One Step Lymphatic Filariasis IgG/IgM Rapid Test Cassette(WB/S/P)

【INTENDED USE】

The Filariasis IgG/IgM Rapid Test is a lateral flow immunoassay for the simultaneous detection and differentiation of IgG and IgM anti-lymphatic filarial parasites (Wuchereria Bancrofti, Brugia Malayi and Brugia Timori) in human serum, plasma or whole blood. This test is intended to be used as a screening test and as an aid in the diagnosis of infection with lymphatic filarial parasites. Any reactive specimen with the Filariasis IgG/IgM Rapid Test must be confirmed with alternative testing method(s). For professional use only. For in vitro diagnostic use only.

【INTRODUCTION】

The lymphatic filariasis known as Elephantiasis, affects about 120 million people over 80 countries 1,2 . There are 3 types of these thread-like filarial worms 3 : Wuchereria bancrofti, which is responsible for 90% of the cases. Brugia malayi, which causes most of the remainder of the cases. Brugia timori, which also causes the disease. The disease is transmitted to humans by the bites of infected mosquitoes within which the microflariae sucked from an infected human subject develops into third-stage larvae. Generally, repeated and prolonged exposure to infected larvae is required for establishment of human infection. The definitive parasitologic diagnosis is the demonstration of microflariae in blood samples 4 . However, this gold standard test is restricted by the requirement for nocturnal blood collection and lack of adequate sensitivity. Detection of circulating antigens is commercially available. Its usefulness is limited for W. bancrofti5 . In addition, microfilaremia and antigenemia develop from months to years after exposure. Antibody detection provides an early means to detect filarial parasite infection. Presence of IgM to the parasite antigens suggest current infection, whereas, IgG corresponds to late stage of infection or past infection 6 . Furthermore, identification of conserved antigens allows 'panfilaria' test to be applicable. Utilization of recombinant proteins eliminates cross-reaction with individuals having other parasitic diseases 7 . The Filariasis IgG/IgM Rapid Test uses conserved recombinant antigens to simultaneously detect IgG and IgM to the W. bancrofti and B. malayiparasites without the restriction on specimen collection.

【MAIN CONTENTS】

• Rapid test cassette with desiccant

• Buffer

• Disposable pipettes

• Package insert

【PRECAUTIONS】

• For professional in vitro diagnostic use only.

• Do not use after the expiration date indicated on the package. Do not use the test if the foil pouch is damaged. Do not reuse tests.

• This kit contains products of animal origin. Certified knowledge of the origin and/or sanitary state of the animals does not completely guarantee the absence of transmissible pathogenic agents. It is therefore, recommended that these products be treated as potentially infectious, and handled by observing usual safety precautions (e.g., do not ingest or inhale).

• Avoid cross-contamination of specimens by using a new specimen collection container for each specimen obtained.

• Read the entire procedure carefully prior to testing.

• Do not eat, drink or smoke in the area where the specimens and kits are handled. Handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout the procedure and followstandardproceduresfor the proper disposal of specimens. Wear protective clothingsuchas laboratory coats, disposable gloves and eye protectionwhenspecimens are assayed.

• Humidity and temperature can adversely affect results.

• Used testing materials should be discarded accordingtolocalregulations.

【DIRECTION OF USE】

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

1. Remove the test from its sealed pouch, and place it onaclean,level surface. Label the test with patient or control identification.Forbest results, the assay should be performed within one hour.

2. Transfer 1 drop of whole blood, serumor plasma specimentothespecimen well (S) of the device with the provideddisposablepipette, then add 1 drop of buffer and start the timer.

3. Wait for colored line(s) to appear. Interpret the test resultsin15minutes. Do not read results after 20 minutes.

【INTERPRETATION OF RESULTS】

Positive : IgG Positive: Both IgG test region (G) and control region appear color line. IgM Positive: Both IgM test region (M) and control region appear color line. IgG/IgM Positive: Both test region (G and M) and control region appear color line.

Negative : Only one color line appears on the control region (C). Invalid: No visible line at all, or there is a visible line only in the test region and not in the control region. Repeat with a new test kit.

【STORAGE AND STABILITY】

• Store at 2 ~ 30 º C in the sealed pouch for 24 months.

• Keep away from direct sunlight, moisture and heat.

• DO NOT FREEZE.

【QUALITY CONTROL】

• Internal procedural controls are included in the test. A colored band appearing in the control region (C) is considered an internal positive procedural control, confirming sufficient specimen volume and correct procedural technique.

• External controls are not supplied with this kit. It is recommended that positive and negative controls be tested as a good laboratory practice to confirm the test procedure and to verify proper test performance.

【STORAGE AND STABILITY】

• Store at 2 ~ 30 º C in the sealed pouch for 24 months.

• Keep away from direct sunlight, moisture and heat.

• DO NOT FREEZE.

【PERFORMANCE CHARACTERISTICS】

Relative Sensitivity >96%;

Relative Specificity >99%;

Overall agreement >99%.

For further operation or performance details, please refer to final instruction manual.