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Abbott Laboratories pima cd4 platform
Consort diagram of screening and enrolment for the ENCORE trial. Sixteen clusters were randomized to Visitect <t>CD4</t> testing versus standard‐of‐care CD4 testing. All clusters received the allocated intervention and were included in the analysis. The average size of each cluster was 100 participants. Potential participants were screened at the point of CD4 testing (which is performed for all who are entering or re‐entering HIV care). However, given the poor specificity of the Visitect CD4 test, 294 participants initially thought to have CD4≤200 cells/µl by the Visitect CD4 test were determined to have a confirmatory CD4 result >200 cells/µl. Thus, we present an intention‐to‐treat analysis and a per‐protocol analysis, where only participants in the Visitect CD4 assignment and confirmatory CD4 testing results ≤200 cells/µl were included.
Pima Cd4 Platform, supplied by Abbott Laboratories, used in various techniques. Bioz Stars score: 86/100, based on 1 PubMed citations. ZERO BIAS - scores, article reviews, protocol conditions and more
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1) Product Images from "A cluster randomized trial of Visitect CD4 Advanced Disease platform among outpatients with advanced HIV disease in Uganda"

Article Title: A cluster randomized trial of Visitect CD4 Advanced Disease platform among outpatients with advanced HIV disease in Uganda

Journal: Journal of the International AIDS Society

doi: 10.1002/jia2.70075

Consort diagram of screening and enrolment for the ENCORE trial. Sixteen clusters were randomized to Visitect CD4 testing versus standard‐of‐care CD4 testing. All clusters received the allocated intervention and were included in the analysis. The average size of each cluster was 100 participants. Potential participants were screened at the point of CD4 testing (which is performed for all who are entering or re‐entering HIV care). However, given the poor specificity of the Visitect CD4 test, 294 participants initially thought to have CD4≤200 cells/µl by the Visitect CD4 test were determined to have a confirmatory CD4 result >200 cells/µl. Thus, we present an intention‐to‐treat analysis and a per‐protocol analysis, where only participants in the Visitect CD4 assignment and confirmatory CD4 testing results ≤200 cells/µl were included.
Figure Legend Snippet: Consort diagram of screening and enrolment for the ENCORE trial. Sixteen clusters were randomized to Visitect CD4 testing versus standard‐of‐care CD4 testing. All clusters received the allocated intervention and were included in the analysis. The average size of each cluster was 100 participants. Potential participants were screened at the point of CD4 testing (which is performed for all who are entering or re‐entering HIV care). However, given the poor specificity of the Visitect CD4 test, 294 participants initially thought to have CD4≤200 cells/µl by the Visitect CD4 test were determined to have a confirmatory CD4 result >200 cells/µl. Thus, we present an intention‐to‐treat analysis and a per‐protocol analysis, where only participants in the Visitect CD4 assignment and confirmatory CD4 testing results ≤200 cells/µl were included.

Techniques Used:

Time to ART initiation by CD4 group among participants who were ART naive. The left panel includes all participants. The right panel includes only participants with a confirmed CD4 result ≤200 cells/µl. Overall, median time to ART initiation, estimated from the Kaplan−Meier curve, was 0 days (95% CI, 0–1) among participants assigned to Visitect CD4 testing versus 7 days (95% CI, 0–12) among participants assigned to standard CD4 testing. In the Visitect CD4 arm, 54% of participants started ART on the day of enrolment; in the standard CD4 testing arm, 46% of participants started ART on the day of enrolment. Among participants with only advanced HIV disease (CD4 ≤200 cells/µl), median time to ART initiation was 5 days (95% CI, 0–10) among participants assigned to Visitect CD4 testing versus 7 days (95% CI, 0–12) among participants assigned to standard CD4 testing. Abbreviation: ART, antiretroviral therapy.
Figure Legend Snippet: Time to ART initiation by CD4 group among participants who were ART naive. The left panel includes all participants. The right panel includes only participants with a confirmed CD4 result ≤200 cells/µl. Overall, median time to ART initiation, estimated from the Kaplan−Meier curve, was 0 days (95% CI, 0–1) among participants assigned to Visitect CD4 testing versus 7 days (95% CI, 0–12) among participants assigned to standard CD4 testing. In the Visitect CD4 arm, 54% of participants started ART on the day of enrolment; in the standard CD4 testing arm, 46% of participants started ART on the day of enrolment. Among participants with only advanced HIV disease (CD4 ≤200 cells/µl), median time to ART initiation was 5 days (95% CI, 0–10) among participants assigned to Visitect CD4 testing versus 7 days (95% CI, 0–12) among participants assigned to standard CD4 testing. Abbreviation: ART, antiretroviral therapy.

Techniques Used:



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Abbott Laboratories pima cd4 platform
Consort diagram of screening and enrolment for the ENCORE trial. Sixteen clusters were randomized to Visitect <t>CD4</t> testing versus standard‐of‐care CD4 testing. All clusters received the allocated intervention and were included in the analysis. The average size of each cluster was 100 participants. Potential participants were screened at the point of CD4 testing (which is performed for all who are entering or re‐entering HIV care). However, given the poor specificity of the Visitect CD4 test, 294 participants initially thought to have CD4≤200 cells/µl by the Visitect CD4 test were determined to have a confirmatory CD4 result >200 cells/µl. Thus, we present an intention‐to‐treat analysis and a per‐protocol analysis, where only participants in the Visitect CD4 assignment and confirmatory CD4 testing results ≤200 cells/µl were included.
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Consort diagram of screening and enrolment for the ENCORE trial. Sixteen clusters were randomized to Visitect <t>CD4</t> testing versus standard‐of‐care CD4 testing. All clusters received the allocated intervention and were included in the analysis. The average size of each cluster was 100 participants. Potential participants were screened at the point of CD4 testing (which is performed for all who are entering or re‐entering HIV care). However, given the poor specificity of the Visitect CD4 test, 294 participants initially thought to have CD4≤200 cells/µl by the Visitect CD4 test were determined to have a confirmatory CD4 result >200 cells/µl. Thus, we present an intention‐to‐treat analysis and a per‐protocol analysis, where only participants in the Visitect CD4 assignment and confirmatory CD4 testing results ≤200 cells/µl were included.
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Figure 1 legend : <t>CD4</t> counts by near point of care quantitative device performed by nurses (CD4 count on y axis) and by semiquantitative LFA by HIV diagnostic assistants (color of point). Horizontal lines indicate various CD4 cell counts. Light shaded dots show concordant results; discordant results are shown as dark shaded dots. Results for six participants with CD4 >1000 (all concordant) are not shown on graph.
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Figure 1 legend : <t>CD4</t> counts by near point of care quantitative device performed by nurses (CD4 count on y axis) and by semiquantitative LFA by HIV diagnostic assistants (color of point). Horizontal lines indicate various CD4 cell counts. Light shaded dots show concordant results; discordant results are shown as dark shaded dots. Results for six participants with CD4 >1000 (all concordant) are not shown on graph.
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Figure 1 legend : <t>CD4</t> counts by near point of care quantitative device performed by nurses (CD4 count on y axis) and by semiquantitative LFA by HIV diagnostic assistants (color of point). Horizontal lines indicate various CD4 cell counts. Light shaded dots show concordant results; discordant results are shown as dark shaded dots. Results for six participants with CD4 >1000 (all concordant) are not shown on graph.
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Figure 1 legend : <t>CD4</t> counts by near point of care quantitative device performed by nurses (CD4 count on y axis) and by semiquantitative LFA by HIV diagnostic assistants (color of point). Horizontal lines indicate various CD4 cell counts. Light shaded dots show concordant results; discordant results are shown as dark shaded dots. Results for six participants with CD4 >1000 (all concordant) are not shown on graph.
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Figure 1 legend : <t>CD4</t> counts by near point of care quantitative device performed by nurses (CD4 count on y axis) and by semiquantitative LFA by HIV diagnostic assistants (color of point). Horizontal lines indicate various CD4 cell counts. Light shaded dots show concordant results; discordant results are shown as dark shaded dots. Results for six participants with CD4 >1000 (all concordant) are not shown on graph.
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Figure 1 legend : <t>CD4</t> counts by near point of care quantitative device performed by nurses (CD4 count on y axis) and by semiquantitative LFA by HIV diagnostic assistants (color of point). Horizontal lines indicate various CD4 cell counts. Light shaded dots show concordant results; discordant results are shown as dark shaded dots. Results for six participants with CD4 >1000 (all concordant) are not shown on graph.
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Consort diagram of screening and enrolment for the ENCORE trial. Sixteen clusters were randomized to Visitect CD4 testing versus standard‐of‐care CD4 testing. All clusters received the allocated intervention and were included in the analysis. The average size of each cluster was 100 participants. Potential participants were screened at the point of CD4 testing (which is performed for all who are entering or re‐entering HIV care). However, given the poor specificity of the Visitect CD4 test, 294 participants initially thought to have CD4≤200 cells/µl by the Visitect CD4 test were determined to have a confirmatory CD4 result >200 cells/µl. Thus, we present an intention‐to‐treat analysis and a per‐protocol analysis, where only participants in the Visitect CD4 assignment and confirmatory CD4 testing results ≤200 cells/µl were included.

Journal: Journal of the International AIDS Society

Article Title: A cluster randomized trial of Visitect CD4 Advanced Disease platform among outpatients with advanced HIV disease in Uganda

doi: 10.1002/jia2.70075

Figure Lengend Snippet: Consort diagram of screening and enrolment for the ENCORE trial. Sixteen clusters were randomized to Visitect CD4 testing versus standard‐of‐care CD4 testing. All clusters received the allocated intervention and were included in the analysis. The average size of each cluster was 100 participants. Potential participants were screened at the point of CD4 testing (which is performed for all who are entering or re‐entering HIV care). However, given the poor specificity of the Visitect CD4 test, 294 participants initially thought to have CD4≤200 cells/µl by the Visitect CD4 test were determined to have a confirmatory CD4 result >200 cells/µl. Thus, we present an intention‐to‐treat analysis and a per‐protocol analysis, where only participants in the Visitect CD4 assignment and confirmatory CD4 testing results ≤200 cells/µl were included.

Article Snippet: Several devices for point‐of‐care CD4 testing are commercially available, including the BD FACSPresto system (BD Biosciences, Franklin Lakes, NJ, USA) and the PIMA CD4 platform (Abbott, Chicago, IL, USA).

Techniques:

Time to ART initiation by CD4 group among participants who were ART naive. The left panel includes all participants. The right panel includes only participants with a confirmed CD4 result ≤200 cells/µl. Overall, median time to ART initiation, estimated from the Kaplan−Meier curve, was 0 days (95% CI, 0–1) among participants assigned to Visitect CD4 testing versus 7 days (95% CI, 0–12) among participants assigned to standard CD4 testing. In the Visitect CD4 arm, 54% of participants started ART on the day of enrolment; in the standard CD4 testing arm, 46% of participants started ART on the day of enrolment. Among participants with only advanced HIV disease (CD4 ≤200 cells/µl), median time to ART initiation was 5 days (95% CI, 0–10) among participants assigned to Visitect CD4 testing versus 7 days (95% CI, 0–12) among participants assigned to standard CD4 testing. Abbreviation: ART, antiretroviral therapy.

Journal: Journal of the International AIDS Society

Article Title: A cluster randomized trial of Visitect CD4 Advanced Disease platform among outpatients with advanced HIV disease in Uganda

doi: 10.1002/jia2.70075

Figure Lengend Snippet: Time to ART initiation by CD4 group among participants who were ART naive. The left panel includes all participants. The right panel includes only participants with a confirmed CD4 result ≤200 cells/µl. Overall, median time to ART initiation, estimated from the Kaplan−Meier curve, was 0 days (95% CI, 0–1) among participants assigned to Visitect CD4 testing versus 7 days (95% CI, 0–12) among participants assigned to standard CD4 testing. In the Visitect CD4 arm, 54% of participants started ART on the day of enrolment; in the standard CD4 testing arm, 46% of participants started ART on the day of enrolment. Among participants with only advanced HIV disease (CD4 ≤200 cells/µl), median time to ART initiation was 5 days (95% CI, 0–10) among participants assigned to Visitect CD4 testing versus 7 days (95% CI, 0–12) among participants assigned to standard CD4 testing. Abbreviation: ART, antiretroviral therapy.

Article Snippet: Several devices for point‐of‐care CD4 testing are commercially available, including the BD FACSPresto system (BD Biosciences, Franklin Lakes, NJ, USA) and the PIMA CD4 platform (Abbott, Chicago, IL, USA).

Techniques:

Consort diagram of screening and enrolment for the ENCORE trial. Sixteen clusters were randomized to Visitect CD4 testing versus standard‐of‐care CD4 testing. All clusters received the allocated intervention and were included in the analysis. The average size of each cluster was 100 participants. Potential participants were screened at the point of CD4 testing (which is performed for all who are entering or re‐entering HIV care). However, given the poor specificity of the Visitect CD4 test, 294 participants initially thought to have CD4≤200 cells/µl by the Visitect CD4 test were determined to have a confirmatory CD4 result >200 cells/µl. Thus, we present an intention‐to‐treat analysis and a per‐protocol analysis, where only participants in the Visitect CD4 assignment and confirmatory CD4 testing results ≤200 cells/µl were included.

Journal: Journal of the International AIDS Society

Article Title: A cluster randomized trial of Visitect CD4 Advanced Disease platform among outpatients with advanced HIV disease in Uganda

doi: 10.1002/jia2.70075

Figure Lengend Snippet: Consort diagram of screening and enrolment for the ENCORE trial. Sixteen clusters were randomized to Visitect CD4 testing versus standard‐of‐care CD4 testing. All clusters received the allocated intervention and were included in the analysis. The average size of each cluster was 100 participants. Potential participants were screened at the point of CD4 testing (which is performed for all who are entering or re‐entering HIV care). However, given the poor specificity of the Visitect CD4 test, 294 participants initially thought to have CD4≤200 cells/µl by the Visitect CD4 test were determined to have a confirmatory CD4 result >200 cells/µl. Thus, we present an intention‐to‐treat analysis and a per‐protocol analysis, where only participants in the Visitect CD4 assignment and confirmatory CD4 testing results ≤200 cells/µl were included.

Article Snippet: The most common methods of standard CD4 testing were the PIMA CD4 Analyser (Abbott) and BD FACSPresto (BD Biosciences).

Techniques:

Time to ART initiation by CD4 group among participants who were ART naive. The left panel includes all participants. The right panel includes only participants with a confirmed CD4 result ≤200 cells/µl. Overall, median time to ART initiation, estimated from the Kaplan−Meier curve, was 0 days (95% CI, 0–1) among participants assigned to Visitect CD4 testing versus 7 days (95% CI, 0–12) among participants assigned to standard CD4 testing. In the Visitect CD4 arm, 54% of participants started ART on the day of enrolment; in the standard CD4 testing arm, 46% of participants started ART on the day of enrolment. Among participants with only advanced HIV disease (CD4 ≤200 cells/µl), median time to ART initiation was 5 days (95% CI, 0–10) among participants assigned to Visitect CD4 testing versus 7 days (95% CI, 0–12) among participants assigned to standard CD4 testing. Abbreviation: ART, antiretroviral therapy.

Journal: Journal of the International AIDS Society

Article Title: A cluster randomized trial of Visitect CD4 Advanced Disease platform among outpatients with advanced HIV disease in Uganda

doi: 10.1002/jia2.70075

Figure Lengend Snippet: Time to ART initiation by CD4 group among participants who were ART naive. The left panel includes all participants. The right panel includes only participants with a confirmed CD4 result ≤200 cells/µl. Overall, median time to ART initiation, estimated from the Kaplan−Meier curve, was 0 days (95% CI, 0–1) among participants assigned to Visitect CD4 testing versus 7 days (95% CI, 0–12) among participants assigned to standard CD4 testing. In the Visitect CD4 arm, 54% of participants started ART on the day of enrolment; in the standard CD4 testing arm, 46% of participants started ART on the day of enrolment. Among participants with only advanced HIV disease (CD4 ≤200 cells/µl), median time to ART initiation was 5 days (95% CI, 0–10) among participants assigned to Visitect CD4 testing versus 7 days (95% CI, 0–12) among participants assigned to standard CD4 testing. Abbreviation: ART, antiretroviral therapy.

Article Snippet: The most common methods of standard CD4 testing were the PIMA CD4 Analyser (Abbott) and BD FACSPresto (BD Biosciences).

Techniques:

Figure 1 legend : CD4 counts by near point of care quantitative device performed by nurses (CD4 count on y axis) and by semiquantitative LFA by HIV diagnostic assistants (color of point). Horizontal lines indicate various CD4 cell counts. Light shaded dots show concordant results; discordant results are shown as dark shaded dots. Results for six participants with CD4 >1000 (all concordant) are not shown on graph.

Journal: medRxiv

Article Title: High performance of CD4 rapid testing by lay providers in Malawi: Results from a prospective diagnostic accuracy study supporting decentralized advanced HIV disease screening

doi: 10.64898/2026.01.07.26343324

Figure Lengend Snippet: Figure 1 legend : CD4 counts by near point of care quantitative device performed by nurses (CD4 count on y axis) and by semiquantitative LFA by HIV diagnostic assistants (color of point). Horizontal lines indicate various CD4 cell counts. Light shaded dots show concordant results; discordant results are shown as dark shaded dots. Results for six participants with CD4 >1000 (all concordant) are not shown on graph.

Article Snippet: The semi-quantitative LFA used was VISITECT®CD4 test product (Accubio, UK) [11,14), the quantitative near point of care device-based test was the PIMA CD4 test machine (Abbott, USA).

Techniques: Diagnostic Assay

Journal: medRxiv

Article Title: High performance of CD4 rapid testing by lay providers in Malawi: Results from a prospective diagnostic accuracy study supporting decentralized advanced HIV disease screening

doi: 10.64898/2026.01.07.26343324

Figure Lengend Snippet:

Article Snippet: The semi-quantitative LFA used was VISITECT®CD4 test product (Accubio, UK) [11,14), the quantitative near point of care device-based test was the PIMA CD4 test machine (Abbott, USA).

Techniques: Diagnostic Assay