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Duke University Medical Center Research

In 2005, an independent study was done to determine how the performance of ALBAclone? blood grouping reagents compared with the performance of marketed products. The findings of this research are reported below.

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Test ReagentReference Reagent 1Sample SizeDuke ResultsDownload Details
ALBAclone® Anti-A (Z001U) Ortho/MTS Anti-A* 505 No typing discrepancies were identified Download
ALBAclone® Anti-B (Z015U) Ortho/MTS Anti-B* 505 No typing discrepancies were identified Download
ALBAclone® Anti A,B (Z023U) Ortho/MTS Anti-A, Anti-B* 505 No typing discrepancies were identified Download
ALBAclone® Anti-D alpha (Z031U) Ortho/MTS Anti-D* 405 No typing discrepancies were identified with ALBAclone® products** Download
ALBAclone® Anti-D beta (Z036U) Ortho/MTS Anti-D* 405 No typing discrepancies were identified with ALBAclone® products** Download
ALBAclone® Anti-D delta (Z039U) Ortho/MTS Anti-D* 405 No typing discrepancies were identified with ALBAclone® products** Download
ALBAclone® Anti-D blend (Z041U) Ortho/MTS Anti-D 405 No typing discrepancies were identified with ALBAclone® products** Download
ALBAclone® Anti-c blend (Z083U) Ortho/MTS Anti-c 200 No typing discrepancies were identified Download
ALBAclone® Anti-Lub (Z223U) Anti-Lub patient sample 100 No typing discrepancies were identified† Download
ALBAclone® Anti-E (Z073U) Ortho Anti-E 200 No typing discrepancies were identified Download
ALBAclone® Anti-M (Z171U) Gammaclone® Anti-M 100 No typing discrepancies were identified Download
ALBAclone® Anti-N (Z176U) Immucor Anti-N 100 No typing discrepancies were identified Download
ALBAclone® Anti-k (Z137U) Ortho Anti-k 100 No typing discrepancies were identified Download
ALBAclone® Anti-Lea (Z212U) Ortho Anti-Lea 100 No typing discrepancies were identified with ALBAclone® products†† Download
ALBAclone® Anti-Leb (Z217U) Ortho Anti-Leb 100 No typing discrepancies were identified with ALBAclone® products‡ Download

* Reagents were from Lot 403715. For ALBAclone Anti-A (Z001), another reagent was also tested: Immucor Anti-A Lot #101640.

** In one sample with mixed field agglutination, the Ortho reference agent produced equivocal results, while the ALBAclone® product produced unequivocal results.

† When the test results were compared with the performance of the comparator reagent, no typing discrepancies were identified although no result was recorded for the reference reagent with sample 1007. The reagent performed as specified and no unexpected reactions were observed.

†† When the test results were compared with the comparator reagent, one test was repeated as the reference failed to react originally. The results were comparable on repeat. The reagent performed as specified and no unexpected reactions were observed.

‡ One test was repeated as the test failed to react originally. The results were comparable on repeat. Another sample gave a discrepant result; however, the result obtained with the ALBAclone® antisera was confirmed with Immucor® Anti-Leb.

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