Fig.1 Testprincipleof DUOI µ
Table1 HIV antigenantibodydetectionassay Assaykit DUO GenscreenPlus HIV AgAb Enzygnost HIV Integral Method ELFA ELFA ELISA ELISA Solidphase Antibody detection HIV1gp16(protein) HIV1groupO gp41 (synthetic) HIV2gp6(synthetic), biotinylated HIV1gp41, HIV1groupO gp41 HIV2gp6 (syntheticpeptide) HIV1gp16 (recombinant) HIV1groupO gp41 (synthetic) HIV2gp6(synthetic) HIV1gp41(recombinant andsynthetic) HIV1groupO gp41 (recombinant) HIV2gp6(recombinant) Antigen detection Antip24mouse monoclonal Antip24mouse monoclonal Antip24mouse monoclonal Antip24rabbit polyclonal Conjugate Antibody detection HIV1gp16(protein) HIV1groupO gp41 (synthetic) HIV2gp6(synthetic), biotinylated AntihumanIgGmouse monoclonallabeledwith ALP HIV1gp41, HIV1groupO gp41, HIV2gp6(synthetic) labeledwithpod HIV1gp41(recombinant andsynthetic) HIV1groupO gp41 (synthetic) HIV2gp6(synthetic), biotinylated Antigen detection Antip24rabbitpolyclonal (biotinylated) Antip24rabbitpolyclonal (biotinylated) Antip24sheeppolyclonal (biotinylated) Antip24mouse monoclonal(biotinylated) Samplevolume(μL) 2 2 5 1 Time(min) 8 1 18 18 Support VIDASautomated analyzer VIDASautomated analyzer Microplate Microplate µ µ µ
Table2 ResultsofHIVpositiveand negative specimensby 11HIVpositive plasmaspecimens 1,228HIVnegative plasmaspecimens Sensitivity 1% (11/11) Specificity 99.8% (1,225/1,228) Resultsof Positive 11 Negative 1,225 Table Resultsof falsepositivespecimensbyotherassays Antigenantibodydetectionassay Antibodyassay NAT sampleno. DUO Genscreen PlusHIV AgAb EnzygnostHIV Integral PA (GENEDIA HIV 1/2Mix) WB (LABBLOT 1,2) AMPLICOR HIV1Monitor Ver.1.5 TV a c copies/ml X26.41 6 <4 X1516.6 <4 B6.4..2 2 <4 a TV:testvalue<.25:Negative,.25:Positive b TV:testvalue<.25:Negative,.25 TV<.5:Borderline,.5:Positive c.:cutofindex
Table4 Resultsof DUO falsepositivespecimensby NAT (AMPLICOR HIV1Monitor Ver.1.5) WB (LABBLOT 1,2) PA (GENEDIA HIV 1/2Mix) DUO Sample No. TV a.6 GM66 HIV1p68 2.48 GM6 6.1 GM68.16 4.84 GM1.45 GM15..4 GM69. GM81.4.5 GM82..9 GM1 1.25 GM125 2.89 GM15.2 GM11.6 GM1 a TV:testvalue<.25:Negative,.25 TV<.5:Borderline,.5:Positive b TV:testvalue<.25:Negative,.25:Positive Table5 ResultsofHIV antigenantibodydetectionassay,antibodyassay,antigenassay,andnucleic acidtest(nat)onworldwidehiv PerformancePanel(WWRB2) NAT Antibodyassay Antigenantibodydetectionassay WWRB2 RocheRNA RTPCR a EIA (AbbotHIV 1/2) a Enzygnost HIV Integral GenscreenPlus HIV AgAb c Genotype No. 1.2 O 1 18.1 A 2.1 G 19.51 G 4.9 A 5 15.2 G 6 22.91 HIV2 22.65 G 8.11 A 9. negative 1 2.2 HIV2 11.55 C 12. A 1 11.9 D 1.9 D 15 19.51 D 16 18.82 D 1 2.1 C 18 12.8 C 19 18.8 C 2 1.88 B 2.5 E 22 16.4 E 2 15. E 24 22. HIV2 25. B 26 18.6 B/D 2.22 F 28 2.8 B 29.1 negative a Datafrom paneldatasheet b TV:testvalue<.25:Negative,.25:Positive c.:cutofindex
Table6 Comparison ofdetection limitsby antigenantibody detection assaysusing WorldwideHIV PerformancePanel (WWRB2) Genotype PanelNo. Antigenantibody detectionassay 1:1 1:1 2 1:1 1:1 4 1:1 5 1:1 6 A WWRB22 (TV a ) VIDUSHIV DUO ( ) Genscreen( c ) Enzygnost() (19.46) d (>1.86) (16.6) (1.51) (>1.86) (> 6.1) (1.41) (1.9) (>1.86) (> 6.1) (2.42) (.) (5.1) (.6) (.2) (.) (.) (.4) (.) B WWRB226 (TV) Genscreen() Enzygnost() (22.5) (>1.86) (2.8) (11.) (>1.86) (> 6.1) (15.1) (.12) (>1.86) (> 6.1) (.5) (.16) (>16.99) (.5) (.4) (.) (.16) () (.) (.61) C WWRB2 (TV) Genscreen() Enzygnost() (2.46) (>1.86) (.19) (1.91) (>1.86) (> 6.1) (16.8) (2.59) (>1.86) (> 6.1) (4.19) () (>16.56) (.15) (.55) (2.44) (.4) (.15) (.54) D WWRB2 (TV) Genscreen() Enzygnost() (12.4) (>1.86) (.64) (2.82) (>1.86) () (1.42) (.19) (2.) (1.5) (.2) () (.54) (.4) () (.2) (.) () E WWRB22 (TV) Genscreen() Enzygnost() (1.58) (>1.86) (11.4) (9.9) (>1.86) () (.4) (1.2) (>1.86) () (.9) () (6.) (.) (.1) (.81) (.4) () F WWRB228 (TV) Genscreen() Enzygnost() (22.8) (>1.86) (.2) (1.4) (>1.86) () (.) (2.1) (>1.86) () (2.6) (.) (1.) (.24) (.6) (1.4) () (.1) (.42) G WWRB24 (TV) Genscreen() Enzygnost() (2.44) (>1.86) (2.54) (1.98) (>1.86) (> 6.1) (18.85) (4.94) (>1.86) (> 6.1) (9.2) (.5) (>15.2) (1.2) (1.4) () (2.) (.) (.2) (.48) O WWRB (TV) Genscreen() Enzygnost() (2.1) (2.48) (>1.86) (> 6.1) (.8) (.2) (>1.86) (> 6.1) (.1) (1.4) (1.2) () (.4) (.) () (.2) (.4) () HIV2 WWRB1 (TV) Genscreen() Enzygnost() (24.92) (>1.86) (2.88) (9.49) (>1.86) (> 6.1) (1.4) (1.84) (11.9) () (.65) () (.45) (2.9) (.16) (.6) (.2) () a TV:testvalue<.25:Negative,.25:Positive b TV:testvalue<.25:Negative,.25 TV<.5:Borderline,.5:Positive c.:cutofindex d :nottested
Table ResultsofantigenantibodydetectionassaysandantibodyassayonHIV p24antigenmixedtiterperformancepanel(pra) PRA Antigenantibodydetectionassay Antigenassay Antibodyassay No. group VIDAS HIV DUO Genscreen PlusHIV AgAb Enzygnost HIV Integral EIA (AbbotHIV p24antigen) d PA (GENEDIA HIV 1/2Mix) 1 2 4 5 6 8 9 1 11 12 1 15 16 1 18 19 2 a b negative c negative a Earlyseroconversionsample b Hightiterantibodysample c Negativecontrolsample d Datafrom paneldatasheet Table8 ComparisonofHIV p24antigendetectionlimitusingtwofolddilutedspecimensofculturedisolatehiv1ib Assay Twofolddilutedspecimen Antigen assay P24I p24ag pg/ml a 8.9 1.4 5.2 5. 6.9 26.5 18.6 1.4 1.4. 5.1. Antigenantibody detection assay DUO GenscreenPlusHIV AgAb EnzygnostHIV Integral TV c d 4.8 1.81 2.11 1.18.69 1.8 1.2.8 2.5 1. 1.19.6 2.4.2.88.4 1.56.5.68.6 1.1.4.54.25..29.8..59.22..1.4.18.28..8...28.2.22.26.2.1 a p24agpg/ml:<.:negative,.and<5.:equivocal, 5.:Positive b TV:testvalue<.25:Negative,.25:Positive c TV:testvalue<.25:Negative,.25 TV<.5:Borderline,.5:Positive d.:cutofindex
Table9 Comparisonofantigendetectionlimitsbyantigenantibodydetectionassaysusingantigenpositivespecimensin thepanel PanelNo. Agvolume Antigenantibody detectionassay 1:1 1:2 1:4 1:8 1:16 1:2 1:64 1:128 p24antigen detectionlimits PRB964 (AK) 256.2pg/mL DUO TV a GenscreenPlus c HIV AgAb EnzygnostHIV Integral 9.84 2. 5.6 4.52 5.55 1.9.56 2.2.1.62 2.6.9 1.5. 1.2.64.89.2..8.4.55..2 d. 4.pg/mL 2.pg/mL 2.pg/mL 128.1pg/mL PRA5 11.pg/mL DUO GenscreenHIV AgAb EnzygnostHIV Integral TV TV.2.89 2.51 1.58 1.69.5 1.54.6.98.2.99.4.56..64.19.1.5.2.15.1.1pg/mL 56.5pg/mL 56.5pg/mL 11.pg/mL PRA1 9.pg/mL DUO GenscreenHIV AgAb EnzygnostHIV Integral TV TV 2.98.82 2.52 1. 1.58. 1.5.8.84.19.89.6.45.66.19.28.5.22.1 5.pg/mL 9.pg/mL 9.pg/mL 9.pg/mL a TV:testvalue<.25:Negative,.25:Positive b TV:testvalue<.25:Negative,.25 TV<.5:Borderline,.5:Positive c.:cutofindex d :nottested
Table1 ComparisonoftheperformanceofHIV antigenantibodydetectionassay,antigenassay,nucleicacidtest(nat)andantibodyassayon1hiv1seroconversionpanels Antibodyassay NAT Antigenassay Antigenantibodydetectionassay Days since 1st bleed PanelNo. EIA (Abbot HIV 1/2) a PA (GENEDIA HIV 1/2Mix) RocheRNA RTPCR a Abbot HIVAg a P24I Enzygnost HIV Integral Genscreen PlusHIVAgAb VIDAS HIV DUO VIDAS HIV pg/ml e d TV c.52 f PRB961.44 5 (AK)2.45..15 256.2 4.52 5.6 2. 9.84 12 4 >4.86 5.96 16.64 5 >4 >2.2 11.11 22.26 19 6 >4 >2.2 8.2 1..2 PRB91.4 (AL)2.8 9 9..26 1.1.8 1.5 4 41..4 1.59.5 2.12 16 5 15. 2.51 9.5 1.82 8.95 6 1..65 1.2.28 1.8 PRB981 11. 2.49.8.85 5.2 (AM)2 >4. >6.5 >2.2 5.91 19.16 9.6 9 PRB99(E)4.6.1 (AN)5 9..19.55.45 16 6 >4. >6.5 1.91.5 1.4 >4. >6.5 18. 6.15 18. 2 8 >6.5 >2.2 16.28 15.68 9 1.5..18 PRB9452.46.24 (AU) 52.5 1.4.66.9 2.5 1 4 94.5 >. 1.26 4.98 15 5 6.9 >. 9.16.49 2 6.5.2 2 PRB9512 1.9.19.59.26.65 8 (BA) 186. 1.8 2.91 2. 6.4 11 4 >4. >. 8.8 1.98 15 5 >4. >. 6..41 19 6.44.4 PRB95.59.15 (BB)2 9.9.49 1.59.58 1.66 1 1..46 5.22.1.69 4.5 >... 1 5 >. 4.25.86 6.4.4 PRB951..1.42.2 (BC)2 44.8.81 1..52 1.5 92. >1. 1.6 4.2 1 4..42.18 PRB954.26. 1 (BD)4.2.2 5 5.1.2.8.5 1. 1 6 >4..45 >1. 5.6 12.48.1 PRB9551.2.49.19.42 (BE)2 81..5 2.11 1.1 2.6 119.9 2.11 6.8 1.1 4.1 12 4 119.5 >1. 4.81 5.49 5 adatafrom paneldatasheet btv:testvalue<.25:negative,.25:positive ctv:testvalue<.25:negative,.25 TV<.5:Borderline,.5:Positive d.:cutofindex ep24agpg/ml:<.:negative,.and<5.:equivocal, 5.:Positive f:nottested
et al. et al.
et al.