INTENDED USERapid Strep. A Test is a lateral flow, one-step immunoassay for the rapid, qualitative detection of Group A Streptococcal antigen directly from throat swabs. PERFORMANCE CHARATERISTICSSensitivity (Detectable Limits) StudyTo determine the analytical sensitivity of the Strep A Test, Group A Streptococcus bacteria organisms were grown by standard culture techniques. The detection limit of the Strep A Test was determined to be 1.5times; 105 organisms per test. Specificity StudyTo determine the specificity of the Strep A Test to Group A Streptococcal bacteria, the following Group A Streptococcal Strains at different levels of organisms pet test were examined. Positive results obtained at level of 1.5times; 105 organisms/test for all strains indicate that Strep A Test is sensitive to Group A Streptococcal bacteria. Group A Streptococcal Strains: SS-091 SS-410 SS-492 SS-496SS-633 SS-634 SS-635 SS-721SS-754 SS-799 ATCC-19615Cross-reactivity studies with organisms likely to be found in the respiratory trace were also performed using the Strep A Test. The following organisms were tested at 1times; 108 organisms/test. Group B StreptococcusGroup D StreptococcusGroup G StreptococcusStreptococcus bovisProteus vulgarisStaphylococcus epidermidisStreptococcus faeciumCorynebacterium diphtheriaeNeisseria gororrhoeaeStreptococcus mutansBordetella pertussisNeisseria meningitidisStreptococcus salivariusCandida albicansNeisseria subflava Group C StreptococcusGroup F StreptococcusPseudomonas aeruginosaStaphylococcus aureusStreptococcus faecalisEscherichia coliStaphylococcus saprophyticusStreptococcus mitisHaemophilus parahaemolyticusNeisseria lactimaStreptococcus pneumoniaeMoraxella catarrhalisNeisseria siccaStreptococcus sanguisStrep A Test gave negative results in all cases. Correlation StudyA correlation study between Strep A Test and the conventional culture tests has been determined in multi-center clinical evaluations. Throat swab specimens were taken from children and adults exhibiting symptoms of pharyngitis. The swabs were then used to inoculate blood agar plates prior to testing with the Strep A Test. Beta-hemolytic colonies from the blood agar plates were confirmed as Group A Streptococcus using serologic streptococcal grouping methods. Strep A was reported as present or not present. Semiquantitation was not performed during testing of clinical samples. The results are summarized as follows: Strep A + -- Total + 76 8 84Culture -- 4 156 160Total 80 164 244Sensitivity90.5% (95% Cl, 84.2% to 96.8%)Specificity97.5% (95% Cl, 93.7% to 99.3%)Physician Office Laboratory StudiesAn evaluation of Strep A Test was conducted at three Physician Office Laboratory sites, using a panel of coded samples containing Negative Control, Low Positive and Medium Positive specimens. Each specimen level was tested in replicates of five, at each site, over a period of five days, One hundred percent(100%) agreement with the expected results was obtained. Productivity: 2000000 Origin: China Packing: 100 Strips/Pack, 50 Cassettes/Pack Company: AccuBioTech Co., Ltd.
