Specifications

Test Principle

The test is based on lateral flow chromatographic immunoassay technology. The conjugate pad contains recombinant S. typhi H and O antigens conjugated with colloidal gold. When the specimen is added, anti-S. typhi IgM or IgG antibodies, if present, bind to the corresponding Typhoid conjugates. The complexes migrate along the membrane and are captured in the IgM or IgG test region, producing a visible colored line. A control line indicates that the test has functioned properly.

Key Advantages

Simultaneous detection and differentiation of S. typhi IgG and IgM antibodies.

Supports whole blood, serum and plasma specimens.

Fingerstick whole blood can be used, supporting convenient sample collection.

Cassette format is simple to operate and suitable for rapid screening workflows.

Results can be read at 10 minutes.

Built-in control line helps verify valid test performance.

Suitable for professional in vitro diagnostic applications and OEM supply.

How to Use

1. Bring the test device, specimen and buffer to room temperature (15–30°C) before testing.

2. Remove the test device from the sealed pouch and place it on a clean, level surface.

3. For whole blood, serum or plasma: transfer approximately 50 μL (2 drops) of specimen into the specimen well.

4. Add 1 drop of buffer and start the timer.

5. For fingerstick whole blood, approximately 50 μL (2 drops) may be transferred using a capillary tube.

6. Read the result at 10 minutes. Do not interpret the result after 20 minutes.

Result Interpretation

IgG Positive: A control line and an IgG test line appear.

IgM Positive: A control line and an IgM test line appear.

IgG & IgM Positive: A control line and both IgG and IgM test lines appear.

Negative: Only the control line appears.

Invalid: The control line does not appear. Repeat the test with a new device.

Any shade of color in the IgG or IgM test region should be considered positive. The intensity of the test line varies with the concentration of Typhoid antibodies in the specimen.

Specimen Collection & Storage

The test can be performed using whole blood collected by venipuncture or fingerstick, as well as serum or plasma. Serum and plasma may be stored at 2–8°C for up to 3 days; for longer-term storage, specimens should be kept below −20°C. Whole blood collected by venipuncture should be stored at 2–8°C when testing within 2 days. Do not freeze whole blood. Fingerstick whole blood should be tested immediately. Avoid repeated freeze-thaw cycles.

Storage & Stability

Store unused test devices unopened at 2°C–30°C. Do not freeze or expose the kit to temperatures above 30°C. If stored at 2°C–8°C, bring the test device to room temperature before opening. The test device is stable through the expiration date printed on the sealed pouch.

Performance Characteristics

The performance figures above are taken from the TYP-W21 package insert and were obtained by comparison with commercial S. typhi IgM EIA and IgG EIA methods.

FAQ

Q: What does the TYP-W21 test detect?

A: It detects and differentiates anti-Salmonella typhi IgG and IgM antibodies.

Q: What specimens can be used?

A: Whole blood, serum and plasma can be used. Whole blood may be collected by venipuncture or fingerstick.

Q: Is TYP-W21 a whole-blood test?

A: Yes. TYP-W21 supports whole blood, including fingerstick whole blood.

Q: Is the test qualitative or quantitative?

A: It is a qualitative rapid test. The intensity of the test line does not have a linear correlation with antibody titer.

Q: How much specimen is required?

A: Approximately 50 μL, or 2 drops, of specimen is required, followed by 1 drop of buffer.

OEM & Customization

TYP-W21 can be considered for OEM and private-label projects. Customization may include branding, packaging design, labeling and other project-specific requirements, subject to technical, regulatory and minimum-order requirements.

Important Note

TYP-W21 is an antibody test for S. typhi IgG and IgM. It is not a direct antigen detection test. Reactive specimens should be interpreted together with clinical findings and, where appropriate, confirmed using alternative testing methods.