【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.
