Performance evaluation of a point-of-care whole blood viral load test (SAMBA II HIV-1 Semi-Q Whole Blood) to optimise HIV treatment

Comparing a new point-of-care whole blood viral load test (SAMBA II HIV-1 Whole Blood Semi-Q) to a gold standard test in HIV positive patients in the UK, Ukraine and Africa: A diagnostic accuracy study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN12803987

Enrollment

2300

Registered

2016-09-02

Start date

2016-11-01

Completion date

Unknown

Last updated

2018-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections and Infestations HIV

Interventions

HIV positive patients who attend the clinic for routine VL monitoring will be invited to provide an additional blood sample for VL testing with SAMBA II HIV-1 Whole Blood Semi-Q. Trained clinic staff

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. HIV sero-positive 2. Aged 18 years and over 3. Able to understand patient information sheet and consent form

Exclusion criteria

Exclusion criteria: 1.Below 18 years old or unable to understand forms or procedure 2. Pregnant women 3. Co-infection with active TB

Design outcomes

Primary

Measure	Time frame
Diagnostic accuracy of the SAMBA HIV-1 Whole Blood Semi-Q test determined by concordance to the Gold Standard HIV viral load test (within 0.3 log10 copies/ml).	—

Secondary

Measure	Time frame
Association between collected clinical covariates (age, country and gender) with the concordance between test is determined using the Wald test statistic of parameter associated with clinical covariate in logistic regression with concordance as outcome.	—

Countries

Cameroon, Uganda, Ukraine, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026