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Journal of Clinical Microbiology, January 2003, p. 209-212, Vol. 41, No. 1
0095-1137/03/$08.00+0     DOI: 10.1128/JCM.41.1.209-212.2003
Copyright © 2003, American Society for Microbiology. All Rights Reserved.

Commercial Assay for Detection of Giardia lamblia and Cryptosporidium parvum Antigens in Human Fecal Specimens by Rapid Solid-Phase Qualitative Immunochromatography

Lynne S. Garcia,1* Robyn Y. Shimizu,2 Susan Novak,3 Marilyn Carroll,4 and Frank Chan5

LSG & Associates, Santa Monica, California 90402,1 Department of Pathology and Laboratory Medicine, University of California, Los Angeles, California 90095,2 Microbiology, Kaiser Permanente, North Hollywood, California 91605,3 Turner Laboratory, Torrance, California 90745,4 Microbiology, Children's Hospital of Eastern Ontario, Ottawa, Ontario K1H 8L1, Canada5

Received 27 June 2002/ Returned for modification 6 August 2002/ Accepted 2 September 2002

The ImmunoCard STAT! Cryptosporidium/Giardia rapid assay (Meridian Bioscience, Inc.) is a solid-phase qualitative immunochromatographic assay that detects and distinguishes between Giardia lamblia and Cryptosporidium parvum in aqueous extracts of human fecal specimens (fresh, frozen, unfixed, or fixed in 5 or 10% formalin or sodium acetate-acetic acid-formalin). By using specific antibodies, antigens specific for these organisms are isolated and immobilized on a substrate. After the addition of appropriate reagents, a positive test is detected visually by the presence of a gray-black color bar (regardless of the intensity) next to the organism name printed on the test device. A control is included in the device. Steps include tube preparation (buffer, patient specimen, conjugates A and B), testing (addition of sample onto the test device), and visual reading (total time, 12 min). Test performance was evaluated with known positive and negative stool specimens (170 specimens positive for Giardia and 231 specimens negative for Giardia) (85 specimens positive for Cryptosporidium and 316 specimens negative for Cryptosporidium); they were tested with trichrome, iron-hematoxylin, or modified acid-fast stains or the Meridian Bioscience, Inc., Giardia/Cryptosporidium Merifluor combination reagent; specimens with discrepant results were retested by using the Merifluor combination reagent. On the basis of the results of the reference methods, the sensitivities, specificities, and positive and negative predictive values were as follows: for G. lamblia, 93.5, 100, 100, and 95.5%, respectively; for C. parvum, 98.8, 100, 100, and 99.7%, respectively. False-negative results for G. lamblia were obtained with specimens with low parasite numbers (n = 7) or specimens containing trophozoites only (n = 3); one specimen with a false-negative result contained numerous cysts. The one specimen false negative for C. parvum was confirmed to be positive by immunofluorescence. No cross-reactivity was seen with 10 different protozoa (152 challenges), nine different helminths (35 challenges), or human cells (4 challenges) found in fecal specimens. This rapid test system may be very beneficial in the absence of trained microscopists; however, for patients who remain symptomatic after a negative result, the ova and parasite examination and special stains for other coccidia and the microsporidia should always remain options.

* Corresponding author. Mailing address: LSG & Associates, 512 12th St., Santa Monica, CA 90402-2908. Phone: (310) 393-5059. Fax: (310) 899-9722. E-mail: Lynnegarcia2{at}earthlink.net.

Journal of Clinical Microbiology, January 2003, p. 209-212, Vol. 41, No. 1
0095-1137/03/$08.00+0     DOI: 10.1128/JCM.41.1.209-212.2003
Copyright © 2003, American Society for Microbiology. All Rights Reserved.



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