Qualitative Blood Typhoid IgG/IgM Rapid test

Short Description:

Diagnostic Kit for Typhoid IgG/IgM

Methodology: Colloidal Gold

Testing time: 15 minutes

Storage temperature: 2°C-30°C

Valid Time: 24 months

Accurancy: More than 99%

Specification: 25 test/box

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Product Detail

Product Tags

1. INTEDED USE

Diagnostic Kit for Typhoid IgG/IgM (Colloidal Gold) is a rapid, serological, lateral flow chromatographic immunoassay designed for the simultaneous detection and differentiation of anti-Salmonella typhi (S.typhi) IgG and IgM in human whole blood, serum or plasma specimens. It is intended for use by healthcare professionals as a screening test and as an aid in diagnosing of infection with S. typhi. The test provides preliminary analysis results and do not serve as a definitive l diagnosis criterion. Any use or interpretation of the test must be analyzed and confirmed with alternative testing method(s) and clinical findings based on professional judgment of healthcare providers.

2. PRODUCT SPECIFICATION

Model No.	Typhoid IgG/IgM
Methodology	Colloidal Gold
Sample Type	Blood
Time to Result	10-15mins
Storage	2~30 ℃/36~86℉
Shelf Life	24 months
Certificate	ISO13485, CE Certificate, UCKA MHRA Certificate

MAIN KIT COMPONENTS

* Test device

* Sample collection tube

* Disposable pipette

* Instructions for Use

PACKING

* 20 test /kit

* Aluminum foil bag labeling

* shrink wrap

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.

4.RESULT EVALUATION AND EXPLANATION

5.CLINICAL PERFORMANCE

1.Clinical performance

The Typhoid IgG/IgM Rapid Test has been evaluated with a reference commercial ELISA test using clinical specimens. Test results are presented in the tables below.

Clinical performance for anti-S. typhi IgM Test

Baysen Result of Typhoid IgG/IgM	S. typhi IgM ELISA Test			Sensitivity (Positive Percent Agreement): 93.93% = 31/33 (95% CI: 80.39%~98.32%) Specificity (Negative Percent Agreement): 99.52% = 209/210 (95% CI: 93.75%~99.92%) Accuracy (Overall Percent Agreement): 98.76% = (31+209)/243 (95% CI: 96.43%~99.58%)
Baysen Result of Typhoid IgG/IgM	Positive	Negative	Total
Positive	31	1	32
Negative	2	209	211
Total	33	210	243

Clinical performance for anti-S. typhi IgG Test

Baysen Result of FOB	S. typhi IgG ELISA Test			Sensitivity (Positive Percent Agreement): 88.57% = 31/35 (95% CI: 74.05%~95.46%) Specificity (Negative Percent Agreement): 99.54% = 219/220 (95% CI: 97.47%~99.92%) Accuracy (Overall Percent Agreement): 98.03% = (31+219)/255 (95% CI: 95.49%~99.16%)
Baysen Result of FOB	Positive	Negative	Total
Positive	179	0	179
Negative	1	146	147
Total	180	146	326