Keawe Kali

Prof. Nicole Pearson

BIOL 1615 [LAB]
3/31/2014
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Laboratory and Field Evaluation of a New Rapid Test for Detecting Wuchereria bancrofti
Antigen in Human Blood
Wuchereria bancrofti is a filarial nematode that causes Lymphatic filariasis (LF) which
is a deforming and disabling neglected tropical disease (NTD) that has been targeted for
elimination by the year 2020. LFs existence has been dated since the early 2000BC and
Wuchereria bancrofti is currently responsible for 90% of the LF disease burden in the world. To
define lymphatic filariasis, it is a parasitic disease caused by microscopic, thread-like worms.
The disease spreads from person-to-person by infectious mosquito bites and travel to the lymph
vessels where these worms grow into adults and only live in the lymph system. The importance
of the lymph system is that it maintains the body's fluid balance and fights infections.
People with the disease can suffer from lymphedema and elephantiasis and in men,
swelling of the scrotum, called hydrocele. Lymphatic filariasis is a leading cause of permanent
disability worldwide and in some communities, those infected are disfigured by the disease and
in turn are frequently shunned and rejected. In addition, affected people are usually unable to
work because of their disability, and this harms their families and their communities.
This researchs purpose is to test the new filarial antigen test, the Alere Filariasis Test
Strip, its probable advancement in testing endemic areas that require mass drug administration
(MDA) and for post-MDA surveillance, with the reference BinaxNOW Filariasis card test that
has been used for more than 10 years. This comparison research is important in determining
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whether or not the Global Program to Eliminate Lymphatic Filariasis (GPELF) will accept
this new filarial antigen testing as the better choice of the two while still under approved
guidelines.
CFA (circulating filarial antigen) tests that include microfilariae (Mf) detection in
human blood, developed into a commercial point-of-care (POC) immunochromatographic
(ICT) test in the late 1990s, allowing CFA testing to escape the confines of the research
laboratory and assume an important role as a tool for public health use. In the United States, the
test has been produced as the BinaxNOW Filariasis test by Alere Scarborough since 2000.
Although it is a valuable tool, its disadvantages are its short shelf-life of 3 months in ambient
temperatures in the tropics and the cost. Another problem with the test is its narrow time window
for reading the test result in less than 10 minutes after one closes the card to start the test. False-
positive results are common if the tests are read too late (after 20 minutes).
The improved CFA test, the Alere Filariasis Test Strip, is reported in the independent
evaluation, Laboratory and Field Evaluation of a New Rapid Test for Detecting Wuchereria
bancrofti Antigen in Human Blood, to prove and show the results that the new test has
significant advantages over its predecessor.
The experiments consist of using laboratory and field evaluations of the two filarial
antigen tests with the use of well-characterized panels of serum or plasma. The serum or plasma
were samples from human subjects with parasitologically proven helminthic (parasitic worm)
infections and control samples that were non-endemic for human filariasis and other human
helminthic infections. Following the manufacturers instructions, both the cards and test strips
were read by two independent readers at 10 minutes after samples were placed on the application
pads and at 24 hours after. Only the field evaluation included a 30 minute study. If there was an
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indecision between the two readers, a third reader made the final decision. The samples were
coded rather than being labeled and known to the readers. Analytical sensitivity of the two
antigen tests were compared by parallel testing of serial dilutions of a filarial antigen.
The laboratory results depicted that the strip produced stronger, sharper positive test lines
than the card and the test strip was more sensitive than the card test. With the minimum
concentration of antigen detected with the test strip, it was two to four times lower than the
minimum detected with the card test. Both of the test produced the same results for 220 of 222
samples that had valid results, aside from one invalid card, they both detected filarial
antigenemia in all 88 samples from subject with W. bancrofti microfilaremia. No positive results
were observed with either test for samples from subjects with no history of exposure to
bancroftian filariasis, regardless of whether they had other parasitic infections or rheumatoid
factor.
The field results consisted of sixteen test strips and one card test with invalid results.
These results were caused by testing a lesser volume of blood than 75 L or the blood was
partially clotted before testing. Other reasons for invalid occurrences were due to unexperienced
technicians as well but improvement occurred over time. The analytical sensitivity of the tests
were compared for 503 blood samples that had valid results for both test with the test strip
producing 26.5% more positive test results than the card. A 124/503 versus 98/503 result.
The final conclusion from the CFA test evaluation resulted with the Alere Filariasis Test
Strip being more advantageous than its predecessor, the BinaxNOW Filariasis test. The test strip
outperformed in both the laboratory and field study evaluations and in turn, the prediction of the
strip test being a better and improved CFA test has provided a positive conclusion.
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Works Cited
"Frequently Asked Questions (FAQs)." Centers for Disease Control and Prevention. Centers
for Disease Control and Prevention, 14 June 2013. Web. 30 Mar. 2014.
<http://www.cdc.gov/parasites/lymphaticfilariasis/gen_info/faqs.html>.
Public Health of Canada. Wuchereria Bancrofti. Pathogen Regulation Directorate, PUblic
Health Agency of Canada, 2010. Web. 31 Mar. 2014. <http://www.phac-aspc.gc.ca/lab-
bio/res/psds-ftss/wuchereria-bancrofti-eng.php>.
Weil, Gary J. "Laboratory and Field Evaluation of a New Rapid Test for Detecting Wuchereria
Bancrofti Antigen in Human Blood."The American Journal of Tropical Medicine and
Hygiene 89.1 (2013): 11-15. Web. 23 Jan. 2014.
<http://www.ajtmh.org/content/89/1/11.full.pdf+html>.