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Objective:Conduct comprehensive analysis of the regulatory requirement of ethical review regarding to the response of public health emergency, illustrate particular ethical review and ethical administration strategies for COVID-19 Emergency Research.Methods:Theoretical discussion, case study and interpretation of international guidelines were adopted to explore challenges and possible best practices for ethical review of such research.Results:The ethical review of COVID-19 emergency research should comply with regulatory requirement in general, combined with contextual background.Conclusions:The ethical review approval criteria of COVID-19 emergency research should take into full consideration of its urgency to make sure efficient and high quality initial review, meanwhile, more attention should be paid on continuing ethical review and ethical consultation during the whole life-circle of COVID-19 Emergency Research.
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Objective@#Conduct comprehensive analysis of the regulatory requirement of ethical review regarding to the response of public health emergency, illustrate particular ethical review and ethical administration strategies for COVID-19 Emergency Research.@*Methods@#Theoretical discussion, case study and interpretation of international guidelines were adopted to explore challenges and possible best practices for ethical review of such research.@*Results@#The ethical review of COVID-19 emergency research should comply with regulatory requirement in general, combined with contextual background.@*Conclusions@#The ethical review approval criteria of COVID-19 emergency research should take into full consideration of its urgency to make sure efficient and high quality initial review, meanwhile, more attention should be paid on continuing ethical review and ethical consultation during the whole life-circle of COVID-19 Emergency Research.
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Objective To develop a novel method for genotyping rs 738409 ( C >G ) single nucleotide polymorphism ( SNP ) , and explore the association between the rs 738409 genotypes and non-alcoholic fatty liver disease ( NAFLD ) .Methods Method establishment and analysis of genetic susceptibility.The principle of amplification refractory mutation system ( ARMS) and combined a TaqMan fluorogenic probe as signal report were used , by monitoring the difference of cycle threshold (ΔCt=C allele-special primer Ct values minus G allele-special primer Ct values ) between the two PCR reactions in a real-time PCR, the method for rs738409 genotyping was established ( ARMS-TaqMan) .618 subjects ( men:401;women: 217 ) , in an annual health check-up program from January 2011 to December 2014 in Aerospace Center Hospital , were performed for rs738409 genotyping by the ARMS-TaqMan assay.Fatty liver was diagnosed based on abdominal ultrasonography .The chi-square test and multiple logistic analyses were used to analyze the relationship of rs 738409 genotypes and NAFLD.Results The ΔCt by ARMS-TaqMan for rs738409 genotyping were -13.1 ±1.4 of CC alleles ( 243 cases ) , 0.01 ±0.45 of CG alleles ( 282 cases), and 12.7 ±1.9 of GG alleles (93 cases), respectively.The GG alleles frequency of rs738409 were significantly higher in patients with NAFLD compared with subjects without NAFLD (21.5%vs 12.3%,χ2=8.677, P =0.003).In comparison to subjects with CC alleles, the OR (95% confidence interval) adjusted for age, gender, total cholesterol, triglyceride, high density lipoprotein-cholesterol, low density lipoprotein-cholesterol, fasting blood glucose and body mass index was 1.35 (0.91-2.00) in subjects with CG alleles and was 2.21 ( 1.32 -3.71 ) in subjects with GG alleles ( P =0.013 ) .Variant rs738409 genotypes were associated with significant increased trend in alanine aminotransferase ( ALT) level from CC alleles, CG alleles to GG alleles (F=8.980, P<0.001), and in aspartate aminotansferase (AST) between GG alleles and CC alleles (F=6.491, P<0.001).Conclusions The novel ARMS-TaqMan assay had the features of accuracy , one step and high-throughput for rs738409 genotyping.The G allele of rs738409 was a risk factor of NAFLD susceptibility and associated with higher level serum ALT and AST .
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<p><b>OBJECTIVE</b>To develop a real-time PCR assay for the rapid identification of Clostridium(C.)difficile and its toxin.</p><p><b>METHODS</b>TaqMan real-time PCR was developed for the rapid identification of species specific gene(tpi) of C. difficile strains and the toxins A(TcdA), B(TcdB) and truncated toxin A(TcdAT). Sensitivity, specificity and anti-interference ability of these methods were estimated, as well. Feces sampled from fifty diarrhea patients were tested by real-time PCR and compared to the results from VIDAS assay.</p><p><b>RESULTS</b>The detection limits of tpi were 6×10⁻² CFU/µl and 6 × 10⁻¹ CFU/µl in the non-oxin producing and toxin producing strains, respectively. The coefficients of variability(CV) of intra-assay and inter-assay for the detection limits of tpi in the non-toxin producing strain were 2.1% and 2.3% . The CVs of intra-assay and inter-assay for the detection limit of tpi, tcdA, tcdB and tcdAT in the toxin producing strain were 3.0% and 3.4%, 2.9% and 3.2%, 5.3% and 5.7%, 2.7% and 2.8%, respectively. No interference was detected from other genus or species in clostridium. From 50 clinical samples, thirty-nine of them were negative and six of them were positive under the TaqMan-MGB probe technique in accordance with VIDAS. Five samples appeared positive using the TaqMan-MGB probe technique, in which 3 were dubious and 2 were negative under VIDAS.</p><p><b>CONCLUSION</b>The newly developed method was a sensitive and reliable assay for rapid identification of C. difficile and its toxin. This method could be used to screen C. difficile isolates harboring truncated toxin A to avoid misdiagnosis, clinically.</p>
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Bacterial Proteins , Bacterial Toxins , Clostridioides difficile , Enterotoxins , Real-Time Polymerase Chain Reaction , MethodsABSTRACT
Objective To develop a real-time PCR assay for the rapid identification of Clostridium(C.)difficile and its toxin. Methods TaqMan real-time PCR was developed for the rapid identification of species specific gene(tpi)of C. difficile strains and the toxins A(TcdA),B(TcdB) and truncated toxin A(TcdAT). Sensitivity,specificity and anti-interference ability of these methods were estimated,as well. Feces sampled from fifty diarrhea patients were tested by real-time PCR and compared to the results from VIDAS assay. Results The detection limits of tpi were 6×10-2 CFU/μl and 6 × 10-1 CFU/μl in the non-oxin producing and toxin producing strains,respectively. The coefficients of variability (CV) of intra-assay and inter-assay for the detection limits of tpi in the non-toxin producing strain were 2.1% and 2.3%. The CVs of intra-assay and inter-assay for the detection limit of tpi,tcdA,tcdB and tcdAT in the toxin producing strain were 3.0%and 3.4%,2.9%and 3.2%,5.3%and 5.7%,2.7%and 2.8%,respectively. No interferance was detected from other genus or species in clostridium. From 50 clinical samples,thirty-nine of them were negative and six of them were positive under the TaqMan-MGB probe technique in accordance with VIDAS. Five samples appeared positive using the TaqMan-MGB probe technique,in which 3 were dubious and 2 were negative under VIDAS. Conclusion The newly developed method was a sensitive and reliable assay for rapid identification of C. difficile and its toxin. This method could be used to screen C. difficile isolates harboring truncated toxin A to avoid misdiagnosis,clinically.
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Objective To develop a real-time PCR assay for the rapid identification of Clostridium(C.)difficile and its toxin. Methods TaqMan real-time PCR was developed for the rapid identification of species specific gene(tpi)of C. difficile strains and the toxins A(TcdA),B(TcdB) and truncated toxin A(TcdAT). Sensitivity,specificity and anti-interference ability of these methods were estimated,as well. Feces sampled from fifty diarrhea patients were tested by real-time PCR and compared to the results from VIDAS assay. Results The detection limits of tpi were 6×10-2 CFU/μl and 6 × 10-1 CFU/μl in the non-oxin producing and toxin producing strains,respectively. The coefficients of variability (CV) of intra-assay and inter-assay for the detection limits of tpi in the non-toxin producing strain were 2.1% and 2.3%. The CVs of intra-assay and inter-assay for the detection limit of tpi,tcdA,tcdB and tcdAT in the toxin producing strain were 3.0%and 3.4%,2.9%and 3.2%,5.3%and 5.7%,2.7%and 2.8%,respectively. No interferance was detected from other genus or species in clostridium. From 50 clinical samples,thirty-nine of them were negative and six of them were positive under the TaqMan-MGB probe technique in accordance with VIDAS. Five samples appeared positive using the TaqMan-MGB probe technique,in which 3 were dubious and 2 were negative under VIDAS. Conclusion The newly developed method was a sensitive and reliable assay for rapid identification of C. difficile and its toxin. This method could be used to screen C. difficile isolates harboring truncated toxin A to avoid misdiagnosis,clinically.
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Objective To probe into the best measuring method about observation of efficacy for the infected people by Hp.Methods 4 patients infected by Hp took orally priplicatial drugs,we had their feces measured with HPSA reagent in the fist,the second,the third,the fourth,the fifth,the sixth,the seventh,the thirtieth,the sixtieth,the nin-etieth day and one year,and observed the efficacy.Results The HPSA results of 4 patients were positive in the first and the second days,1 patient had a positive result in the third day,while others were neg-ative,4 patients' resuts were negative from the fourth day to the seventh day,1 patient's result was positive in the thirtieth day,others were negative.4 patients' results were negative in the sixtieth,the ninetieth day and one year.Conclusions Through theraping,4 patients had been cured.Fecal HPSA's measure with ELA method was the best method about monitoring the efficacy after treatment.
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Objective To explore Sex differences of total homocysteine(tHcy) levels,and relationship between serum creatinine and homocysteine,and renal regulation to homocysteine in patients with cerebrovascular diseases within normal serum creatinine concentrations. Methods The levels of fasting serum tHcy?Scr?triglyceride(TG)?total cholesterol(TCHO)?high density lipoprotein cholesterol(HDL-C)?high density lipoprotein cholesterol(LDL-C)were determinedin groups of cerebral infarction(CI,278 males and 160 females),cerebral hemorrhage(CH,22 males and 16 females)and transient ischemic attacks(TIAs,27 males and 20 females).The situation that patients along with hypertension and diabetes mellitus were also investigated in three groups. Results Comparison in three groups:the tHcy concentrations were significantly higher in CI than in TIAs(P 0.05). Sex comparison(327 males,196 females,from CI,CH,TIAs):the tHcy concentration were significantly higher in males than females[P