Rapid diagnostic tests for typhoid and paratyphoid (enteric) fever


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Index Test Name Manufacturer Methods Formats Biological specimen Threshold for positivity values Number of evaluations TUBEX® TF IDL Biotech, Bromma, Sweden Inhibition Binding Magnetic Immunoassay. Detects IgM to S. Typhi O9 antigen. Semi-quantitative colorimetric. Mix buffer/reagent into plastic well with patient specimen. 3 minutes for result. Whole blood, plasma, or serum Semi-quantitative colour change scale (0 to 10) provided by manufacturer. Positive if colour change scale ≥ 3. 14 Typhidot® Malaysian Bio-Diagnostics Research, Selangor, Malaysia Dot-enzyme immunoassay. Detects IgG and IgM to 50 kdA S. Typhi Outer Membrane Protein (OMP) antigen. Mix serum/whole blood plus reagent incubating commercially-prepared pre-dotted antigen filter paper strips. 60 minutes for result. Whole blood, plasma, or serum Qualitative: either positive or negative. A positive result is a visible reaction (IgG or IgM) of an intensity equal to or greater than that of the control reaction on the commercially prepared filter paper. 17 Typhidot-M® Malaysian Bio-Diagnostics Research, Selangor, Malaysia Dot-enzyme immunoassay. Detects IgM to 50 kdA S. Typhi OMP antigen. Mix serum/whole blood plus reagent incubating commercially-prepared pre-dotted antigen filter paper strips. 60 minutes for result. Whole blood, plasma, or serum Qualitative: either positive or negative. Positive as per Typhidot. The absence of any visible spot indicated a negative test result. 6 TyphiRapid Tr-02 (Typhidot) Reszon Diagnostics International, Malaysia

Prototype of Typhidot.

Immunochromatography
assay. Detects IgM to 50 kdA S. Typhi OMP antigen.

Mix serum/whole blood plus buffer/reagent into a well. Whole blood, plasma, or serum We were unable to get hold of the manufacturer and are awaiting a response from the study author 1 KIT ICT Test-It TyphoidTM LifeAssay Diagnostics, Cape Town, South Africa Lateral flow immunochromatographic (ICT) assay. Detects IgM to S. Typhi lipopolysaccharide (LPS) antigen. Semi-quantitative. Mix serum/whole blood plus buffer/reagent into lateral flow cassette. Two-site (test and control) immunoassay on a porous nitrocellulose membrane. 15 minutes for result. Whole blood, plasma, or serum Semi-quantitative result line intensity scale (negative to +4) provided by manufacturer. A positive result is ≥ +1 3 KIT Dipstick Assay Royal Tropical Institute (KIT), Amsterdam Detects IgM to S. Typhi LPS antigen. Simplified version of ELISA technique. Strip of nitrocellulose membrane with immobilized antigen detection band. Serum plus reagent incubated on dipstick for 3 hours at room temperature. Dipsticks rinses with water and dried. >3 hours for result. Serum Semi-quantitative result line intensity scale (negative to +4) provided by manufacturer. A positive result is ≥ +1 5

KIT Dri-Dot Assay

(latex agglutination)

Royal Tropical Institute (KIT), Amsterdam Detects IgM to S. Typhi LPS antigen. White agglutination card. Dot of dried detection reagent conjugated to blue latex reagent. Antigen-activated latex stabilized by drying a drop of latex reagent onto card suspended in serum. Card rotated by hand in near-horizontal position to further induce agglutination. 30 seconds for result. Serum Qualitative: positive or negative. Positive when agglutination was observed within 30 seconds. Negative when no agglutination was observed. 1 SD Bioline Salmonella typhi IgG/IgM Fast Standard Diagnostics Inc., Gyeonggi, Korea ICT flow method. Detects IgM and IgG antibodies to unspecified S. Typhi antigens. 4 drops of reagent mixed well with patient specimen. Nitrocellulose strip suspended into with 3 sites (IgM, IgG, and control). 30 minutes for result.

Serum,

plasma, or

whole blood

Qualitative: positive or negative. Positive if line appears in both control and 1 or both of IgM or IgG test zones. 3 Enterocheck WB® Zephyr Biologicals, Goa, India

ICT

Detects IgM antibodies to S. Typhi LPS antigen.

Two-site (IgM test, and control) immunoassay cassette on a porous nitrocellulose membrane. 15 minutes for result. Whole blood, plasma, or serum Qualitative: positive or negative. Presence of a line in both the test and control zones indicates a positive result. 2 Enteroscreen ® Zephyr Biologicals, Goa, India

ICT

Detects IgM and IgG antibodies to S. Typhi LPS antigen.

Three-site (IgG, IgM, and control) immunoassay cassette on a porous nitrocellulose membrane. 15 minutes for result. Whole blood, plasma, or serum Qualitative: positive or negative. Presence of a line in both the test (IgG, IgM, or both) and control zones indicates a positive result. 1 Multi-test Dip-S-Tick PanBio Inc., Columbia, Maryland, USA Tests for five pathogens, including S. Typhi. Dipstick format that detects anti-O, anti-H,anti-Vi, IgM, or IgG antibodies. Detailed information not available Heparinized whole blood, serum, or plasma Detailed information not available 1 Mega Salmonella Mega Diagnostics, Los Angeles, California, USA Detect IgG and IgM antibodies to unspecified Salmonella antigens. Quantitatively detected by ELISA with peroxidase-labelled reagents. Results read in a microplate ELISA reader. Whole blood, serum, or plasma Detailed information not available 1 OnSite Typhoid IgG/IgM Combo CTK Biotech Inc., San Diego, California, USA

Lateral flow immunoassay.

Detects IgG and IgM antibodies against recombinant O and H S. Typhi antigens.

Three-site (IgG, IgM, and control) immunoassay cassette on a porous nitrocellulose membrane. 15 minutes for result. Whole blood, serum, or plasma Qualitative: positive or negative. Presence of a line in both the test (IgG, IgM, or both) and control zones indicates a positive result. 2