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1.
; Fiocruz.
Recurso na Internet em Português | LIS - Localizador de Informação em Saúde | ID: lis-LISBR1.1-47052

RESUMO

A Fundação Oswaldo Cruz (Fiocruz) inicia a produção de protótipos de kits com insumos para a realização de 30 mil testes diagnósticos para o novo coronavírus


Assuntos
Infecções por Coronavirus/diagnóstico , Kit de Reagentes para Diagnóstico/normas , Brasil/epidemiologia
2.
BMJ ; 368: m322, 2020 02 26.
Artigo em Inglês | MEDLINE | ID: mdl-32102782

RESUMO

OBJECTIVE: To evaluate the effectiveness and cost effectiveness of a complex intervention in primary care that aims to increase uptake of hepatitis C virus (HCV) case finding and treatment. DESIGN: Pragmatic, two armed, practice level, cluster randomised controlled trial and economic evaluation. SETTING AND PARTICIPANTS: 45 general practices in South West England (22 randomised to intervention and 23 to control arm). Outcome data were collected from all intervention practices and 21/23 control practices. Total number of flagged patients was 24 473 (about 5% of practice list). INTERVENTION: Electronic algorithm and flag on practice systems identifying patients with HCV risk markers (such as history of opioid dependence or HCV tests with no evidence of referral to hepatology), staff educational training in HCV, and practice posters/leaflets to increase patients' awareness. Flagged patients were invited by letter for an HCV test (with one follow-up) and had on-screen pop-ups to encourage opportunistic testing. The intervention lasted one year, with practices recruited April to December 2016. MAIN OUTCOME MEASURES: Primary outcome: uptake of HCV testing. SECONDARY OUTCOMES: number of positive HCV tests and yield (proportion HCV positive); HCV treatment assessment at hepatology; cost effectiveness. RESULTS: Baseline HCV testing of flagged patients (six months before study start) was 608/13 097 (4.6%) in intervention practices and 380/11 376 (3.3%) in control practices. During the study 2071 (16%) of flagged patients in the intervention practices and 1163 (10%) in control practices were tested for HCV: overall intervention effect as an adjusted rate ratio of 1.59 (95% confidence interval 1.21 to 2.08; P<0.001). HCV antibodies were detected in 129 patients from intervention practices and 51 patients from control practices (adjusted rate ratio 2.24, 1.47 to 3.42) with weak evidence of an increase in yield (6.2% v 4.4%; adjusted risk ratio 1.40, 0.99 to 1.95). Referral and assessment increased in intervention practices compared with control practices (adjusted rate ratio 5.78, 1.6 to 21.6) with a risk difference of 1.3 per 1000 and a "number needed to help" of one extra HCV diagnosis, referral, and assessment per 792 (95% confidence interval 558 to 1883) patients flagged. The average cost of HCV case finding was £4.03 (95% confidence interval £2.27 to £5.80) per at risk patient and £3165 per additional patient assessed at hepatology. The incremental cost effectiveness ratio was £6212 per quality adjusted life year (QALY), with 92.5% probability of being below £20 000 per QALY. CONCLUSION: HepCATT had a modest impact but is a low cost intervention that merits optimisation and implementation as part of an NHS strategy to increase HCV testing and treatment. TRIAL REGISTRATION: ISRCTN61788850.


Assuntos
Hepacivirus/isolamento & purificação , Hepatite C/diagnóstico , Atenção Primária à Saúde/economia , Antivirais/uso terapêutico , Análise Custo-Benefício , Inglaterra , Hepatite C/tratamento farmacológico , Hepatite C/economia , Hepatite C/virologia , Humanos , Kit de Reagentes para Diagnóstico/economia , Kit de Reagentes para Diagnóstico/provisão & distribução , Medicina Estatal
3.
J Med Microbiol ; 69(2): 244-248, 2020 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-31958047

RESUMO

Introduction. Mycoplasma genitalium is a sexually transmitted organism with high levels of resistance to the recommended first-line therapy, azithromycin. The ResistancePlus MG test concurrently detects M. genitalium, and the presence of macrolide-resistance mutations (MRM). European, UK and Australian guidelines recommend a diagnostic test that reports MRM to optimize treatment through resistance-guided therapy. Hence, for samples collected for use on other platforms, reflex testing using the ResistancePlus MG test would be beneficial.Aim. To validate the ResistancePlus MG assay using samples collected in Aptima buffer for testing on the Hologic Panther.Methodology. Positive (n=99) and negative (n=229) clinical samples collected in Aptima buffer were extracted on the MagNA Pure 96 (Roche Diagnostics), and tested with the ResistancePlus MG test on the LightCycler 480 II (Roche Diagnostics). Results were compared to matched samples collected using standard sample collection (urine or swab resuspended in PBS), with positive percent agreement (PPA), negative percent agreement (NPA) and Cohen's Kappa statistic.Results. The ResistancePlus MG test had high performance with a 200 µl input volume (PPA/NPA for M. genitalium detection, 92.9 % [95 % confidence interval (CI): 85.5-96.9]/100 % [95 % CI: 97.9-100], MRM detection, 96.9 % [95 % CI: 88.2-99.5]/85.7 % [95 % CI: 66.4-95.3]) and for 1 ml input volume (PPA/NPA for M. genitalium detection, 95.9%/96.6%, MRM detection, 98.4%/90.3%). Samples remained positive after storage at room temperature beyond the manufacturer-recommended storage of <60 days (mean storage time for 1 ml extraction: 129 days).Conclusion. Samples collected using Aptima collection kits are suitable for reflex testing using the ResistancePlus MG test, allowing detection of macrolide resistance.


Assuntos
Antibacterianos/farmacologia , Testes Diagnósticos de Rotina/métodos , Farmacorresistência Bacteriana , Infecções por Mycoplasma/microbiologia , Mycoplasma genitalium/efeitos dos fármacos , Mycoplasma genitalium/isolamento & purificação , Austrália , Testes Diagnósticos de Rotina/instrumentação , Humanos , Macrolídeos/farmacologia , Infecções por Mycoplasma/diagnóstico , Mycoplasma genitalium/genética , Kit de Reagentes para Diagnóstico , Manejo de Espécimes
4.
Rev Soc Bras Med Trop ; 53: e20190117, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-31994656

RESUMO

INTRODUCTION: This study intends to describe a HIV intake screening strategy in recently incarcerated adults in Distrito Federal, Brasilia, Brazil. METHODS: We tested 455 recently incarcerated adults in Distrito Federal in 2016 using rapid tests (RT) applied to oral samples (OS). RESULTS: The estimated frequency of positive tests was 0.88% (95% confidence interval [CI] 0.34% to 2.24%). CONCLUSIONS: The present findings reveal the potential significance of detecting new HIV infection cases in a vulnerable population using point-of-care rapid diagnostic tests.


Assuntos
Infecções por HIV/diagnóstico , Prisioneiros/estatística & dados numéricos , Adolescente , Adulto , Brasil/epidemiologia , Feminino , Infecções por HIV/epidemiologia , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Prevalência , Kit de Reagentes para Diagnóstico , Adulto Jovem
5.
Ann Lab Med ; 40(1): 33-39, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31432637

RESUMO

BACKGROUND: The interferon-gamma (IFN-γ) releasing assay (IGRA) is widely used for latent tuberculosis infection (LTBI) diagnosis. We evaluated the analytical performance of a new automated chemiluminescent immunoanalyzer-based IGRA (CLIA-IGRA), AdvanSure I3 (LG Life Sciences, Seoul, Korea) and compared it with that of the QuantiFERON-TB Gold In-Tube (QFT-GIT) assay. METHODS: Repeatability and reproducibility were evaluated at four levels. Detection capability, including limit of blank (LoB), limit of detection (LoD), and limit of quantification (LoQ), was evaluated using IFN-γ standard material (National Institute for Biological Standards and Control code: 87/586). Agreement between the results of two assays was evaluated using 341 blood samples from healthcare workers and patients at a tertiary care hospital. To determine the cut-off value of CLIA-IGRA for diagnosing LTBI, the ROC curve was analyzed. RESULTS: Repeatability and reproducibility were 4.86-7.00% and 6.36-7.88% CV, respectively. LoB, LoD, and LoQ were 0.022, 0.077, and 0.249 IU/mL, respectively. IFN-γ values between CLIA-IGRA and QFT-GIT showed a strong correlation within the analytical measurable range of both assays, especially when the value was low. Qualitative comparison of the two assays yielded a 99.1% overall agreement (kappa coefficient=0.98). A cut-off value of 0.35 IU/mL was appropriate for diagnosing LTBI. CONCLUSIONS: CLIA-IGRA is a reliable assay for LTBI diagnosis, with performance similar to that of QFT-GIT.


Assuntos
Testes de Liberação de Interferon-gama/métodos , Interferon gama/sangue , Área Sob a Curva , Automação , Humanos , Imunoensaio , Tuberculose Latente/diagnóstico , Limite de Detecção , Medições Luminescentes , Curva ROC , Kit de Reagentes para Diagnóstico , Reprodutibilidade dos Testes , República da Coreia , Centros de Atenção Terciária
6.
Ann Lab Med ; 40(1): 57-62, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31432640

RESUMO

As various linezolid resistance mechanisms have been identified in methicillin-resistant Staphylococcus aureus (MRSA), we investigated the molecular characteristics of MRSA with elevated linezolid minimum inhibitory concentrations (MICs), using the VITEK 2 system (bioMérieux, Marcy-l'Étoile, France). Twenty-seven MRSA isolates from 14 patients exhibiting linezolid MICs ≥8 µg/mL were examined by broth microdilution (BMD) test as well as by sequencing for mutations in the 23S rRNA gene or ribosomal proteins (L3, L4, and L22) and the presence of the optrA, cfr, and cfr(B) genes. Of the 27 isolates, four (14.8%) from one patient were confirmed as linezolid resistant by BMD and harbored a 23S rRNA T2500A mutation. The remaining 23 were confirmed as linezolid susceptible, indicating that the linezolid-resistant results were major errors generated by VITEK 2. The most commonly detected mutation (19/27, 70.4%), L3 Gly152Asp, was detected in only linezolid-susceptible isolates. No isolates contained optrA, cfr, or cfr(B) or any L4 or L22 protein alterations. Our results show that the 23S rRNA T2500A mutation was mainly associated with linezolid resistance, while the L3 Gly152Asp mutation was not related to linezolid resistance. A confirmatory test is recommended for VITEK 2 linezolid-resistant results owing to the high probability of false resistant results.


Assuntos
Farmacorresistência Bacteriana/genética , Linezolida/farmacologia , Staphylococcus aureus Resistente à Meticilina/efeitos dos fármacos , Testes de Sensibilidade Microbiana/métodos , Reações Falso-Positivas , Humanos , Staphylococcus aureus Resistente à Meticilina/genética , Staphylococcus aureus Resistente à Meticilina/isolamento & purificação , Mutação Puntual , RNA Ribossômico 23S/genética , Kit de Reagentes para Diagnóstico , República da Coreia , Proteínas Ribossômicas/genética
7.
Ann Lab Med ; 40(1): 72-75, 2020 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-31432643

RESUMO

Accurate detection of BCR-ABL fusion transcripts at and below molecular response (MR) 4 (0.01% International Scale [IS]) is required for disease monitoring in patients with chronic myeloid leukemia (CML). We evaluated the analytical performance of the QXDx BCR-ABL %IS (Bio-Rad, Hercules, CA, USA) droplet digital PCR (ddPCR) assay, which is the first commercially available ddPCR-based in vitro diagnostics product. In precision analysis, the %CV was 9.3% and 3.0%, with mean values of 0.031% IS and 9.4% IS, respectively. The assay was linear in the first order, ranging from 0.032% IS to 20% IS. The manufacturer-claimed limit of blank, limit of detection, and limit of quantification were verified successfully. There was a very strong correlation between the results of the QXDx BCR-ABL %IS ddPCR assay and the ipsogen BCR-ABL1 Mbcr IS-MMR (Qiagen, Hilden, Germany) real-time quantitative PCR assay (r=0.996). In conclusion, the QXDx BCR-ABL %IS ddPCR assay can provide reliable results for CML patients.


Assuntos
Proteínas de Fusão bcr-abl/genética , Leucemia Mielogênica Crônica BCR-ABL Positiva/diagnóstico , Reação em Cadeia da Polimerase/métodos , DNA de Neoplasias/genética , DNA de Neoplasias/metabolismo , Humanos , Limite de Detecção , Kit de Reagentes para Diagnóstico
9.
Ann Lab Med ; 40(2): 169-173, 2020 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-31650734

RESUMO

The GENEDIA MTB/NTM Detection Kit (GENEDIA MTB/NTM; Green Cross Medical Science Corp., Chungbuk, Korea) is a multiplex real-time PCR assay used for differential identification of Mycobacterium tuberculosis complex (MTBC) and nontuberculous mycobacteria (NTM). While the importance of differential identification of MTB/NTM is recognized, there is limited data on the performance of GENEDIA MTB/NTM assay to date. A total of 687 consecutive sputum specimens were cultured and analyzed with the GENEDIA MTB/NTM and GENEDIA MTB assays. Nineteen specimens (2.8%) were MTBC-positive, and 69 (10.0%) were NTM-positive based on mycobacterial culture. All specimens showed concordant results for MTBC using both assays, with a kappa value of 1.00, overall sensitivity of 63.2% (12/19), and specificity of 100% (668/668). The overall NTM sensitivity and specificity were 23.2% (16/69) and 99.7% (616/618) for GENEDIA MTB/NTM. The association between NTM-positivity using GENEDIA MTB/NTM and the diagnosis of NTM pulmonary disease was not statistically significant. In conclusion, the two real-time PCR assays showed similar diagnostic performance for MTBC detection. However, the sensitivity for NTM detection was lower than that for MTBC detection.


Assuntos
Infecções por Micobactéria não Tuberculosa/diagnóstico , Mycobacterium tuberculosis/genética , Micobactérias não Tuberculosas/genética , Escarro/microbiologia , Tuberculose/diagnóstico , DNA Bacteriano/análise , Humanos , Reação em Cadeia da Polimerase Multiplex , Infecções por Micobactéria não Tuberculosa/microbiologia , Mycobacterium tuberculosis/isolamento & purificação , Micobactérias não Tuberculosas/isolamento & purificação , Kit de Reagentes para Diagnóstico , Sensibilidade e Especificidade , Tuberculose/microbiologia
10.
BMC Infect Dis ; 19(1): 1048, 2019 Dec 11.
Artigo em Inglês | MEDLINE | ID: mdl-31829183

RESUMO

BACKGROUND: Success of India's TB control program relies on rapid case detection, monitoring, care and treatment of drug resistance. Patients on multidrug resistance (MDR) treatment are monitored by follow up cultures. Discordant results (culture and smear positive while capilia negative) are usually declared negative Mycobacterium tuberculosis complex (MTBC). This study was designed to understand the possible causes of discordant results. METHODS: The capilia kit was evaluated to test its utility among 4737 follow up MDR patients enrolled during a period of 1 year. A total of 889 were liquid culture positive, 3375 were negative and 473 were contaminated. Of the 889 cultures positive, 829 were found positive by ZN smear, capilia test and MTBDR plus assay. The cultures which gave a positive result on Mycobacterium Growth Indicator Tube 960 (MGIT 960) and ZN smear but were negative on capilia test with no growth on Brain Heart Infusion agar (BHI) were included in this study. The conflicting results of capilia were compared with other molecular techniques; MTBDR plus assay and DNA sequence analysis of MPT64 gene. RESULTS: Out of 889 culture positive, 60 (6.7%) were found positive on liquid culture and ZN smear but were negative on capilia. Of these 60 cultures, 10 (16.7%) were found positive by both MTBDR plus assay and PCR. The sequencing analysis revealed that all of the capilia negative isolates had mutations within the MPT64 gene. CONCLUSION: Re-evaluation of culture positive but capilia negative isolates should be done before declaring them as Mycobacterium other than tuberculosis (MOTT) because such cases can act as chronic carriers of TB in the population which can lead to the rise of this lethal disease.


Assuntos
Antígenos de Bactérias/genética , Imunoensaio/normas , Mycobacterium tuberculosis/isolamento & purificação , Kit de Reagentes para Diagnóstico/normas , Tuberculose/diagnóstico , Adulto , Estudos Transversais , Confiabilidade dos Dados , Resistência a Múltiplos Medicamentos/efeitos dos fármacos , Feminino , Seguimentos , Humanos , Índia , Masculino , Mutação , Reação em Cadeia da Polimerase/métodos , Sensibilidade e Especificidade , Análise de Sequência de DNA/métodos , Tuberculose/microbiologia , Adulto Jovem
11.
BMC Infect Dis ; 19(1): 1047, 2019 Dec 10.
Artigo em Inglês | MEDLINE | ID: mdl-31823734

RESUMO

BACKGROUND: Molecular tests can allow the rapid detection of tuberculosis (TB) and multidrug-resistant TB (MDR-TB). TB-SPRINT 59-Plex Beamedex® is a microbead-based assay developed for the simultaneous spoligotyping and detection of MDR-TB. The accuracy and cost evaluation of new assays and technologies are of great importance for their routine use in clinics and in research laboratories. The aim of this study was to evaluate the performance of TB-SPRINT at three laboratory research centers in Brazil and calculate its mean cost (MC) and activity-based costing (ABC). METHODS: TB-SPRINT data were compared with the phenotypic and genotypic profiles obtained using Bactec™ MGIT™ 960 system and Genotype® MTBDRplus, respectively. RESULTS: Compared with MGIT, the accuracies of TB-SPRINT for the detection of rifampicin and isoniazid resistance ranged from 81 to 92% and 91.3 to 93.9%, respectively. Compared with MTBDRplus, the accuracies of TB-SPRINT for rifampicin and isoniazid were 99 and 94.2%, respectively. Moreover, the MC and ABC of TB-SPRINT were USD 127.78 and USD 109.94, respectively. CONCLUSION: TB-SPRINT showed good results for isoniazid and rifampicin resistance detection, but still needs improvement to achieve In Vitro Diagnostics standards.


Assuntos
Farmacorresistência Bacteriana , Citometria de Fluxo/métodos , Mycobacterium tuberculosis/genética , Tuberculose/diagnóstico , Antituberculosos/farmacologia , Proteínas de Bactérias/genética , Catalase/genética , Custos e Análise de Custo , RNA Polimerases Dirigidas por DNA/genética , Farmacorresistência Bacteriana/efeitos dos fármacos , Citometria de Fluxo/economia , Genótipo , Humanos , Isoniazida/farmacologia , Testes de Sensibilidade Microbiana , Mutação , Mycobacterium tuberculosis/efeitos dos fármacos , Mycobacterium tuberculosis/isolamento & purificação , Regiões Promotoras Genéticas , Kit de Reagentes para Diagnóstico , Rifampina , Sensibilidade e Especificidade , Tuberculose/economia
12.
BMC Infect Dis ; 19(1): 1042, 2019 Dec 10.
Artigo em Inglês | MEDLINE | ID: mdl-31823777

RESUMO

BACKGROUND: Toxoplasma gondii is an opportunistic protozoan parasite that can infect all warm-blooded animals including humans and cause serious clinical manifestations. Toxoplasmosis can be diagnosed using histological, serological, and molecular methods. In this study, we aimed to detect T. gondii RE gene in various human samples by in house and commercial real time polymerase chain reactions. METHODS: A total of 38 suspected cases of toxoplasmosis [peripheral blood (n:12), amnion fluid (n:11), tissue (n:9), cerebrospinal fluid (n:5), and intraocular fluid (n:1)] were included to the study. An in house and a commercial RT-PCR were applied to investigate the T. gondii RE gene in these samples. RESULTS: The compatibility rate of the two tests was 94.7% (37/38). When the commercial RT-PCR kit was taken as reference, the sensitivity and specificity of in house RT-PCR test was 87.5 and 100%. When the in house RT-PCR test was taken as reference, the commercial RT-PCR kit has 100% sensitivity and 96.8% specificity. Incompatibility was detected in only in a buffy coat sample with high protein content. CONCLUSIONS: Both the commercial and in house RT-PCR tests can be used to investigate T. gondii RE gene in various clinical specimens with their high sensitivity and specificity. In house RT-PCR assay can be favorable due to cost savings compared to using the commercial test.


Assuntos
DNA de Protozoário/metabolismo , Reação em Cadeia da Polimerase em Tempo Real/métodos , Toxoplasma/genética , Líquido Amniótico/microbiologia , Animais , Buffy Coat/microbiologia , DNA de Protozoário/isolamento & purificação , Humanos , Masculino , Kit de Reagentes para Diagnóstico , Toxoplasma/isolamento & purificação , Toxoplasmose/diagnóstico , Toxoplasmose/microbiologia , Turquia
13.
Pol J Vet Sci ; 22(4): 789-792, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31867924

RESUMO

We measured the bone-specific alkaline phosphatase (ALP) isoenzyme activity in 67 plasma samples from 14 newborn Holstein calves using both a conventional method (featuring heat inactivation) and a commercial agarose gel electrophoresis (AGE) kit; the relevant isoenzymes were termed bone-specific ALP (BAP) and ALP isoenzyme 3 (ALP3). We explored whether the AGE kit afforded reliable data when used to analyze samples from Holstein calves. The blood was collected from the jugular vein of each calf immediately prior to the first colostrum feeding (pre-feeding), 20 and 40 h after pre-feeding, and on days 4 and 7; whereas three samples (from three calves) were not obtained. The total plasma ALP activity varied widely, exceeding the ranges of reference values. On electrophoresis, 52 of 67 plasma samples (77.6 %) clearly contained both ALP isoenzyme 2 and ALP3, as did control human serum. The total ALP activity of the 52 samples ranged from 166-1989 U/L (median: 1013 U/L), whereas the values for the other 15 samples (22.4%) exhibiting abnormal isoenzyme fractionation ranged from 1014-5118 U/L (median: 1780 U/L). In the 52 plasma samples exhibiting clearly separated isoenzymes, ALP3 and BAP activities were strongly positively correlated as revealed by Deming regression (y = 0.93x + 22.6, p⟨0.0001) and Bland-Altman analysis (ALP3/BAP activities limit of agreement: -5.1%). Thus, the AGE kit yields useful information on newborn calves, and can replace the conventional method when the total plasma ALP activity is less than approximately 1000 U/L.


Assuntos
Fosfatase Alcalina/sangue , Osso e Ossos/enzimologia , Bovinos/sangue , Eletroforese em Gel de Ágar/veterinária , Fosfatase Alcalina/metabolismo , Animais , Animais Recém-Nascidos , Isoenzimas/sangue , Kit de Reagentes para Diagnóstico
14.
Pol J Vet Sci ; 22(4): 725-733, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31867925

RESUMO

The objective of this study was to determine the applicability of the Migratest® kit for evaluating the chemotactic activity of peripheral blood neutrophils in goats. The experiment was performed on 14 goat kids aged 30±2 days, divided into two groups of 7 animals each: C - control group, and E - experimental group, supplemented with ß-hydroxy-ß-methylbutyrate (HMB), a typical immunostimulant which influences the phagocytic activity of peripheral neutrophils. The feed administered to experimental goat kids was supplemented with HMB at 40 mg/kg BW, whereas control goat kids were administered standard farm-made feed without supplementation. Blood was sampled from the jugular vein immediately before the experiment (day 0) and on experimental days 15, 30 and 60 to determine the chemotactic activity of peripheral blood neutrophils in goats. The results of the study indicate that the Migratest® kit can be used to evaluate the influence of immunomodulators on the chemotactic activity of peripheral blood neutrophils in goats. The results of the assay are most effectively presented by calculating the chemotactic index which accounts for the chemotaxis or migration of neutrophils in the presence or absence of a chemotactic factor, respectively, and the percentage of granulocytes that migrate towards fMLP. The results of both presentation methods appear to be identical.


Assuntos
Cabras/sangue , Neutrófilos/efeitos dos fármacos , Kit de Reagentes para Diagnóstico/veterinária , Valeratos/administração & dosagem , Ração Animal/análise , Animais , Dieta/veterinária , Suplementos Nutricionais , Neutrófilos/fisiologia
15.
Klin Lab Diagn ; 64(11): 700-704, 2019.
Artigo em Russo | MEDLINE | ID: mdl-31747502

RESUMO

The reagent kit AmpligenBurk-mallei/pseudomallei-RT PCR is designed for detecting in vitro diagnostics and differentiate the DNA of glanders and melioidosis pathogens by real-time multiplex PCR in biological (clinical) material and cultures of microorganisms, as well as environmental objects and solid food products (rice). During clinical testing diagnostic value of reagent kit AmpligenBurk-mallei/pseudomallei-RT PCR has been studied. Based on the results obtained, a high analytical sensitivity (1×103 microbe cells/ml) and specificity (100%) of PCR-RT with the developed reagent kit were established, regardless of the type of material being studied. The diagnostic sensitivity of PCR-RT using a set of reagents was at least 98.0% and specificity at least 99%. The stages of state examination have been completed, a registration certificate has been obtained at Roszdravnadzor, production, sale and use of reagent kit in medical laboratory practice have been permitted.


Assuntos
Mormo/diagnóstico , Melioidose/diagnóstico , Kit de Reagentes para Diagnóstico/normas , Reação em Cadeia da Polimerase em Tempo Real/veterinária , Animais , Burkholderia mallei , Burkholderia pseudomallei , Cavalos , Sensibilidade e Especificidade
16.
BMC Infect Dis ; 19(1): 942, 2019 Nov 07.
Artigo em Inglês | MEDLINE | ID: mdl-31699044

RESUMO

BACKGROUND: Initiating early effective antimicrobial therapy is the most important intervention demonstrated to decrease mortality in patients with gram-negative bacteremia with sepsis. Rapid MIC-based susceptibility results make it possible to optimize antimicrobial use through both escalation and de-escalation. METHOD: We prospectively evaluated the performance of the Accelerate Pheno™ system (AXDX) for identification and susceptibility testing of gram-negative species and compared the time to result between AXDX and routine standard of care (SOC) using 82 patient samples and 18 challenge organisms with various confirmed resistance mechanisms. The potential impact of AXDX on time to antimicrobial optimization was investigated with various simulated antimicrobial stewardship (ASTEW) intervention models. RESULTS: The overall positive and negative percent agreement of AXDX for identification were 100 and 99.9%, respectively. Compared to VITEK® 2, the overall essential agreement was 96.1% and categorical agreement was 95.4%. No very major or major errors were detected. AXDX reduced the time to identification by an average of 11.8 h and time to susceptibility by an average of 36.7 h. In 27 patients evaluated for potential clinical impact of AXDX on antimicrobial optimization, 18 (67%) patients could potentially have had therapy optimized sooner with an average of 18.1 h reduction in time to optimal therapy. CONCLUSION: Utilization of AXDX coupled with simulated ASTEW intervention notification substantially shortened the time to potential antimicrobial optimization in this cohort of patients with gram-negative bacteremia. This improvement in time occurred when ASTEW support was limited to an 8-h coverage model.


Assuntos
Gestão de Antimicrobianos/métodos , Infecções por Bactérias Gram-Negativas/diagnóstico , Adulto , Antibacterianos/farmacologia , Antibacterianos/uso terapêutico , Farmacorresistência Bacteriana/efeitos dos fármacos , Bactérias Gram-Negativas/efeitos dos fármacos , Bactérias Gram-Negativas/isolamento & purificação , Infecções por Bactérias Gram-Negativas/tratamento farmacológico , Infecções por Bactérias Gram-Negativas/microbiologia , Humanos , Testes de Sensibilidade Microbiana , Estudos Prospectivos , Kit de Reagentes para Diagnóstico
17.
Klin Lab Diagn ; 64(9): 571-577, 2019.
Artigo em Russo | MEDLINE | ID: mdl-31610111

RESUMO

This study presents the results of laboratory trials of the reagent kit for the rapid detection of RNA of the Crimean-Congo hemorrhagic fever virus (CCHFV) using loop-mediated isothermal amplification with reverse transcription (RT-LAMP). The developed RT-LAMP reagent kit was used to detect the CCHFV and showed a sensitivity of 103 GE/ml of viral RNA, which is sufficient for detection of the CCHFV in the early stage of human infections. The kit showed high specificity and no cross-reactivity with viral panel from the State collection of viruses of the FBRI SRC VB «Vector¼ (arboviruses and hemorrhagic fever viruses). Laboratory trials of the RT-LAMP kit are showed a high analytical and diagnostic sensitivity and specificity for RNA detection of the CCHFV and high speed of the analysis (60-70 min with sample preparation) compared to real-time PCR. Approbation of the kit field version has showed the possibility of setting the RT-LAMP reaction and viral RNA detection without the using of analytical equipments.


Assuntos
Vírus da Febre Hemorrágica da Crimeia-Congo/isolamento & purificação , Febre Hemorrágica da Crimeia/diagnóstico , Técnicas de Amplificação de Ácido Nucleico , Kit de Reagentes para Diagnóstico , Humanos , RNA Viral/análise , Reação em Cadeia da Polimerase em Tempo Real , Transcrição Reversa , Sensibilidade e Especificidade
18.
J Korean Med Sci ; 34(38): e246, 2019 Oct 07.
Artigo em Inglês | MEDLINE | ID: mdl-31583869

RESUMO

BACKGROUND: C-reactive protein (CRP) is an acute-phase protein whose level increases in response to tissue injury, infection, or other inflammation. It is used in clinical and forensic settings. Point-of-care (POC) testing has recently become available, and it is considered to be useful during postmortem examinations. However, laboratory testing of postmortem blood samples is difficult due to hemolysis and postmortem clotting. METHODS: The utility of POC testing for CRP during postmortem examination was evaluated using cardiac blood from the inferior vena cava. The whole blood sample was immediately tested using the POC instrument. Subsequently, the same sample was processed to obtain the serum, which was tested using common laboratory instruments. RESULTS: The postmortem POC test had a high positive predictive value and specificity, and the results strongly correlated with the laboratory test results. CONCLUSION: POC CRP testing is valid in postmortem examination and can be used in forensic medicine (postmortem inspection and autopsy).


Assuntos
Proteína C-Reativa/análise , Medicina Legal/métodos , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Pré-Escolar , Feminino , Humanos , Imunoensaio , Masculino , Pessoa de Meia-Idade , Testes Imediatos , Kit de Reagentes para Diagnóstico , Veia Cava Inferior/patologia
19.
BMC Infect Dis ; 19(1): 842, 2019 Oct 15.
Artigo em Inglês | MEDLINE | ID: mdl-31615443

RESUMO

BACKGROUND: HPV test implementation as a primary screening tool has the potential to decrease cervical cancer incidence as shown by several studies around the world. However, in many low-resource settings, the HPV test introduction has been backed down mainly due to its price. In this study, we present a novel low-cost strategy involving simple devices and techniques for high-risk human papillomavirus (HR-HPV) detection. The analytical performance to detect HR-HPV infections of this novel strategy was assessed by comparing it with the Hybrid Capture 2 system (HC2), which is used as gold standard. METHODS: Paired-cervical samples were collected from 541 women assisting to gynecological services in an outpatient clinic. One sample was transported in the Hybrid Capture Standard Transport Medium for HR-HPV detection by the HC2. The second sample was transported on glass slide for detection by PCR-based techniques (GP-EIA, BSGP-EIA and pU 1 M-L/2R). RESULTS: The level of agreement between the PCR-based techniques and HC2 system was determined with the Cohen's kappa value. The kappa values between HC2 and GP-EIA, BSGP-EIA and pU 1 M-L/2R were 0.71 (CI 95% 0.63-0.78), 0.78 (CI 95% 0.71-0.84) and 0.63 (CI 95% 0.55-0.72), respectively. However, when the results from both BSGP-EIA and pU 1 M-L/2R were combined, the level of agreement with HC2 was increased to 0.82 (CI 95% 0.76-0.88), reflecting a very good agreement between the two HR-HPV detection strategies. Furthermore, the sensitivity of both techniques combined was also increased compared to the BSGP-EIA (88.7% vs 77.4%) and the pU (88.7 vs 60.9%) without penalizing the specificity obtained with the BSGP-EIA (95.1% vs 96.9%) and the pU (95.1% vs 96.5%). CONCLUSIONS: This novel strategy, combining two PCR-based techniques for HR-HPV detection, could be useful for cervical cancer screening in self-collected samples in low-income countries.


Assuntos
DNA Viral/análise , Papillomaviridae/genética , Infecções por Papillomavirus/diagnóstico , Reação em Cadeia da Polimerase/métodos , Neoplasias do Colo do Útero/diagnóstico , Colo do Útero/patologia , DNA Viral/metabolismo , Detecção Precoce de Câncer , Feminino , Genótipo , Humanos , Papillomaviridae/isolamento & purificação , Infecções por Papillomavirus/virologia , Reação em Cadeia da Polimerase/economia , Kit de Reagentes para Diagnóstico , Risco , Sensibilidade e Especificidade , Análise de Sequência de DNA , Neoplasias do Colo do Útero/prevenção & controle , Neoplasias do Colo do Útero/virologia
20.
BMC Infect Dis ; 19(1): 852, 2019 Oct 15.
Artigo em Inglês | MEDLINE | ID: mdl-31615537

RESUMO

BACKGROUND: The dual challenge of low diagnostic sensitivity of microscopy test and technical challenge of performing a TB culture test poses a problem for case detection and initiation of Tuberculosis (TB) second-line treatment. There is thus need for a rapid, reliable and easily accessible assay. This comparative analysis was performed to assess diagnostic performance characteristics of GeneXpert MTB/RIF and Line Probe Assay (LPA). METHODS: Three hundred twenty nine sputum samples of patients across the 47 counties in Kenya suspected to have drug resistant TB were picked and subjected to GeneXpert, LPA and Culture MGIT at the National TB Reference Laboratory. Sensitivity, specificity and predictive values were then determined to assess the performance characteristics of the various assays. RESULTS: Against culture MGIT as the gold standard for TB diagnosis, GeneXpert had a sensitivity, specificity, positive predictive value, and negative predictive value of 78.5, 64.9, 59.4 and 82.2% respectively while LPA had 98.4, 66.0, 65.4 and 98.4%. For diagnosis of rifampicin mono-resistance GeneXpert had a moderate agreement (Kappa 0.59, P < 0.01) (sensitivity 62.50%, specificity 96.50%) while LPA that had almost perfect agreement (Kappa = 0.89, p < 0.01) with a (sensitivity 90.0% and specificity 99.1%). CONCLUSION: LPA has a better performance characteristic to GeneXpert and an alternative to culture with regards to detection of RIF's mono-resistance.


Assuntos
Farmacorresistência Bacteriana/genética , Mycobacterium tuberculosis/genética , Rifampina/uso terapêutico , Tuberculose/diagnóstico , Proteínas de Bactérias/genética , Feminino , Humanos , Quênia , Masculino , Reação em Cadeia da Polimerase Multiplex/métodos , Mycobacterium tuberculosis/isolamento & purificação , Hibridização de Ácido Nucleico/métodos , Oxirredutases/genética , Kit de Reagentes para Diagnóstico , Sensibilidade e Especificidade , Escarro/microbiologia , Tuberculose/tratamento farmacológico
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