Rx Only ® cobas Babesia Nucleic acid test ® for use on the cobas 6800/8800 Systems For in vitro diagnostic use ® cobas Babesia – 480 P/N: 08244049190 cobas® Babesia Control Kit P/N: 08460981190 cobas® NHP Negative Control Kit P/N: 07002220190 cobas omni MGP Reagent P/N: 06997546190 cobas omni Specimen Diluent P/N: 06997511190 cobas omni Lysis Reagent P/N: 06997538190 cobas omni Wash Reagent P/N: 06997503190 cobas® Babesia Table of contents Intended use ............................................................................................................................ 4 Summary and explanation of the test ................................................................................. 4 Reagents and materials ......................................................................................................... 7 cobas® Babesia reagents and controls ....................................................................................................... 7 cobas omni reagents for sample preparation ........................................................................................ 10 Reagent storage and handling requirements ......................................................................................... 11 Additional materials required ................................................................................................................. 12 Instrumentation and software required ................................................................................................. 12 Precautions and handling requirements .........................................................................13 Warnings and precautions ...................................................................................................................... 13 Reagent handling ...................................................................................................................................... 14 Good laboratory practice ......................................................................................................................... 14 Sample collection, transport and storage ........................................................................15 Living donor samples ............................................................................................................................... 15 Instructions for use ...............................................................................................................17 Procedural notes ....................................................................................................................................... 17 Running cobas® Babesia .......................................................................................................................... 17 Results ..................................................................................................................................... 18 Quality control and validity of results .................................................................................................... 18 Interpretation of results ........................................................................................................................... 19 Procedural limitations.............................................................................................................................. 19 Non-clinical performance evaluation ...............................................................................20 Key performance characteristics ............................................................................................................. 20 Limit of Detection (LoD) ................................................................................................................ 20 Genotype verification ...................................................................................................................... 22 Analytical specificity ........................................................................................................................ 22 Cross contamination ....................................................................................................................... 23 08487057001-01EN Doc Rev. 1.0 2 cobas® Babesia Clinical performance evaluation ........................................................................................24 Clinical sensitivity .................................................................................................................................... 24 Clinical specificity .................................................................................................................................... 24 Individual testing results ................................................................................................................. 24 Reproducibility ......................................................................................................................................... 26 Additional information .........................................................................................................30 Key test features ........................................................................................................................................ 30 Symbols ...................................................................................................................................................... 31 Manufacturer and distributors ............................................................................................................... 32 Trademarks and patents .......................................................................................................................... 32 Copyright ................................................................................................................................................... 32 References .................................................................................................................................................. 33 Document revision ................................................................................................................................... 34 08487057001-01EN Doc Rev. 1.0 3 cobas® Babesia Intended use The cobas® Babesia test for use on the cobas® 6800 and cobas® 8800 Systems is a qualitative in vitro nucleic acid screening test for the direct detection of Babesia (B. microti, B, duncani, B. divergens, and B. venatorum) DNA and RNA in whole blood samples from individual human donors, including donors of whole blood and blood components, and other living donors. This test is also intended for use to screen organ and tissue donors when donor samples are obtained while the donor’s heart is still beating. Whole blood samples from all donors may be screened as individual samples. This test is not intended for use as an aid in diagnosis of Babesia infection. This test is not intended for use on samples of cord blood. This test is not intended for use on cadaveric blood specimens. Summary and explanation of the test Background Babesia is a protozoan parasite that infects red blood cells (RBCs) and may cause a disease known as babesiosis. Babesiosis may be treated with antibiotics and anti-parasitics. No vaccine is available.1 More than a hundred species of Babesia have been identified. The bite of a tick is the usual means through which Babesia is transmitted, but Babesia may also be transmitted by transfusion or from mother to child during pregnancy or delivery. The vast majority of transfusion-associated cases in the United States (US) are due to Babesia microti, and approximately 2% of reported cases are due to Babesia duncani.2 Tick-borne transmission of B. microti mainly occurs in 7 states in the Northeast (Connecticut, Massachusetts, New Hampshire, New York, and Rhode Island) and the upper Midwest (Minnesota and Wisconsin). Transmission peaks in the warmer months of the year, but, because there are transfusion and congenital risks of transmission, the infection can occur at any time. B. duncani is endemic to the West Coast. Two other species, B. divergens and B. venatorum, also cause human disease but are not endemic in the US. Babesiosis can be transmitted in areas that are not considered at high risk for transmission of the parasite because blood donors may travel to endemic areas. The number of cases of babesiosis reported in the US in 2011 was 1,124, of which 10 were transfusion-associated.3 One hundred and sixty-two cases of transfusion-associated babesiosis were reported from 1979-2009, with the rate apparently increasing over time.2 Although this statistic likely significantly underestimates the true rate of transfusion-associated babesiosis, it makes Babesia one of the most-commonly transmitted transfusion-associated infection in the US.4 Although a history of babesiosis is a basis for indefinite deferral as a blood donor, donors may be unaware that they carry the parasite, may have asymptomatic parasitemia, and may remain infectious for a year or more. Further, the parasite is viable in blood products. The majority of transfusion-associated cases are associated with erythrocytes (including leukoreduced or irradiated units), with a handful of cases due to whole blood-derived platelet transfusion. Prospective testing of 89,153 blood donations in endemic areas of the US yielded a 0.38% positive rate for Babesia.5 08487057001-01EN Doc Rev. 1.0 4 cobas® Babesia Most cases of babesiosis are asymptomatic, and symptoms, if they occur