AllTest Strep A Rapid Test

The AllTest Strep A Rapid Test is a rapid chromatographic immunoassay for qualitative detection of Streptococcus pyogenes (Group A Streptococcus) antigens in throat swab specimens from patients with signs and symptoms of pharyngitis. It aids in diagnosis of Group A Streptococcus infection, though negative results must be confirmed by bacterial culture.

The device uses a cassette-format lateral flow immunoassay with rabbit anti-Strep A antibodies, compared to the predicate's strip format with goat polyclonal anti-Strep A antibodies. It achieves 5-minute result reading time (versus 10 minutes for predicate), clinical sensitivity of 95.0% (95% CI: 89.6%–97.7%), and clinical specificity of 99.0% (95% CI: 97.5%–99.6%). Analytical sensitivity is 1.0×10⁴ CFU/swab.

Not stated in this summary.

The AllTest device is substantially equivalent to the predicate Wondfo One Step Strep A Swab Test (K133343) because both use immunochromatographic assays with rabbit anti-Strep A antibodies to detect antigen in throat swab specimens for the same indication (prescription use diagnosis of Group A Streptococcus). The device demonstrates acceptable analytical performance (precision, limit of detection, absence of cross-reactivity with 47 respiratory pathogens, no interference from common throat medications), comparable clinical performance across age groups, and non-inferior sensitivity and specificity to the predicate.