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Cypress, CA, United States

Patent
Focus Diagnostics Inc. | Date: 2014-04-29

The invention provides methods and compositions for rapid, sensitive, and highly specific nucleic acid-based (e.g., DNA based) detection of a BK virus in a sample. In general, the methods involve detecting a target nucleic acid having a target sequence of a conserved region of BK viral genomes. The invention also features compositions, including primers, probes, and kits, for use in the methods of the invention.


Systems and methods for processing sample processing devices. The system can include a sample processing device comprising a detection chamber, a motor configured to rotate the sample processing device about an axis of rotation, and an optical module operatively positioned relative to the sample processing device and configured to determine whether a selected volume of material is present in the detection chamber of the sample processing device. The method can include rotating the sample processing device about an axis of rotation, and determining whether a selected volume of material is present in the detection chamber, while rotating the sample processing device. In some embodiments, determining whether a selected volume of material is present can be performed by optically interrogating the detection chamber for an optical property of the material.


Prince H.E.,Focus Diagnostics Inc. | Lieberman J.M.,Focus Diagnostics Inc. | Cherry J.D.,University of California at Los Angeles
Clinical and Vaccine Immunology | Year: 2012

During the period 2008 to 2010, we identified 11,386 serum samples with increased (positive) levels of antibodies recognizing Bordetella pertussis antigens. We sought to characterize the distribution of positive antibody result patterns in relation to patient age. IgG and IgA antibodies recognizing pertussis toxin (PT) and filamentous hemagglutinin (FHA) were quantified using a multianalyte immunodetection assay. Four mutually exclusive positive result patterns were observed: increased FHA antibodies only, increased PT IgA but not IgG, increased PT IgG but not IgA, and increased PT IgG and IgA. In patients <21 years old, the predominant pattern was increased PT IgG but not IgA, whereas in patients ≥21 years old, it was increased FHA antibodies only. The proportion of positive serum samples exhibiting increased PT IgA but not IgG was <20% in all age categories but showed a stepwise rise with age. The proportions of positive serum samples exhibiting increased PT IgG and IgA were similar (26 to 32%) in the age categories spanning 11 to 60 years of age but lower in the <11- and >60-year-old groups. In 3 of 5 age categories, a significant rise in the proportion of positive serum samples exhibiting increased FHA antibodies only occurred in 2010. Patterns of positive B. pertussis antibody results varied with age. The predominance of increased FHA antibodies only in patients >20 years old suggests that many adults thought to have B. pertussis infections actually have other infections that induce FHA-reactive antibodies. Similarly, the 2010 rise in the frequency of increased FHA antibodies only in some age groups suggests an increase in non-B. pertussis infections. Copyright © 2012, American Society for Microbiology. All Rights Reserved. Source


Selvaraju S.B.,University of Rochester | Tierney D.,Focus Diagnostics Inc. | Leber A.L.,Nationwide Childrens Hospital | Patel A.,Le Bonheur Childrens Medical Center | And 3 more authors.
Diagnostic Microbiology and Infectious Disease | Year: 2014

In this study, we evaluated FOCUS diagnostic's Flu A/B & RSV direct kit (Direct Disc assay), designed to detect influenza (FLU) and respiratory syncytial viruses (RSV) directly in clinical specimens without nucleic acid extraction. This novel 'sample-to-answer', nucleic acid extraction-independent assay uses a unique disc to process, amplify, and detect viral targets in up to 8 specimens at a time. The performance of this assay for detecting FLU and RSV viruses was compared to the traditional methods (culture and/or direct florescent antibody testing) using 945 nasopharyngeal swab specimens. In addition, a total of 150 consecutive clinical specimens positive for FLU (FLU A=50, FLU B=50) or RSV (n=50) were tested in parallel using the novel Direct Disc assay and FOCUS diagnostic's nucleic acid extraction-dependent assay to assess their relative performance. Compared to the traditional methods, the overall (prospective. +. retrospective) positive/negative percent agreement was determined to be 96.6%/98.1% for FLU A, 98.4%/99.9% for FLU B, and 99.3%/98.8% for RSV. Compared to the nucleic acid extraction-dependent assay, the positive percent agreement was 90% (n = 45/50) for FLU A, 92% (n = 46/50) for FLU B, and 98% (n=49/50) for RSV. Overall, the Direct Disc assay showed good agreement with both traditional methods and nucleic acid extraction-dependent assay. Although we encountered some failures compared to the nucleic acid extraction-dependent assay, these limitations must be balanced against the substantial advantages of the extraction-free nature of this assay and rapid turnaround time. © 2014 Elsevier Inc. Source


Prince H.E.,Focus Diagnostics Inc. | Matud J.L.,Focus Diagnostics Inc.
Clinical and Vaccine Immunology | Year: 2011

Dengue virus IgM persistence was estimated using follow-up sera from 98 patients (60 with primary infections and 38 with secondary infections) whose first-specimen IgM index was strongly positive, suggesting recent disease onset. Regression analysis of the follow-up IgM index versus days between samples yielded a trend line that reached the cut-point index (1.10) at 179 days for the primary infection group and 139 days for the secondary infection group. This difference reflected significantly higher first-sample IgM indices in primary infections than in secondary infections rather than differences in IgM decay rates. Copyright © 2011, American Society for Microbiology. All Rights Reserved. Source

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