Chagas STAT-PAK® Assay
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Chagas STAT-PAK® Assay* Accurate, Rapid, Point-of-Care Chagas Testing The Chembio Chagas STAT-PAK® Assay is a single-use immunochromatographic test for the detection of antibodies to T. cruzi in fingerstick, venous whole blood, serum, or plasma. The test is a rapid (15 minutes) point-of-care (POC) diagnostic tool. Results are interpreted visually. Quality accurate results on a Point-of-Care delivery platform Rapid and simple, 15 minutes to perform The Chagas STAT-PAK® Assay contains recombinant antigens B13, 1F8 and H49/JL7 Room temperature storage and procedure; no refrigeration needed Results can easily be read manually Making rapid diagnosis while a patient is still at the testing location provides a clear benefit: treatment early in the course of disease, thus leading to improved outcome. The test has up to 24-month shelf life when stored at room temperature. A.O. Luquetti et al., Chagas’ Disease Diagnosis: A Multicentric Evaluation of Chagas Stat-Pak, a Rapid Immunochromatographic Assay with Recombinant Proteins of Trypanosoma cruzi, Diagnostic Microbiology and Infectious Disease, Feb 2003, 46 (2003) 265–271 Ponce et al., Validation of a Rapid and Reliable Test for Diagnosis of Chagas’ Disease by Detection of Trypanosoma cruzi-Specific Antibodies in Blood of Donors and Patients in Central America, Journal Clinical Microbiology, Oct. 2005, p. 5065–5068 3661 Horseblock Road, Medford, NY 11763 USA Tel: (631) 924-1135 Fax: (631) 924-2065 E-mail: info@chembio.com Website: www.chembio.com

LABEL the test with patient ID number. 2 COLLECT sample (serum or plasma) using a 5 pl pipettor or 10 pl Microsafe' tube (fingerstick.) 3 TOUCH Microsafe' tube to the center of sample well, HOLDING vertically. Slowly ADD 6 drops of buffer HOLDING vial vertically. 5 READ test results at 15 minutes. See "Possible Results." Possible Results + POSITIVE RESULT Control - NEGATIVE RESULT Control > ( *This product is not FDA cleared