The P24 antigen test, HIV RNA PCR test, HIV isolation/culture and fourth-generation HIV uniform Ag/Ab assay are being utilized in diagnosing acute HIV infection in different labs. Many factors limit the use of screeni...The P24 antigen test, HIV RNA PCR test, HIV isolation/culture and fourth-generation HIV uniform Ag/Ab assay are being utilized in diagnosing acute HIV infection in different labs. Many factors limit the use of screening for acute HIV in high-risk populations, in blood donors and during voluntary HIV testing, including, cost, technique, sensitivity and specificity. In this review we explore a new NAAT method which involves HIV RNA RT-PCR on pooled samples. This technique is able to screen for acute infections in a large testing volume and may be used as a screening method in high-risk populations and blood donors.展开更多
A competitive internal control(IC)adapted to RT-PCR in-house assay was developed for HCV RNA detection in human pooled plasma.Also,it was applied in a multiplex RT-PCR for the HIV-1 and HCV RNA screening in human pool...A competitive internal control(IC)adapted to RT-PCR in-house assay was developed for HCV RNA detection in human pooled plasma.Also,it was applied in a multiplex RT-PCR for the HIV-1 and HCV RNA screening in human pooled plasma and plasma-derived products.A 258-bp PCR product from the 5´non-coding region of HCV genome was obtained.A competitive IC template was constructed by inserting a 52-bp double strand sequence into the NheI site of the 258-bp amplicon.This sequence was cloned and the obtained plasmid was used to generate a synthetic RNA.The IC/RNA was incorporated in in-house HCV and/or HIV PCR technique to monitor the efficiency of extraction,reverse transcription,and PCR amplification steps.IC was also used to detect all major genotypes of HCV and HIV-1 strains with similar sensitivity.The detection limit of the assay for HCV and HIV-1 was 52.7 IU/mL and 164.2 IU/mL,respectively.These techniques have been evaluated in international programs of external quality assurance with highly satisfactory results.This IC is an essential reagent in PCR techniques to detect and identify HCV and HIV-1 in pooled plasma samples involved in the manufacture of plasma-derived products as well as in the field of clinical microbiology with limited resources.展开更多
Often in longitudinal studies, some subjects complete their follow-up visits, but others miss their visits due to various reasons. For those who miss follow-up visits, some of them might learn that the event of intere...Often in longitudinal studies, some subjects complete their follow-up visits, but others miss their visits due to various reasons. For those who miss follow-up visits, some of them might learn that the event of interest has already happened when they come back. In this case, not only are their event times interval-censored, but also their time-dependent measurements are incomplete. This problem was motivated by a national longitudinal survey of youth data. Maximum likelihood estimation (MLE) method based on expectation-maximization (EM) algorithm is used for parameter estimation. Then missing information principle is applied to estimate the variance-covariance matrix of the MLEs. Simulation studies demonstrate that the proposed method works well in terms of bias, standard error, and power for samples of moderate size. The national longitudinal survey of youth 1997 (NLSY97) data is analyzed for illustration.展开更多
Background: Childhood tuberculosis accounts for about 10% of estimated TB cases in the world. Despite advances in diagnostics, childhood TB remains a challenge. We evaluated pooling method and testing with GeneXpert M...Background: Childhood tuberculosis accounts for about 10% of estimated TB cases in the world. Despite advances in diagnostics, childhood TB remains a challenge. We evaluated pooling method and testing with GeneXpert MTB/RIF in southern Ethiopia. Methods: This is a cross-sectional study in presumptive TB children st, 2nd and pooled samples. Results: Of 340 presumptive TB cases enrolled, 96 and 244 children submitted gastric aspirate and sputum samples respectively. Of 1020 samples collected (282 gastric aspirate and 738 sputum samples), 38 (3.7%) were positive by Xpert (10 (3.5%) from gastric aspirate and 28 (3.8%) from sputum sample). Similarly, 8 (1.2%) of sputum samples were positive by ZN but none from gastric aspirate. Of 244 children who submitted sputum samples, 3 (1.2%) were bacteriologically positive compared to 12 (4.9%) by Xpert. Of 96 children who submitted gastric aspirate samples, none were positive by ZN while 5 (5.2%) were positive by Xpert. Of bacteriologically confirmed TB cases 0.9% was by ZN and 4.7% by Xpert, an increase of 3.8%. Pooled testing increased positivity by 0.3% for ZN and 1.5% by Xpert compared to the 1st sample. Conclusions: Xpert MTB/RIF testing increases yield compared to ZN testing for gastric aspirate samples. The same-day approach and pooling samples improves efficient use of cartridge, reduce the number of visits for seeking diagnosis and save resources.展开更多
Purpose: To assess the efficacy and safety of Olaparib, a PARP inhibitor on progression-free survival (PFS), objective response rate (ORR) and overall survival (OS) in patients with breast and ovarian cancer. Methods:...Purpose: To assess the efficacy and safety of Olaparib, a PARP inhibitor on progression-free survival (PFS), objective response rate (ORR) and overall survival (OS) in patients with breast and ovarian cancer. Methods: Research data from clinical trials through PubMed, Science Citation Index, Elsevier Science Direct and Cochrane Library of all published studies exploring the PFS, ORR or OS of Olaparib for maintenance monotherapy on survival in breast and ovarian cancer were analysed. Pooled estimates of the ORR, weighted medians of PFS and OS from all Olaparib were calculated. Assessment of quality and level of evidence was assigned by Cochrane guidelines and guidelines of Oxford Centre for Evidence-Based Medicine. Results: Data of 893 patients (731 olaparib;162 control) from 6 trials, 2 randomised controlled trials and 4 non-randomised trials, were included. The overall median weighted PFS and OS in patients treated with Olaparib were 5.9 and 19.1 months, respectively. The pooled ORR was 25%. Olaparib showed a greater effect on PFS in patients with both wild-type BRCA and BRCA mutant gene. The most common toxicity were nausea and vomiting. Conclusions: Olaparib as maintenance monotherapy for breast and ovarian cancer is associated with promising outcomes including increased response rate and improved PFS. Its potential in clinical application is needed for further investigation in phase III trials.展开更多
文摘The P24 antigen test, HIV RNA PCR test, HIV isolation/culture and fourth-generation HIV uniform Ag/Ab assay are being utilized in diagnosing acute HIV infection in different labs. Many factors limit the use of screening for acute HIV in high-risk populations, in blood donors and during voluntary HIV testing, including, cost, technique, sensitivity and specificity. In this review we explore a new NAAT method which involves HIV RNA RT-PCR on pooled samples. This technique is able to screen for acute infections in a large testing volume and may be used as a screening method in high-risk populations and blood donors.
基金Consejo Nacional de Investigaciones Científicas y Técnicas de Argentina(CONICET),Agencia Nacional de Promoción Ciencia y Técnica(FONCYT),Ministerio de Ciencia de la Provincia de Córdoba and Secretaría de Ciencia y Tecnología de la Universidad Nacional de Córdoba(SECyT-UNC)and by own funds of the Laboratorio de Hemoderivados de la Universidad Nacional de Córdoba.S.G-R.and L.R.are a Career Investigator and a Graduate Fellow of CONICET,respectively.
文摘A competitive internal control(IC)adapted to RT-PCR in-house assay was developed for HCV RNA detection in human pooled plasma.Also,it was applied in a multiplex RT-PCR for the HIV-1 and HCV RNA screening in human pooled plasma and plasma-derived products.A 258-bp PCR product from the 5´non-coding region of HCV genome was obtained.A competitive IC template was constructed by inserting a 52-bp double strand sequence into the NheI site of the 258-bp amplicon.This sequence was cloned and the obtained plasmid was used to generate a synthetic RNA.The IC/RNA was incorporated in in-house HCV and/or HIV PCR technique to monitor the efficiency of extraction,reverse transcription,and PCR amplification steps.IC was also used to detect all major genotypes of HCV and HIV-1 strains with similar sensitivity.The detection limit of the assay for HCV and HIV-1 was 52.7 IU/mL and 164.2 IU/mL,respectively.These techniques have been evaluated in international programs of external quality assurance with highly satisfactory results.This IC is an essential reagent in PCR techniques to detect and identify HCV and HIV-1 in pooled plasma samples involved in the manufacture of plasma-derived products as well as in the field of clinical microbiology with limited resources.
文摘Often in longitudinal studies, some subjects complete their follow-up visits, but others miss their visits due to various reasons. For those who miss follow-up visits, some of them might learn that the event of interest has already happened when they come back. In this case, not only are their event times interval-censored, but also their time-dependent measurements are incomplete. This problem was motivated by a national longitudinal survey of youth data. Maximum likelihood estimation (MLE) method based on expectation-maximization (EM) algorithm is used for parameter estimation. Then missing information principle is applied to estimate the variance-covariance matrix of the MLEs. Simulation studies demonstrate that the proposed method works well in terms of bias, standard error, and power for samples of moderate size. The national longitudinal survey of youth 1997 (NLSY97) data is analyzed for illustration.
文摘Background: Childhood tuberculosis accounts for about 10% of estimated TB cases in the world. Despite advances in diagnostics, childhood TB remains a challenge. We evaluated pooling method and testing with GeneXpert MTB/RIF in southern Ethiopia. Methods: This is a cross-sectional study in presumptive TB children st, 2nd and pooled samples. Results: Of 340 presumptive TB cases enrolled, 96 and 244 children submitted gastric aspirate and sputum samples respectively. Of 1020 samples collected (282 gastric aspirate and 738 sputum samples), 38 (3.7%) were positive by Xpert (10 (3.5%) from gastric aspirate and 28 (3.8%) from sputum sample). Similarly, 8 (1.2%) of sputum samples were positive by ZN but none from gastric aspirate. Of 244 children who submitted sputum samples, 3 (1.2%) were bacteriologically positive compared to 12 (4.9%) by Xpert. Of 96 children who submitted gastric aspirate samples, none were positive by ZN while 5 (5.2%) were positive by Xpert. Of bacteriologically confirmed TB cases 0.9% was by ZN and 4.7% by Xpert, an increase of 3.8%. Pooled testing increased positivity by 0.3% for ZN and 1.5% by Xpert compared to the 1st sample. Conclusions: Xpert MTB/RIF testing increases yield compared to ZN testing for gastric aspirate samples. The same-day approach and pooling samples improves efficient use of cartridge, reduce the number of visits for seeking diagnosis and save resources.
文摘Purpose: To assess the efficacy and safety of Olaparib, a PARP inhibitor on progression-free survival (PFS), objective response rate (ORR) and overall survival (OS) in patients with breast and ovarian cancer. Methods: Research data from clinical trials through PubMed, Science Citation Index, Elsevier Science Direct and Cochrane Library of all published studies exploring the PFS, ORR or OS of Olaparib for maintenance monotherapy on survival in breast and ovarian cancer were analysed. Pooled estimates of the ORR, weighted medians of PFS and OS from all Olaparib were calculated. Assessment of quality and level of evidence was assigned by Cochrane guidelines and guidelines of Oxford Centre for Evidence-Based Medicine. Results: Data of 893 patients (731 olaparib;162 control) from 6 trials, 2 randomised controlled trials and 4 non-randomised trials, were included. The overall median weighted PFS and OS in patients treated with Olaparib were 5.9 and 19.1 months, respectively. The pooled ORR was 25%. Olaparib showed a greater effect on PFS in patients with both wild-type BRCA and BRCA mutant gene. The most common toxicity were nausea and vomiting. Conclusions: Olaparib as maintenance monotherapy for breast and ovarian cancer is associated with promising outcomes including increased response rate and improved PFS. Its potential in clinical application is needed for further investigation in phase III trials.
