Accurex Typhoid IgG/IgM Chromatographic Immunoassay

Accurex Typhoid IgG/IgM Chromatographic Immunoassay is a lateral flow immunochromatographic assay. The test cassette consists of: a pink-purple colored conjugate pad containing recombinant S. typhi H antigen and O antigen conjugated with colloid gold (Typhoid conjugates) and rabbit IgG-gold conjugates, a nitrocellulose membrane strip containing two test region (Test line M and G) and a control region (control line). The test line ‘M’ is pre-coated with monoclonal anti-human IgM for the detection of IgM anti-S. typhi, test line. ‘G’ is pre-coated with monoclonal anti-human IgG for the detection of IgG anti-S. typhi , 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. Anti-S. typhi IgM if present in the patient specimen will bind to the Typhoid conjugates. The immunocomplex is then captured on the membrane by the pre-coated anti-human IgM antibody at test region. M’, forming a pink-purple line at ‘M’ region, indicating a S. typhi IgM positive test result. Anti-S. typhi IgG if present in the patient specimen will bind to the Typhoid conjugates. The immunocomplex is then captured by the pre-coated reagents on the membrane, forming a pink-purple line at test region ‘G’, indicating a S. typhi IgG positive test result. Absence of any pink-purple line at test region (M and G) suggests a negative result. The test contains an internal control (control line) which should exhibit a pink-purple line of the immunocomplex of goat anti rabbit IgG/rabbit IgG-gold conjugate regardless of the color development on any of the test region. Otherwise, the test result is invalid and the specimen must be retested with another device.

Uses:
It is intended to be used as a screening test and as an aid in the diagnosis of infection with S. typhi. Any reactive specimen with the Typhoid IgG/IgM Rapid Test must be confirmed with an alternative testing method(s).

Product Specifications and Features:

• The typhoid IgG/IgM Rapid Test is a lateral flow immunoassay for the simultaneous detection and differentiation of anti-Salmonella typhi (S. typhi) IgG and IgM in human whole blood/serum/plasma

• It is intended to be used as a screening test and as an aid in the diagnosis of infection with S. typhi.

Directions For Use:
Plasma

• Collect blood specimens into a lavender, blue or green top collection tube (containing EDTA, citrate or heparin, respectively in Vacutainer® ) by veinpuncture

• Separate the plasma by centrifugation

• Carefully withdraw the plasma into new pre-labelled tube

Serum

• Collect blood specimen into a red top collection tube (containing no anticoagulants in Vacutainer®) by veinpuncture

• Allow the blood to clot

• Separate the serum by centrifugation

• Carefully withdraw the serum into a new pre-labelled tube

• Test the specimens as soon as possible after collecting

• Store specimens at 2-8°C if not tested immediately

• It can be stored for up to 5 days

• The specimens should be frozen at -20°C for longer storage

Safety Information:

• This package insert must be read completely before performing the test. Failure to follow the insert gives inaccurate test results

• Do not open the sealed pouch, unless ready to conduct the assay

• Do not use expired devices

• Bring all reagents to room temperature (15°C-30°C) before use

• Do not use the components in any other type of test kit as a substitute for the components in this kit

• Do not use hemolized blood specimen for testing. Wear protective clothing and disposable gloves while handling the kit reagents and clinical specimens. Wash hands thoroughly after performing the test

• Users of this test should follow the US CDC Universal Precautions for prevention of transmission of HIV, HBV and other blood-borne pathogens

• Do not smoke, drink, or eat in areas where specimens or kit reagents are being handled

• Dispose of all specimens and materials used to perform the test as biohazardous waste

• Handle the Negative and Positive Control in the same manner as patient specimens

• The testing results should be read within 15 minutes after a specimen is applied to the sample well or sample pad of the device. Read result after 15 minutes may give erroneous results

• Do not perform the test in a room with strong air flow, ie. an electric fan or strong air-conditioning