Typhoid IgG/IgM Rapid Test Cassette

Sample

Whole Blood/Serum/Plasma

Intended Use

The Typhoid Rapid Test Cassette is a rapid chromatographic immunoassay for the simultaneous detection and differentiation of IgG and IgM types of antibodies against Salmonella typhi (S. typhi) in human whole blood, serum or plasma. It is intended to be used as a screening test as an aid in the diagnosis of infection with S. typhi. Any reactive specimen with the Typhoid rapid test cassette needs to be confirmed with alternative testing method.

Storage

Store as packaged in the sealed pouch at room temperature or refrigerated (2-30°C). The test is stable through the expiration date printed on the sealed pouch. The test must remain in the sealed pouch until use. DO NOT FREEZE. Do not use beyond the expiration date.

Precision

Intra-Assay:
Within-run precision has been determined by using 10 replicates of three specimens: a negative, a low positive and a high positive. The negative, low positive and high positive values were correctly identified >99% of the time.
Inter-Assay:
Between-run precision has been determined by 10 independent assays on the same three specimens: a negative, a low positive and a high positive. Three different lots of the Typhoid Rapid Test cassette (Whole Blood/Serum/Plasma) have been tested over a 3-day period using negative, low positive and high positive specimens. The specimens were correctly identified >99% of the time.

Sensitivity

Sensitivity and Specificity
A clinical evaluation was conducted comparing the results obtained using the Typhoid Rapid Test Cassette to Typhoid IgG/IgM ELISA Testing. The study included 314 IgG specimens and 334 IgM specimen, and about the IgG specimen both assays identified 298 negative and 13 positive results, about the IgM specimen both assays identified 298 negative and 31 positive results.