Focus Diagnostics

Cypress, CA, United States

Focus Diagnostics

Cypress, CA, United States

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Burgos-Rivera B.,Centers for Disease Control and Prevention | Lee A.D.,Centers for Disease Control and Prevention | Bowden K.E.,Centers for Disease Control and Prevention | Faulkner A.E.,Centers for Disease Control and Prevention | And 5 more authors.
Journal of Clinical Microbiology | Year: 2015

While PCR is the most common method used for detecting Bordetella pertussis in the United States, most laboratories use insertion sequence 481 (IS481), which is not specific for B. pertussis; therefore, the relative contribution of other Bordetella species is not understood. The objectives of this study were to evaluate the proportion of other Bordetella species misidentified as B. pertussis during a period of increased pertussis incidence, determine the level of agreement in Bordetella species detection between U.S. commercial laboratories and the CDC, and assess the relative diagnostic sensitivity of CDC's PCR assay when using a different PCR master mix. Specimens collected between May 2012 and May 2013 were tested at two U.S. commercial laboratories for B. pertussis and B. parapertussis detection. Every fifth specimen positive for IS481 and/or IS1001 with cycle threshold (CT) values of ≤35 was sent to CDC for PCR testing that identifies Bordetella species. Specimens with indeterminate or negative results in the CDC PCR were tested using an alternate PCR master mix. Of 755 specimens, there was agreement in species identification for 83.4% (n=630). Of the specimens with different identifications (n=125), 79.2% (n=99) were identified as indeterminate B. pertussis at CDC. Overall, 0.66% (n = 5) of the specimens were identified as B. holmesii or B. bronchiseptica at CDC. Of 115 specimens with indeterminate or negative results, 46.1% (n=53) were B. pertussis positive when tested by an alternate master mix, suggesting a possible increase in assay sensitivity. This study demonstrates good agreement between the two U.S. commercial laboratories and CDC and little misidentification of Bordetella species during the 2012 U.S. epidemic. Copyright © 2015, American Society for Microbiology. All Rights Reserved.


Carson P.J.,University of North Dakota | Carson P.J.,Sanford Health | Prince H.E.,Focus Diagnostics | Biggerstaff B.J.,Centers for Disease Control and Prevention | And 3 more authors.
Journal of Clinical Microbiology | Year: 2014

West Nile virus (WNV) is now endemic in the United States. Protection against infection is thought to be conferred in part by humoral immunity. An understanding of the durability and specificity of the humoral response is not well established. We studied the magnitude and specificity of antibody responses in 370 WNV-seropositive blood donors. We also recalled 18 donors who were infected in 2005 to compare their antibody responses at 6 months following infection versus at 5 years postinfection. There were no significant differences in IgG antibody levels based on age, sex, or recent infection (as evidenced by IgM positivity). Specific antibody responses by viral plaque reduction neutralization testing (PRNT) were seen in 51/54 subjects evaluated. All donors who were seropositive in 2005 remained seropositive at 5 years and maintained neutralizing antibodies. IgG levels at 5 years postinfection showed fairly minimal decreases compared with the paired levels at 6 months postinfection (mean of paired differences, 0.54 signal-to-cutoff ratio (S/CO) units [95% confidence interval {CI},0.86 to0.21 S/CO units]) and only minimal decreases in PRNT titers. WNV induces a significant antibody response that remains present even 5 years after infection. Copyright © 2014, American Society for Microbiology.


Lindsey N.P.,Centers for Disease Control and Prevention | Prince H.E.,Focus Diagnostics | Kosoy O.,Centers for Disease Control and Prevention | Laven J.,Centers for Disease Control and Prevention | And 3 more authors.
American Journal of Tropical Medicine and Hygiene | Year: 2015

Chikungunya virus is an emerging threat to the United States because humans are amplifying hosts and competent mosquito vectors are present in many regions of the country. We identified laboratory-confirmed chikungunya virus infections with diagnostic testing performed in the United States from 2010 through 2013.We described the epidemiology of these cases and determined which were reported to ArboNET. From 2010 through 2013, 115 laboratoryconfirmed chikungunya virus infections were identified. Among 55 cases with known travel history, 53 (96%) reported travel to Asia and 2 (4%) to Africa. No locally-acquired infections were identified. Six patients had detectable viremia after returning to the United States. Only 21% of identified cases were reported to ArboNET, with a median of 72 days between illness onset and reporting. Given the risk of introduction into the United States, healthcare providers and public health officials should be educated about the recognition, diagnosis, and timely reporting of chikungunya virus disease cases. Copyright © 2015 by The American Society of Tropical Medicine and Hygiene.


Loeffelholz M.J.,University of Texas Medical Branch | Prince H.E.,Focus Diagnostics
Clinical and Vaccine Immunology | Year: 2015

This study evaluated an enzyme immunoassay, a multiplex bead immunoassay (MBIA), and the anticomplement immunofluorescence (ACIF) test for detecting varicella-zoster virus IgG antibodies in sera from medical center students and employees. The agreement between methods was ≥95%. The MBIA was less sensitive than was the ACIF test, with a negative predictive value of 66.7%. Copyright © 2015, American Society for Microbiology. All Rights Reserved.


Prince H.E.,Focus Diagnostics | Lape-Nixon M.,Focus Diagnostics | Novak-Weekley S.M.,Southern California Permanente Medical Group Regional Reference Laboratories
Clinical and Vaccine Immunology | Year: 2014

The measurement of cytomegalovirus (CMV) IgG avidity accurately discriminates recent and past CMV infections. We sought to determine if the Wampole Laboratories CMV IgG enzyme immunoassay (EIA) could be modified to measure avidity. The evaluation panel consisted of 156 serum samples we used in 2002 to validate a laboratory-developed EIA, in which 78 serum samples exhibited low avidity, 7 exhibited intermediate avidity, and 71 exhibited high avidity. The qualitative agreement between the two avidity assays was 94% (147/156); all 9 sera with discordant results exhibited intermediate avidity in one of the assays. The avidity index (AI) values in the two assays showed excellent correlation (r = 0.96, P < 0.0001). The definition of high avidity was verified for the Wampole assay by demonstrating high avidity in 91/93 (98%) recently collected CMV IgG-positive/IgM-negative serum samples. The performance of the Wampole avidity assay in a reference laboratory setting was assessed using 470 consecutive serum samples submitted for CMV IgG avidity testing. Surprisingly, 101 serum samples were negative when screened for CMV IgG using the Wampole kit per the package insert; 98 of these 101 serum samples were tested using a CMV IgG chemiluminescent immunoassay, and only 5 were positive. Of the 369 CMV IgG-positive samples, 6% exhibited low IgG avidity, 6% exhibited intermediate avidity, and 88% exhibited high avidity; CMV IgM detection rates were inversely related to AI levels. These findings show that (i) the Wampole CMV IgG EIA can be modified to measure CMV IgG avidity, (ii) many samples are apparently submitted for avidity testing without knowledge of their CMV IgG status, and (iii) most CMV IgG-positive sera submitted for avidity testing exhibit high avidity. Copyright © 2014, American Society for Microbiology. All Rights Reserved.


Lee P.,Focus Diagnostics | Plavina T.,Biogen Idec | Castro A.,Focus Diagnostics | Berman M.,Biogen Idec | And 4 more authors.
Journal of Clinical Virology | Year: 2013

Background: JC virus (JCV) infection is a prerequisite for development of progressive multifocal leukoencephalopathy (PML). The development and validation of a two-step enzyme-linked immunosorbent assay (ELISA) that detects JCV antibodies in human serum or plasma and its clinical utility for stratification of PML risk have been described. Objective: To develop a second-generation JCV antibody ELISA kit with improved assay performance characteristics. Study design: The assay design was optimized by pre-coating the JC virus-like particles (VLP) on microtiter plates. Assay cut-points were statistically established using sera from >1300 multiple sclerosis patients from natalizumab clinical studies. The assay was analytically validated and then used to determine the presence of JCV antibodies in both treatment-naïve and natalizumab-treated MS patients, as well as in natalizumab-treated PML patients. Results: An improved assay for detection of JCV antibodies in human serum and plasma was developed. Key enhancements included improved delineation and reproducibility of low JCV antibody responses and assay ease of use. The assay was validated, demonstrating good agreement with the original two-step JCV antibody ELISA, and similar seroprevalence of 50%-60%. Samples from 63 natalizumab-treated PML patients collected 6-180 months prior to PML diagnosis tested JCV antibody positive. One patient tested JCV antibody negative 15 months prior to PML diagnosis but JCV antibody positive 2 months prior to PML diagnosis. Conclusions: The validated second-generation JCV antibody ELISA offers improved assay design as a kit and enhanced performance characteristics that advance routine clinical use of the assay as a PML risk stratification tool. © 2013 Elsevier B.V.


Palle L.,Focus Diagnostics | Reddy B.,Focus Diagnostics | Reddy J.,Focus Diagnostics
Skeletal Radiology | Year: 2010

Objective: To evaluate the correlation between anterior cruciate ligament (ACL) tear and straightened, vertically oriented lateral collateral ligament (LCL). Materials and methods: This study included 556 patients who underwent MRI of the knee and were divided into three subsets based on ACL morphology. Subset 1 included patients with unequivocal normal ACL. Subset 2 included patients with unequivocal ACL tears. Subset 3 included patients with doubtful ACL who underwent arthroscopy. MR images were reviewed and sensitivity and specificity of vertically oriented LCL as an indirect sign of ACL tear were calculated. Results: The MRI results were as follows: subset 1, out of 282 patients, 270 had oblique LCL and 12 demonstrated vertical LCL; subset 2, out of 212 patients, 189 demonstrated vertical LCL and 23 revealed oblique LCL; subset 3, out of 62 patients, 28 patients with vertical orientation of LCL had a possible ACL tear. Patients with oblique LCL orientation (34) were reported as probably having normal ACL. On comparison with arthroscopy, in 28 patients who we reported as having possible ACL tears, there were 17 patients with torn ACL. The rest of the 11 patients revealed no ACL tears. In the group of 34 patients in whom we reported possible normal, arthroscopy-confirmed tear in 5 patients. Sensitivity and specificity of vertical LCL as an indirect sign of ACL tear was found to be 88% and the specificity 92.85%. Conclusion: Vertically oriented LCL is a useful indirect MRI sign of ACL tear and aids in making a diagnosis, when ACL appearance is equivocal. © 2010 ISS.


Prince H.E.,Focus Diagnostics | Lape-Nixon M.,Focus Diagnostics | Patel H.,Focus Diagnostics | Yeh C.,Focus Diagnostics
Clinical and Vaccine Immunology | Year: 2010

All reported cases of WA1 babesiosis have occurred in the Pacific coast region of the United States, suggesting that WA1 is limited to this geographic area. However, we detected WA1 IgG in 27% of clinical sera sent to our laboratory for WA1 IgG testing from across the United States over a 2-year period, suggesting that exposure to WA1 or a closely related organism occurs outside Pacific coast states. We sought to determine if this high WA1 IgG detection rate among clinical specimens merely reflects WA1 seroprevalence outside the Pacific region. WA1 IgG, as well as Babesia microti IgG, was measured in 900 blood donor specimens from 9 states. Overall seroprevalence was 2.0% for WA1 and 0.4% for B. microti; regional seroprevalences ranged from 0 to 4% and 0 to 2%, respectively. Additional studies were performed to determine if WA1 IgG reactivity was attributable to polyclonal B-cell activation associated with acute Epstein-Barr virus (EBV) infection; 40 WA1 IgG-positive clinical sera and the 18 WA1 IgG-positive blood donor specimens were all negative for EBV capsid antigen (EBVCA) IgM (a marker of acute EBV infection), and 40 EBVCA IgM-positive sera were all negative for WA1 IgG. These findings indicate that the high WA1 IgG detection rate among clinical specimens does not simply reflect the national WA1 seroprevalence among blood donors or nonspecific reactivity due to acute EBV infection. Rather, the findings suggest that infection with WA1 or a related organism is more common than indicated by the literature and is not limited to Pacific coast states. Copyright © 2010, American Society for Microbiology. All Rights Reserved.


Lalitha P.,Focus Diagnostics | Reddy M.Ch.B.,Focus Diagnostics | Reddy K.J.,Focus Diagnostics
American Journal of Neuroradiology | Year: 2011

JXG is a disorder classified under histiocytosis. It usually affects children and commonly presents with skin lesions. Intracranial lesions are uncommon and usually solitary. We present the case of a child who had extensive intracranial involvement with multiple enhancing solid lesions in the cerebellum, Brain stem, thalami, and bilateral cerebral hemispheres on MR imaging.


Palle L.,Focus Diagnostics | Reddy M.C.H.B.,Focus Diagnostics | Reddy K.,Focus Diagnostics
Indian Journal of Radiology and Imaging | Year: 2010

Aim: To define a range of apparent diffusion coefficient values in spinal tuberculosis and to evaluate the sensitivity of diffusion-weighted magnetic resonance imaging (DW-MRI) and apparent diffusion coefficient values in patients of spinal tuberculosis. Materials and Methods: This study was conducted over a period of 20 months and included 110 patients with a total of 230 vertebral bodies. The study was performed in two parts. The first part included all patients of known tuberculosis and patients with classical features of tuberculosis. The second part included patients with spinal pathology of indeterminate etiology. All the patients underwent a routine MRI examination along with diffusion sequences. The apparent diffusion coefficient (ADC) values were calculated from all the involved vertebral bodies. Results: The mean ADC value of affected vertebrae in first part of the study was found to be 1.4 0.20 10 -3 mm 2 /s. This ADC value was then applied to patients in the second part of study in order to determine its ability in predicting tuberculosis. This range of ADC values was significantly different from the mean ADC values of normal vertebrae and those with metastatic involvement. However, there was an overlap of ADC values in a few tuberculous vertebrae with the ADC values in metastatic vertebrae. Conclusion: We found that DW-MRI and ADC values may help in the differentiation of spinal tuberculosis from other lesions of similar appearance. However, an overlap of ADC values was noted with those of metastatic vertebrae. Therefore diffusion imaging and ADC values must always be interpreted in association with clinical history and routine MRI findings and not in isolation.

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