Accu-Tell® Rapid Strep. A Test is a lateral flow, one-step immunoassay for the rapid,
qualitative detection of Group A Streptococcal antigen directly from throat swabs.
Sensitivity (Detectable Limits) Study
To determine the analytical sensitivity of the Accu-Tell® 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 1.5×105 organisms per test.
To determine the specificity of the Accu-Tell® 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 1.5×105 organisms/test for all strains indicate that Accu-Tell® Strep A Test is sensitive to Group A Streptococcal bacteria.
Group A Streptococcal Strains:
ss-091 ss-410 ss-492 ss-496
ss-633 ss-634 ss-635 ss-721
ss-754 ss-799 atcc-19615
Cross-reactivity studies with organisms likely to be found in the respiratory trace were also performed using the Accu-Tell® Strep A Test. The following organisms were tested at 1×108 organisms/test.
Accu-Tell ® Strep A Test gave negative results in all cases.
A correlation study between Accu-Tell® 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 Accu-Tell® 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:
Accu-Tell® Strep A
90.5% (95% Cl, 84.2% to 96.8%)
97.5% (95% Cl, 93.7% to 99.3%)
Physician Office Laboratory Studies
An evaluation of Accu-Tell® 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.
Contact Name: Karen Liu
Company Name: Accubiotech Co, .ltd
Street Address: Building 10, No.28
Yu Hua Road, Shunyi District,
Beijing 101300, China
Member name: AccuBioTech
Member Since: 15 December 2009
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