INTENDED USE

The One Step TOXO IgG/IgM Test is a panel of rapid qualitative lateral flow test designed for the quantitive detection of IgG/IgM antibodies to Toxoplasma gondii (TOXO) in human serum/plasma samples.

INTRODUCTION

T. gondii is an obligate intracellular protozoan parasite with a worldwide distribution (5, 6). Serological data indicate that approximately 30% of the population of most industrialized nations is chronically infected with the organism (7). When a seronegative woman becomes infected with T. gondii during pregnancy, the organism is often transmitted across the placenta to the fetus (5, 8). The severity of the infection in the fetus varies with the trimester during which the infection was acquired. Infection during pregnancy may lead to spontaneous abortion, stillbirth or overt diseases in the neonate. Approximately 75% of congenitally infected newborns are symptomatic. However, nearly all children born with subclinical toxoplasmosis will develop adverse ocular or neurologic sequelae later in life (8, 11). Approximately 80-85% develops chorioretinitis and some may also experience blindness or mental retardation.

A variety of serologic tests for antibodies to T. gondii have been used as an aid in diagnosis of acute infection and to assess previous exposure to the organism. The more widely used tests include the SabinFeldman dye test, direct agglutination, indirect hemagglutination, latex agglutination, indirect immunofluorescence, and ELISA (9, 10).

KIT COMPONENTS

Individually packed test devices	Each device contains a strip of TOXO with colored conjugates and reactive reagents pre-spreaded at the corresponding regions.
Disposable pipettes	For adding specimens use.
Buffer	3 mL/vial. Phosphate buffered saline and preservative.
Package insert	For operation instruction.

 

PROCEDURE

Bring tests, specimens, buffer and/or controls to room temperature (15-30°C) before use.

1.Remove the test from its sealed pouch, and place it on a clean, level surface. Label the device with patient or control identification. To obtain a best result, the assay should be performed within one hour.

2.Transfer 10ul of serum/plasma to the specimen well of the device with a disposable pipette provided in the kit and add 2 drops of buffer,  then start the timer.

Avoid trapping air bubbles in the specimen well (S), and do not drop any solution in observation window.

As the test begins to work, you will see color move across the membrane. 

3.Wait for the colored band (s) to appear. The result should be read at 5 minutes. Do not interpret the result after 10 minutes.

INTERPRETATION OF ASSAY RESULT

PERFORMANCE CHARACTERISTICS

Table: TOXO Rapid Test vs. EIA Test

Relative Sensitivity: 98.21% (90.45%-99.95%)* Relative Specificity: 98.33% (91.06%-99.96%)* Overall Agreement: 98.28% (93.91%-99.79%)* *95% Confidence Interval			TOXO Rapid Test
			+	-	Total
	EIA Test	+	55	1	56
		-	1	59	60
			56	60	116

Zhuhai Encode Medical Engineering Co.,Ltd (herinafter referred to as Encode) was established in 1994, as one of the earliest
and largest manufacturers of in-vitro diagnostic field in China. Encode specializes in R&D, production and distribution of in-vitro diagnostic products. As a hi-tech and innovative enterprise, we have researched and developed series of microbiological diagnostic productds and immunology diagnostic rapid tests, which are used for diagnosis of infection disease, cardiac markers, tumor markers, fertility test, durgs of abuse and sexual transmitted disease.

Encode occupies a land of 15,000 m2 in Zhuhai. There are 2,000 GMP standard clean workshops of microbiology diagnostic products, colloidal gold diagnostic products and molecular with automatic manufacturing lines and passed the quality management system evaluation by SFDA and GDFDA.

Encode has established extensive cooperation with research centers in universtities, such as Lanzhou University, South China University of Technology, Jinan University and Shanghai Plumonary Hospital, etc. Whith strong R&D and technological innovation capability. Encode ranks leading level in terms of IVD industries field in China. We have also obtained ISO 13485:2003, ISO 9001:2001, CE and have been granted the title of national hi-tech enterprise.

Today, we provide medical products and health care solution to clients not only in China, but also worldwide, such as Europe, Africa, Middle East, South East, Asia etc.

With the experience and dedication of the scientific staffs, Zhuhai Encode Medical Engineering Co.,Ltd will continue our endeavor to provide professional in-vitro diagnostic products and health care solutions to the worldwide and make our contributions to the career of human health.