Uncut sheet for Typhoid IgG/IgM Rapid test
1. INTEDED USE
The Typhoid IgG/IgM Rapid Test Device (Uncut Sheet format for manufacturing use) is a rapid colloidal Gold intended for the qualitative and differential detection of IgG and IgM antibodies to Salmonella typhi (S. typhi) and Salmonella paratyphi (S. paratyphi) in human serum, plasma, or whole blood specimens
This test is intended for in vitro diagnostic professional use and serves as an aid in the diagnosis of typhoid fever and paratyphoid fever in patients presenting with clinical signs and symptoms suggestive of enteric fever
The test provides presumptive screening results. Results should be interpreted as follows:
- IgM positive, IgG negative: suggests recent or current (acute) infection .
- IgG positive, IgM negative: suggests past exposure or resolved infection .
- IgM and IgG negative: indicates no current or past infection, though negative results do not rule out typhoid infection, particularly if the specimen is collected during the early stage of infection when antibody titers may be below the detection limit
Positive results are preliminary and should be confirmed by alternative diagnostic methods such as blood culture or other confirmatory testing . This test is not intended for use as the sole basis for diagnosis, and results should be interpreted in conjunction with clinical presentation and exposure history .
This product is intended for use by trained healthcare professionals or laboratory personnel. This product is for manufacturing use only and is intended for further processing into final device format.
2. PRODUCT SPECIFICATION
| Model No. | Typhoid IgG/IgM Uncut sheet |
| Methodology | Colloidal Gold |
| Sample Type | Serum,Plasma,Whole blood |
| Time to Result | 15 mins |
| Storage | 2~30 ℃/36~86℉ |
| Shelf Life | 24 months |
| Certificate | ISO13485, CE Certificate, UCKA MHRA Certificate |
|
Feature • High sensitive • result reading in 5 minutes • Easy operation • High Accuracy |
PACKING * 20 bags /CTN * Aluminum foil bag labeling * shrink wrap
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3.TEST METHOD
| 1 | Take out the test device from sealed foil pouch and place on a dry, clean and level surface. |
| 2 | Be sure to label the device with specimen’s ID number. |
| 3 | Fill the pipette dropper with the specimen. Hold the dropper vertically and transfer 1 drop of whole blood/serum/plasma specimen (approximately 10 μL) into the specimen well (S) , and make sure that there are no air bubbles. Then add 3 drops of sample diluent (approximately 80-100 μL) into the diluent well (D) immediately. See illustration below. |
| 4 | Start the timer. |
| 5 | Wait for the colored line(s) to appear. Read test results at 15 minutes. Positive results maybe visible in as short as 1 minute. Negative results must be confirmed at the end of the 20 minutes only. Do not interpret the result after 20 minutes. |
5. CERTIFICATE
* ISO System Certificate
* CE Certificate
* EU Registration
* UCKA MHRA Registration




