Alere™ q HIV-1/2 Detect
Supporting Data
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Diagnostic Specificity1
To determine the diagnostic specificity of Alere™ q HIV-1/2 Detect, 1204 fresh and frozen whole blood and plasma samples from confirmed HIV negative European patients were tested.
The observed diagnostic specificity of Alere™ q HIV-1/2 Detect for both whole blood and plasma samples was 100%.
Whole Blood Samples:
Alere™ q HIV-1/2 Detect Confirmed HIV-negative Detected 0 Undetected 600 Total 600 Observed Diagnostic Specificity:100%
Blood Plasma Samples:
Alere™ q HIV-1/2 Detect Confirmed HIV-negative Detected 0 Undetected 604 Total 604 Observed Diagnostic Specificity:100%
Diagnostic Sensitivity1
To determine the diagnostic sensitivity of Alere™ q HIV-1/2 Detect, 508 frozen whole blood and plasma samples from treatment naive European patients with confirmed HIV infection were tested. Only patients with plasma viral loads >4000 cp/mL (Roche COBAS AmpliPrep/COBAS TaqMan HIV-1 v2.0) were included in the analysis.
The observed diagnostic sensitivity of Alere™ q HIV-1/2 Detect for both whole blood and plasma samples above a viral load cut off of 4000 cp/mL was 99.5%; 95% CI: 97.4-99.9.
Whole Blood Samples:
Alere™ q HIV-1/2 Detect Confirmed HIV-positive Detected 212 Undetected 1 Total 213 Observed Diagnostic Sensitivity:99.5%, 95% Confidence Interval: [97.4%,99.9%]
Blood Plasma Samples:
Alere™ q HIV-1/2 Detect Confirmed HIV-positive Detected 212 Undetected 1 Total 213 Observed Diagnostic Sensitivity:99.5%, 95% Confidence Interval: [97.4%,99.9%]
Ten commercially available seroconversion panels including 126 samples were also tested and compared against the results of a current 4th generation HIV diagnostic ELISA assay.
In three of the 10 panels Alere™ q HIV-1/2 Detect detected an HIV infection earlier than ELISA, shortening the window period by 3-4 days for the respective patients.
For seroconversion panels results were as the following:
Number of Panel Members Detected Days to First HIV Detected Panel ID Number of Panel Members Tested Alere™ q HIV-1/2 Abbott ARCHITECT® HIV Ag/Ab COMBO Alere™ q HIV-1/2 Abbott ARCHITECT® HIV Ag/Ab COMBO Difference in days to first HIV detected (NAT minus Ag/Ab) 12007 9 6 6 117 117 0 6247 9 3 3 21 21 0 9016 10 3 2 27 30 -3 9018 11 3 3 28 28 0 9020 22 4 3 87 90 -3 9022 7 2 2 22 22 0 9024 12 2 1 49 53 -4 9025 12 2 2 85 85 0 9067 9 3 3 66 66 0 9079 25 17 17 40 40 0 Total Median = 0
Mean = -1
Genotype Subtype1
The analytical performance of Alere™ q HIV-1/2 Detect with HIV-1 and HIV-2 subtypes was evaluated by testing isolates of HIV-1 group M subtypes A through H, group N, group O and Circulating Recombinant Forms (CRFs), and isolates of HIV-2 group A, B, A/B and an indeterminate subtype.
All isolates used in this study were members of subtype panels provided by the German National Reference Center for Retroviruses (GNRCR), Erlangen, Germany. Viruses were cultivated on cells and supernatants were diluted in HIV-negative plasma and quantified using different real time PCR assays at the GNRCR.
HIV-samples were originally obtained from virus isolates contributed by the NIH AIDS Research and Reference Reagent Program, USA or from the Program EVA Centre for AIDS Reagents, NIBSC, UK.
All subtypes were successfully detected by Alere™ q HIV-1/2 Detect at their respective concentrations. No false negative results for HIV-1 group M/N and O or HIV-2 were observed.
Results of Genotype Subtype Study:
Type Group Subtype Alere™ q HIV-1/2 Detect (N (un)detected / N valid) HIV-1 M/N HIV-1 O HIV-2 HIV-1 M A Detected (10/10) Undetected (10/10) Undetected (10/10) Detected (10/10) Undetected (10/10) Undetected (10/10) B Detected (10/10) Undetected (10/10) Undetected (10/10) Detected (10/10) Undetected (10/10) Undetected (10/10) C Detected (10/10) Undetected (10/10) Undetected (10/10) Detected (11/11) Undetected (11/11) Undetected (11/11) D Detected (10/10) Undetected (10/10) Undetected (10/10) Detected (10/10) Undetected (10/10) Undetected (10/10) Detected (10/10) Undetected (10/10) Undetected (10/10) CRF01_AE Detected (10/10) Undetected (10/10) Undetected (10/10) F Detected (10/10) Undetected (10/10) Undetected (10/10) Detected (10/10) Undetected (10/10) Undetected (10/10) G Detected (10/10) Undetected (10/10) Undetected (10/10) H Detected (10/10) Undetected (10/10) Undetected (10/10) G/H Detected (10/10) Undetected (10/10) Undetected (10/10) CRF02/AG Detected (10/10) Undetected (10/10) Undetected (10/10) O n/a Undetected (10/10) Detected (10/10) Undetected (10/10) n/a Undetected (10/10) Detected (10/10) Undetected (10/10) N n/a Detected (10/10) Undetected (10/10) Undetected (10/10) HIV-2 A n/a Undetected (10/10) Undetected (10/10) Detected (10/10) n/a Undetected (10/10) Undetected (10/10) Detected (10/10) n/a Undetected (10/10) Undetected (10/10) Detected (10/10) n/a Undetected (10/10) Undetected (10/10) Detected (10/10) n/a Undetected (10/10) Undetected (10/10) Detected (10/10) A/B n/a Undetected (10/10) Undetected (10/10) Detected (10/10) B n/a Undetected (10/10) Undetected (10/10) Detected (10/10) Indeterminate n/a Undetected (10/10) Undetected (10/10) Detected (10/10) -
Independent POC EID Field Study in a Resource Limited Setting
A total of 827 infants (aged 1 to 18 months; median = 1.4 months) born to HIV positive mothers were enrolled in a study to establish the diagnostic accuracy of Alere™ q HIV-1/2 Detect* in a resource limited setting.2 Testing was performed by trained nurses at five primary health clinics in Maputo, Mozambique. Results were compared to those from dried blood spots analyzed by Roche COBAS AmpliPrep/COBAS TaqMan (CAP/CTM 96) HIV-1 Qualitative Test as the reference.
- The sensitivity and specificity of clinic-based EID with Alere™ q HIV-1/2 Detect were 98.5% (95% CI: 91.7-99.9) and 99.9% (95% CI: 99.3-100), respectively
- High overall agreement (Cohen Kappa = 0.981; 95% CI: 0.96-1.00)
- Primary healthcare nurses accurately performed Alere™ q HIV-1/2 Detect testing within primary healthcare clinics
- Performance of Alere™ q HIV-1/2 Detect in infants is comparable to that of Roche CAP/CTM HIV-1
This study demonstrates that accurate POC EID using a nucleic acid-based test is possible in primary healthcare settings. Such technology should be considered in efforts to address critical gaps in access to pediatric ART.
Jani IV, et al. JAIDS. 2014 Jun 13*For this study a prototype version of the final product was used.
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Performance of clinic-based point of care early infant HIV diagnosis with Alere™ q HIV-1/2 Detect compared with reference laboratory EID using the Roche CAP/CTM qualitative HIV-1 assay.
Roche CAP/CTM Alere™ q Sensitivity [95% C.I.] Alere™ q Specificity [95% C.I.] Alere™ q Positive Negative 98.5%
[91.7%, 99.9%]99.9%
[99.3%, %]Positive 64 1 Negative 1 761 Adapted from Jani IV, et al. J Acquir Immune Defic Syndr. 2014 Jun 13. [Epub ahead of print]
References
- Alere internal evaluation [data on file]
- Jani IV, Meggi B, Mabunda N, et al. Accurate Early Infant HIV Diagnosis in Primary Health Clinics Using a Point-Of-Care Nucleic Acid Test. J Acquir Immune Defic Syndr. 2014 Jun 13. [Epub ahead of print]
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