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    • Ropivacaine HCl A two way chi square test was used to determ

    2022-07-08

    A two-way chi-square test was used to determine statistically significant differences between corresponding frequencies of GT results for the 2 testing periods. A p value of <0.05 was considered statistically significant for all comparisons.
    Results Distribution of HCV GT results obtained during the 2 study periods are shown in Table 1. While very low frequencies (<0.1%) of invalid results due to internal control amplification failures were observed, there were relatively high frequencies of an “HCV not detected” result, at 14.4% and 16.4% of all test results during periods 1 and 2, respectively. Despite a requested minimum HCV VL of 500 IU/mL, VL data were not available for confirmation among the majority of specimens (>99.0%) prior to testing by HCVGT II during either period. Implementation of a strict minimum HCV VL requirement (ie, 500 IU/mL) for all specimens submitted for HCVGT II testing may have reduced the relatively high frequency of “HCV not detected” results observed during both periods. During Ropivacaine HCl 2, supplemental testing with HCVGT Plus was performed on 1,600 of 25,361 (6.3%) specimens (Table 2). Overall, resolution testing with HCVGT Plus during period 2 significantly reduced the frequency of ambiguous GT results (ie, “HCV Detected”, GT 1, and GT 1 with another GT) when compared to results from HCVGT II during period 1 (6.4% versus 1.1%; p <0.01) and results of initial HCVGT II testing during period 2 (6.3% versus 1.1%; p <0.01). Despite a modest reduction in the frequency of an “HCV detected” result without a definitive GT assignment following resolution testing with HCVGT Plus during period 2, the frequencies of an “HCV detected” result were not significantly different for the 2 periods (0.8% versus 0.7%; p = 0.3095), suggesting that low HCV VL (ie, <500 IU/mL) may have been a primary reason for failure to assign a definitive HCV GT during both periods. However, use of HCVGT Plus during period 2 did significantly reduce the frequency of a GT 1 without ST assignment (0.4%) as compared to corresponding frequencies observed with HCVGT II testing during period 1 (5.5%; p <0.01) and initial HCVGT II testing during period 2 (5.3%; p <0.01). Additionally, 38 of 25,361 (0.1%) specimens generating initial HCVGT II results of “HCV detected” (n = 17) and GT 1 (n = 21) generated a GT 6 result following resolution testing with HCVGT Plus.
    Discussion The present study compared HCV GT results from a large cohort of clinical specimens tested with HCVGT II alone and in combination with HCVGT Plus during 2 consecutive periods. When performed in conjunction with HCVGT II for resolution of ambiguous GT results, HCVGT Plus proved to be efficient and easily adaptable to routine clinical laboratory use, given the ease of result interpretation and use of a shared instrument platform (Abbott m2000 RealTime PCR System) with a highly automated workflow and high specimen throughput. While use of Sanger or next-generation sequencing may be suitable alternatives for HCVGT II resolution testing, these methods also have disadvantages and/or limitations, including high costs and complexity, limited throughput, and the potential for sequencing failure [6,8,10,11]. Despite several HCVGT Plus design limitations, including its limited GT coverage (ie, 1a, 1b, and 6) and inability to detect and/or correctly identify all strains of GT 6 [8,10], the assay complements HCVGT II well and thus helps to overcome some of the well-documented shortcomings of the HCVGT II assay design [[6], [7], [8], [9],[11], [12], [13]]. However, simultaneous testing of all specimens with both assays would not be cost-effective, given the relatively low percentage (6.3%) of specimens requiring resolution testing with HCVGT Plus and the additional reagent and labor costs. When compared to use of HCVGT II alone, resolution testing with HCVGT Plus significantly reduced the frequency of GT 1 without ST results, while also providing the ability to identify GT 6, among clinical specimens tested at a large reference laboratory.