction (RT-qPCR) was assessed using 278 clinical RNA samples isolated from swabs collected from individuals tested for COVID-19. The RT-LAMP assay targeting the RNA-dependent RNA polymerase (RdRp), membrane (M), and ORF1ab genes achieved a comparable LoD (0.65 PFU/mL, CT=34.12) to RT-qPCR and was 10-fold more sensitive than RT-qPCR at detecting viral RNA in clinical samples. Cross-reactivity to other respiratory pathogens was not observed. The multiplex RT-LAMP assay demonstrated a strong robustness and acceptable intra- and inter-assay precision (mean coefficient of variation, 4.75% and 8.30%). Diagnostic sensitivity and specificity values were 100.0% (95% CI: 97.4-100.0%) and 98.6% (95% CI: 94.9-99.8%), respectively, showing high consistency (Cohen's kappa, 0.986; 95% CI: 0.966-1.000; p<0.0001) compared to RT-qPCR. The novel one-step multiplex RT-LAMP assay is storable at room temperature and showed similar diagnostic accuracy to conventional RT-qPCR, while being faster (<45 min), simpler, and cheaper. The new assay could allow reliable and early diagnosis of SARS-CoV-2 infections in primary health care. It may aid large-scale testing in resource-limited settings, especially if it is integrated into a point-of-care diagnostic device.


Assuntos
COVID-19 , SARS-CoV-2 , Teste para COVID-19 , Técnicas de Laboratório Clínico , Colorimetria , Humanos , Técnicas de Diagnóstico Molecular , Técnicas de Amplificação de Ácido Nucleico , RNA Viral/genética , Transcrição Reversa , Sensibilidade e Especificidade
16.
Transl Psychiatry ; 11(1): 380, 2021 07 07.
Artigo em Inglês | MEDLINE | ID: mdl-34234104

RESUMO

Prevention of major depressive disorder (MDD) is a public health priority. Identifying biomarkers of underlying biological processes that contribute to MDD onset may help address this public health need. This prospective cohort study encompassed 383,131 white British participants from the UK Biobank with no prior history of MDD, with replication in 50,759 participants of other ancestries. Leveraging linked inpatient and primary care records, we computed adjusted odds ratios for 5-year MDD incidence among individuals with values below or above the 95% confidence interval (<2.5th or >97.5th percentile) on each of 57 laboratory measures. Sensitivity analyses were performed across multiple percentile thresholds and in comparison to established reference ranges. We found that indicators of liver dysfunction were associated with increased 5-year MDD incidence (even after correction for alcohol use and body mass index): elevated alanine aminotransferase (AOR = 1.35, 95% confidence interval [1.16, 1.58]), aspartate aminotransferase (AOR = 1.39 [1.19, 1.62]), and gamma glutamyltransferase (AOR = 1.52 [1.31, 1.76]) as well as low albumin (AOR = 1.28 [1.09, 1.50]). Similar observations were made with respect to endocrine dysregulation, specifically low insulin-like growth factor 1 (AOR = 1.34 [1.16, 1.55]), low testosterone among males (AOR = 1.60 [1.27, 2.00]), and elevated glycated hemoglobin (HbA1C; AOR = 1.23 [1.05, 1.43]). Markers of renal impairment (i.e. elevated cystatin C, phosphate, and urea) and indicators of anemia and macrocytosis (i.e. red blood cell enlargement) were also associated with MDD incidence. While some immune markers, like elevated white blood cell and neutrophil count, were associated with MDD (AOR = 1.23 [1.07, 1.42]), others, like elevated C-reactive protein, were not (AOR = 1.04 [0.89, 1.22]). The 30 significant associations validated as a group in the multi-ancestry replication cohort (Wilcoxon p = 0.0005), with a median AOR of 1.235. Importantly, all 30 significant associations with extreme laboratory test results were directionally consistent with an increased MDD risk. In sum, markers of liver and kidney dysfunction, growth hormone and testosterone deficiency, innate immunity, anemia, macrocytosis, and insulin resistance were associated with MDD incidence in a large community-based cohort. Our results support a contributory role of diverse biological processes to MDD onset.


Assuntos
Transtorno Depressivo Maior , Bancos de Espécimes Biológicos , Técnicas de Laboratório Clínico , Estudos de Coortes , Transtorno Depressivo Maior/diagnóstico , Transtorno Depressivo Maior/epidemiologia , Humanos , Incidência , Masculino , Estudos Prospectivos , Reino Unido/epidemiologia
17.
Ann Lab Med ; 41(6): 549-558, 2021 Nov 01.
Artigo em Inglês | MEDLINE | ID: mdl-34108282

RESUMO

Antibodies have proven to be central in the development of diagnostic methods over decades, moving from polyclonal antibodies to the milestone development of monoclonal antibodies. Although monoclonal antibodies play a valuable role in diagnosis, their production is technically demanding and can be expensive. The large size of monoclonal antibodies (150 kDa) makes their re-engineering using recombinant methods a challenge. Single-domain antibodies, such as "nanobodies," are a relatively new class of diagnostic probes that originated serendipitously during the assay of camel serum. The immune system of the camelid family (camels, llamas, and alpacas) has evolved uniquely to produce heavy-chain antibodies that contain a single monomeric variable antibody domain in a smaller functional unit of 12-15 kDa. Interestingly, the same biological phenomenon is observed in sharks. Since a single-domain antibody molecule is smaller than a conventional mammalian antibody, recombinant engineering and protein expression in vitro using bacterial production systems are much simpler. The entire gene encoding such an antibody can be cloned and expressed in vitro. Single-domain antibodies are very stable and heat-resistant, and hence do not require cold storage, especially when incorporated into a diagnostic kit. Their simple genetic structure allows easy re-engineering of the protein to introduce new antigen-binding characteristics or attach labels. Here, we review the applications of single-domain antibodies in laboratory diagnosis and discuss the future potential in this area.


Assuntos
Anticorpos de Domínio Único , Animais , Anticorpos Monoclonais , Camelus , Técnicas de Laboratório Clínico , Cadeias Pesadas de Imunoglobulinas , Anticorpos de Domínio Único/genética
18.
BMC Med Inform Decis Mak ; 21(1): 181, 2021 06 06.
Artigo em Inglês | MEDLINE | ID: mdl-34090442

RESUMO

BACKGROUND: In Japan, a multiple-hospital observational database system, the Medical Information Database Network (MID-NET®), was launched for post-marketing drug safety assessments. These assessments will be based on datasets with missing laboratory results. The characteristics of missing data considering hospital differences have not been evaluated. We assessed the missing proportion and the association between missingness and a factor through case studies using a database system, a part of MID-NET®. METHODS: Seven scenarios using laboratory results before the prescription of the assessed drug as baseline covariates and data from 10 hospitals of Tokushukai Medical Group were used. The missing proportion and the association between missingness and patient background were investigated per hospital. The associations were assessed using the log of adjusted odds ratio (log-aOR). Additionally, an ad hoc survey was conducted to explore other factors affecting the missingness. RESULTS: For some laboratory tests, missing proportions varied among hospitals, such as 7.4-44.4% of alkaline phosphatase (ALP) and 8.1-31.2% of triglyceride (TG) among statin users. The association between missingness and affecting factors also differed among hospitals for some factors; example, the log-aOR of hospitalization associated with missingness of TG was - 0.41 (95% CI, - 1.06 to 0.24) in hospital 3 and 1.84 (95% CI, 1.34 to 2.34) in hospital 4. In the ad hoc survey focusing on ALP, hospital-dependent differences in the ordering system settings were observed. CONCLUSIONS: Hospital differences in missing data appeared in some laboratory tests in our multi-hospital observational database, which could be attributed to the affecting factors, including the patient background.


Assuntos
Gerenciamento de Dados , Hospitais , Técnicas de Laboratório Clínico , Bases de Dados Factuais , Humanos , Japão
19.
Mol Cell Probes ; 58: 101744, 2021 08.
Artigo em Inglês | MEDLINE | ID: mdl-34089805

RESUMO

To increase the repertoire of PCR based laboratory developed tests (LDTs) for the detection of SARS-CoV-2, we describe a new multiplex assay (SORP), targeting the SARS-CoV-2's, Spike and ORF8 genes. The widely used human RNaseP internal control was modified to specifically co-amplify the RNaseP mRNA. The SORP triplex assay was tested on a cohort (n = 372; POS = 144/NEG = 228) of nasopharyngeal flocked swab (NPFS) specimens, previously tested for the presence of SARS-CoV-2 using a PCR assay targeting E and RdRp genes. The overall sensitivity and specificity of the SORP assay was: 99.31% (95% CI: 96.22-99.98%), 100.0% (95% CI: 98.4-100%) respectively. The SORP assay could also detect a panel of variants of concern (VOC) from the B1.1.7 (UK) and B1.351 (SA) lineage. In summary, access to a repertoire of new SARS-CoV-2 LDT's would assist diagnostic laboratories in developing strategies to overcome some of the testing issues encountered during high-throughput SARS-CoV-2 testing.


Assuntos
Teste para COVID-19/métodos , COVID-19/diagnóstico , Técnicas de Laboratório Clínico/métodos , Reação em Cadeia da Polimerase Multiplex/métodos , Reação em Cadeia da Polimerase Via Transcriptase Reversa/métodos , SARS-CoV-2/genética , COVID-19/virologia , Primers do DNA/genética , Sondas de DNA/genética , Humanos , Técnicas de Diagnóstico Molecular/métodos , Reprodutibilidade dos Testes , Ribonuclease P/genética , SARS-CoV-2/fisiologia , Sensibilidade e Especificidade , Glicoproteína da Espícula de Coronavírus/genética , Proteínas Virais/genética
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