Clinical Studies Clinical trials were done to test the effectiveness and accuracy of the Home Access HIV-1

Home Collection Kit which represents key milestones. wo separate clinical studies evaluated the use of an HIV-1 estin! pro!ram in the !eneral population and in the population at risk for HIV-1 infection. "or the clinical study with concerns a#out the !eneral population$ a five center study assessed the compilation of #lood spot specimens under conditions of home use a!ainst venous samples collected #y a clinic phle#otomist. A sum of %&& su#'ects were involved ran!in! from 1( to )* years in a!e. he su#'ects included +,1 men$ +%- women$ and ( unknown. In the comparison of participant-collected #lood spots compared to phle#otomist-collected #lood spots$ the participantcollected #lood spots had a sample ade.uacy of &,/ 0%)12%&&3. he phle#otomistcollected #lood spot samples were rated at &(/ 0%()2%&&3. 4verall$ the participantcollected #lood spots compared to phle#otomist-collected #lood spots was &)/ 0%)12%()3. his shows the ade.uacy of participant-collected #lood spots usin! the Home Access HIV-1 Home Collection Kit in comparison to !ettin! the #lood samples done from a professional. 5hen evaluatin! the HIV-1 test results of participant-collected #lood spots versus professionally collected venous samples$ there was a 1--/ a!reement in the results. he HIV-1 test results showed up as either ne!ative$ positive$ or uninterrupta#le. he relationship #etween the proper disposition of participants on the #asis of the licensed screenin! 0HIV-1 6IA3 plus confirmatory 0HIV-1 I"A3 tests was also 1--/. 5ithin the %)1 participant-collected #lood spot samples which were ade.uate$ %)1 had matchin! results 0HIV ne!ative3 when compared to the professionally collected venous samples. wo participant-collected #lood spot samples were ne!ative with no sufficient venous samples. 5ithin the %&& participants$ %( 0&.*/3 had at least one intricacy with specimen collection. he most fre.uent trou#le was the re.uirement for more than two sticks to o#tain an ade.uate #lood specimen. his was reported #y +( of the participants. 7et of the %( participants who reported difficulties$ ),/ of them were still a#le to offer an ade.uate #lood spot sample for testin!. 8enerally$ participant-collected #lood spots were accessi#le to the participant in +.& days 0mean3$ with a mean of 1.% days from specimen collection to receipt of sample at the la#oratory and a mean of 1., days from receipt of sample at la#oratory to accessi#ility of results at HAHC. 6valuation of a participant9s comprehension of the HIV information made o#taina#le durin! the study was #ased on the num#er of correct answers to ei!ht true or false .uestions in.uired at some point in the telephone consultation. he mean .uantity of ri!ht answers to all ei!ht statements was ).( 0&)/3. 6i!ht out of %&& participants 0+/3 accounted for ei!ht reported adverse events 0si: di;;iness and two an:iety related3. 4nly one of the reports of di;;iness was evaluated to #e possi#ly or most likely related to the Home Access HIV-l Home Collection Kit. <one of these adverse events were considered severe. In addition$ no participant departed from the study #ecause of an adverse event. <ow let=s discuss the clinical trials done on a population at risk for HIV-1 infection in contrast to the !eneral population. A four center study assessed the collection of

#lood spot specimens under circumstances of home use a!ainst venous samples accumulated #y a clinic phle#otomist. A total of ),* su#'ects 0,1* men$ +11 women$ and & unknown3 ran!ed from a!es 1) to )1. 4f these ),* su#'ects$ 1*% 0++/3 were esta#lished to #e HIV-1 positive throu!h serum testin!. 1( of those 1*% 0+1/3 were found to #e previously undia!nosed with HIV-1 infection. %(( of the ),* su#'ects stated that they had #een formerly tested for HIV. *(- of the participant collected #lood spot samples 0*(-2),* or &-/3 and *&, of the phle#otomistcollected #lood spots 0*&,2),* or &+/3 were considered ade.uate for analysis. In comparison to the phle#otomist-collected #lood spots$ the participant-collected #lood spots had a sample ade.uacy of &(/ versus the phle#otomist-collected #lood spots 0*(-2*&,3. Comparin! the samples that were ade.uate from #oth the participant-collected #lood spots and professionally collected venous samples in the HIV-1 test results 0positive$ ne!ative$ uninterrupta#le$ and not tested3 shows a 1--/ a!reement #etween the two samples within the *)* participants who provided ade.uate samples for #oth. his shows the accuracy of participantcollected #lood spots versus the professionally done method$ which is e:ceptionally alike. 4f the ),* participants$ )1 01-/3 had at a minimum one intricacy with the specimen collection process. he most !eneral intricacy was reported #y %) participants. his common intricacy was the re.uirement for more than two sticks to o#tain a sufficient #lood specimen. However$ of the )1 participants who had any pro#lems$ ,* 0))/3 were a#le to provide a sufficient #lood spot sample for testin!. 8enerally$ participant-collected #lood spots were accessi#le to the participant in 1.1 days 0mean3$ with a mean of 1.) days from specimen collection to receipt of sample at the la#oratory and a mean of 1.) days from receipt of sample at la#oratory to accessi#ility of results at HAHC. 6valuation of a participant9s comprehension of the HIV information made o#taina#le durin! the study was #ased on the num#er of correct answers to ei!ht true or false .uestions in.uired at some point in the telephone consultation. he mean .uantity of ri!ht answers to all ei!ht statements was ).* 0&*/3. Si: out of ),* 01/3 participants accounted for si: reported adverse events 0four di;;iness$ one ecchymosis 0#ruised fin!er3$ and one syncope. All of these adverse events were 'ud!ed to #e possi#ly or most likely related to the Home Access HIV-l Home Collection Kit. <one of these adverse events were considered severe. In addition$ no participant departed from the study #ecause of an adverse event. 4verall$ the performance of the Home Access HIV-1 est was shown from the collective clinical trial results to #e accurate for ade.uate samples collected #y participants in comparison havin! the #lood sample collected #y a phle#otomis. 5hen taken into account of ade.uate #lood samples collected #y participants$ the accuracy of the Home Access HIV-1 est System is estimated to #e 1--/.