Product Manual

As part of the oral fluid clinical studies, information was collected from the participants regarding concurrent diseases or medical

onditions, oral pathologies, non-HIV viral infections, and other factors (e.g., use of tobacco products, mouthwash within 24 hours

of testing, concomitant medications, dental fixtures, and food or drink immediately prior to testing). None of these disease states,

edical conditions or other factors interfered with test specificity. In a separate study of 40 individuals, consumption of alcohol,

brushing of teeth, use of mouthwash or smoking tobacco 5 minutes prior to testing, were shown to have no effect on test specificity.

onetheless, it is recommended that subject observes a wait period prior to oral fluid collection, according to the Oral Fluid Collection

Procedure of this package insert.

REPRODUCIBILITY

The reproducibility of the OraQuick ADVANCE

Rapid HIV-1/2 Antibody Test was tested at 3 sites using 3 lots of the device on 3

ifferent days with 9 operators (3 per site). A blind-coded panel was tested that consisted of 5 contrived blood specimens (4 antibody-

positive and 1 antibody-negative). Test results were recorded at 20-25 minutes and at 55-60 minutes. A total of 405 tests were

performed (135/site), with a total of 81 tests per panel member. The overall reproducibility of the OraQuick ADVANCE

Rapid

IV-1/2 Antibody Test was 405/405 = 100%. Concordance between the specified assay read time limits was 99.8% (404/405); a

single HIV-1 low positive panel member that was non-reactive at the 20-25 minute read time was reactive at the 55-60 minute read

ime.

RESULTS OF UNTRAINED USER STUDY

An “Untrained User” study was conducted in which participants were given only the test instructions and asked to perform testing of

a blinded panel comprised of 6 randomized specimens of three different levels (Negative, Low Positive and High Positive OraQuick

ADVANCE

test reactivity) consisting of human plasma. The participants were not given any training on the use of the test or the

interpretation of the test results, nor were they allowed to observe the performance of the Kit Controls by the Study Coordinator. The

study protocol stipulated that professionally trained medical laboratory personnel or persons with prior experience using the OraQuick

ADVANCE

device were excluded from participation. A total of 100 participants were enrolled from a total of four sites, representing

a diverse demographic (educational, ethnic, age, gender, etc.) population.

The rate of correct results for the overall study was 98.6% (592/600). Refer to the table below for a summary of the performance

relative to the specimen type. The eight incorrect results were attributed to six participants. Of these six participants, four obtained 5

out of 6 correct results, and two participants obtained 4 out of 6 correct results.

Untrained Users Rate of Correct Test Results

Negative Low Positive High Positive Total

98.5% (197/200) 98.0% (196/200) 99.5% (199/200) 98.6% (592/600)

95% C.I. (95.7% - 99.7%) 95% C.I. (95.0% - 99.5%) 95% C.I. (97.3% - 99.9%) 95% C.I. (97.4% - 99.4%)

There were 1.7% (10/600) Invalid results reported, with 5 of the 10 Invalid results attributed to one participant. All tests were

successfully repeated, with 8/10 of the repeat test results interpreted correctly. The 2 incorrect repeat results were attributed to one

participant. While most participants were able to obtain valid results with the first attempt, one of the 100 participants experienced

five Invalid test results out of six tests performed. Operator error was observed in some cases to be attributed to specimen vial mix-

ups. These findings support the need for training of non-laboratory personnel in the handling of multiple samples in a laboratory

setting where specimens are tested in batch mode. As part of the Untrained User study, a Participant Feedback Questionnaire was

completed. All participants rated the test as ‘easy to use’ and felt ‘able to perform the test correctly.

3001-1215 0316B OQA PI US_ENG_Layout 4/14/16 2:11 PM Page 21