The significance of early detection and isolation of infected individuals,along with the quantitative assessment of antibodies against the virus,has gained widespread recognition during the ongoing covid-19 pandemic.T...The significance of early detection and isolation of infected individuals,along with the quantitative assessment of antibodies against the virus,has gained widespread recognition during the ongoing covid-19 pandemic.This necessitates the development of cost-effective,user-friendly,decentralized testing methods characterized by both high sensitivity and specificity.In this article,we present a comprehensive review of an innovative,low-cost rapid decentralized immunoassay technology,applicable across various diagnostic and quantitative testing scenarios.Distinguishing itself from conventional immunoassay technologies,this method is featured with mechanically enhanced specificity without compromising sensitivity.We delve into the basic principle of the technology and a comparative analysis of this technology in relation to other immunodiagnostic methods,highlighting its potential applications in a wide spectrum of diagnostic tests.展开更多
Background： CD4 count is used to determine antiretroviral therapy （ART） eligibility. In China, flow cytometers are mostly located in urban areas with limited access by patients residing in remote areas. In an attem...Background： CD4 count is used to determine antiretroviral therapy （ART） eligibility. In China, flow cytometers are mostly located in urban areas with limited access by patients residing in remote areas. In an attempt to address this issue, we conducted a study to validate the performance ofAlere PIMA point-of-care CD4 analyzer. Methods： Venous and finger-prick blood specimens were collected from HIV-positive participants from two voluntary counseling and testing sites in Yunnan Province. Both venous and finger-prick blood specimens were tested with the PIMA analyzer. Venous blood specimens tested with the Becton Dickinson FACSCalibur were used as a reference. Results： Venous specimens from 396 and finger-prick specimens from 387 persons were available for analysis. CD4 counts by PIMA correlated well with those from FACSCalibur with an R2 of 0.91 for venous blood and 0.81 for finger-prick blood. Compared to FACSCalibur, the PIMA analyzer yielded lower counts with a mean bias of- 47.0 cells/μl （limit of agreement, [LOA]： -204-110 cells/μl） for venous blood and -71.0 cells/μl （LOA： -295-153 cells/μl） for finger-prick blood. For a CD4 threshold of 350 cells/μl, the positive predictive value （PPV） of PIMA was 84.2% and 75.7% and the negative predictive value （NPV） was 97.6% and 95.8% for venous and finger-prick blood, respectively. For an ART threshold of 500 cells/μl, the corresponding PPV was 90.3% and 84.0% and NPV was 94.3% and 93.4%, respectively. Conclusions： CD4 counting using venous blood with PIMA analyzers is a feasible alternative to a large flow cytometer to determine ART eligibility.展开更多
基金funded by the Singapore Ministry of Education Academic Research Funds Tier 2(MOE-T2EP50220-0015)the Ministry of Education under the Research Centres of Excellence programme,the Ministry of Education,Decentralized GAP Funding(TAP2002020-05-18)+1 种基金NUS Efforts Against COVID-19(NUSEAC)FundingNational Research Foundation(NRF)of Singapore,through its NRF Investigator-ship Programme(NRF-NRFI2016-03).
文摘The significance of early detection and isolation of infected individuals,along with the quantitative assessment of antibodies against the virus,has gained widespread recognition during the ongoing covid-19 pandemic.This necessitates the development of cost-effective,user-friendly,decentralized testing methods characterized by both high sensitivity and specificity.In this article,we present a comprehensive review of an innovative,low-cost rapid decentralized immunoassay technology,applicable across various diagnostic and quantitative testing scenarios.Distinguishing itself from conventional immunoassay technologies,this method is featured with mechanically enhanced specificity without compromising sensitivity.We delve into the basic principle of the technology and a comparative analysis of this technology in relation to other immunodiagnostic methods,highlighting its potential applications in a wide spectrum of diagnostic tests.
文摘Background： CD4 count is used to determine antiretroviral therapy （ART） eligibility. In China, flow cytometers are mostly located in urban areas with limited access by patients residing in remote areas. In an attempt to address this issue, we conducted a study to validate the performance ofAlere PIMA point-of-care CD4 analyzer. Methods： Venous and finger-prick blood specimens were collected from HIV-positive participants from two voluntary counseling and testing sites in Yunnan Province. Both venous and finger-prick blood specimens were tested with the PIMA analyzer. Venous blood specimens tested with the Becton Dickinson FACSCalibur were used as a reference. Results： Venous specimens from 396 and finger-prick specimens from 387 persons were available for analysis. CD4 counts by PIMA correlated well with those from FACSCalibur with an R2 of 0.91 for venous blood and 0.81 for finger-prick blood. Compared to FACSCalibur, the PIMA analyzer yielded lower counts with a mean bias of- 47.0 cells/μl （limit of agreement, [LOA]： -204-110 cells/μl） for venous blood and -71.0 cells/μl （LOA： -295-153 cells/μl） for finger-prick blood. For a CD4 threshold of 350 cells/μl, the positive predictive value （PPV） of PIMA was 84.2% and 75.7% and the negative predictive value （NPV） was 97.6% and 95.8% for venous and finger-prick blood, respectively. For an ART threshold of 500 cells/μl, the corresponding PPV was 90.3% and 84.0% and NPV was 94.3% and 93.4%, respectively. Conclusions： CD4 counting using venous blood with PIMA analyzers is a feasible alternative to a large flow cytometer to determine ART eligibility.
