Aspen Typhi Chek IgG/IgM(Serum / Plasma) Rapid 30 Test

 INTENDED USE

The Typhoid IgG/IgM Rapid Test is a lateral flow immunoassay for the qualitative detection and differentiation of IgG and IgM anti-Salmonella typhi (S. typhi) and paratyphi in human serum or plasma. It is intended to be used as a screening test and as an aid in the diagnosis of infection with S. typhi and paratyphi. Any reactive specimen with the Typhoid IgG/IgM Rapid Test must be confirmed with alternative testing method(s).

TEST PRINCIPLE

The Typhoid IgG/IgM^2.0 Rapid Test is a lateral flow chromatographic immunoassay. The test cassette consists of: 1) a burgundy colored conjugate pad containing recombinant H antigen and O antigen conjugated with colloid gold (HO conjugates) and rabbit IgG-gold conjugates, 2) a nitrocellulose membrane strip containing two test bands (G and M bands) and a control band (C band). The M band is pre-coated with monoclonal anti-human IgM for the detection of IgM anti-S. typhi and paratyphi, G band is pre-coated with reagents for the detection of IgG anti-S. typhi and paratyphi , and the C band is pre-coated with goat anti rabbit IgG.

When an adequate volume of test specimen is dispensed into the sample well of the cassette, the test specimen migrates by capillary action across the test cassette. IgM antibodies if present in the patient specimen will bind to the HO conjugates. The immunocomplex is then captured on the membrane by the pre-coated anti-human IgM antibody, forming a burgundy colored M band, indicating a S. typhi or paratyphi IgM positive test result.

IgG antibodies if present in the patient specimen will bind to the HO conjugates. The immunocomplex is then captured by the pre-coated reagents on the membrane, forming a burgundy colored G band, indicating a S. typhi or paratyphi IgG positive test result.

Absence of any test bands (M and G) suggests a negative result. The test contains an internal control (C band) which should exhibit a burgundy colored band of the immunocomplex goat anti rabbit IgG/rabbit IgG-gold conjugate regardless of the color development on any of the test bands. Otherwise, the test result is invalid and the specimen must be retested with another device.

• Store unused test devices unopened at 2°C-30°C. If stored at 2°C-8°C, ensure that the test device is brought to room temperature before opening. The test device is stable through the expiration date printed on the sealed pouch. Do not freeze the kit or expose the kit over 30°C
• Test specimens as soon as possible after collecting. Store specimens at 2°C-8°C if not tested immediately.
• Store specimens at 2°C-8°C for up to 5 days. The specimens should be frozen at -20°C for longer storage.
• Avoid multiple freeze-thaw cycles. Prior to testing, bring frozen specimens to room temperature slowly and mix gently. Specimens containing visible particulate matter should be clarified by centrifugation before testing. Do not use samples demonstrating gross lipemia, gross hemolysis or turbidity in order to avoid interference on result interpretation.

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