Comparison of Two Commercial Immunoassays for the Detection of Anti‐Rubella IgM and IgG in Pediatric Patients

Oliveira, Laura Cardellini Barbosa de; Okay, Thelma Suely; Kawasato, Karina Hatamoto; Lima, Loyze Paola Oliveira de

doi:10.1080/15321810701454953

Cited by 2 publications

(1 citation statement)

References 18 publications

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“…7 For these reasons the evaluation of the serological status of childbearing age women is strongly recommended and the analytical performances of currently available tests needs to be evaluated. 3,16,18,20 The current testing policies in Italy is to test for both specific IgM and IgG. [6][7][8] There is still no consensus on the follow-up testing on IgM and IgG positive cases.…”

Section: Discussionmentioning

confidence: 99%

Multicentric evaluation of two chemiluminescent immunoassays for IgG and IgM antibodies towards Rubella virus

Portella

Galli²

2010

Journal of Clinical Virology

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Section: Discussionmentioning

confidence: 99%

Multicentric evaluation of two chemiluminescent immunoassays for IgG and IgM antibodies towards Rubella virus

Portella

Galli²

2010

Journal of Clinical Virology

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Results of Continuous Monitoring of the Performance of Rubella Virus IgG and Hepatitis B Virus Surface Antibody Assays Using Trueness Controls in a Multicenter Trial

Kruk

Ratnam

Preiksaitis

et al. 2012

Clin. Vaccine Immunol.

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We conducted a multicenter trial in Canada to assess the value of using trueness controls (TC) for rubella virus IgG and hepatitis B virus surface antibody (anti-HBs) serology to determine test performance across laboratories over time. TC were obtained from a single source with known international units. Seven laboratories using different test systems and kit lots included the TC in routine assay runs of the analytes. TC measurements of 1,095 rubella virus IgG and 1,195 anti-HBs runs were plotted on Levey-Jennings control charts for individual laboratories and analyzed using a multirule quality control (MQC) scheme as well as a single three-standard-deviation (3-SD) rule. All rubella virus IgG TC results were "in control" in only one of the seven laboratories. Among the rest, "out-of-control" results ranged from 5.6% to 10% with an outlier at 20.3% by MQC and from 1.1% to 5.6% with an outlier at 13.4% by the 3-SD rule. All anti-HBs TC results were "in control" in only two laboratories. Among the rest, "out-of-control" results ranged from 3.3% to 7.9% with an outlier at 19.8% by MQC and from 0% to 3.3% with an outlier at 10.5% by the 3-SD rule. In conclusion, through the continuous monitoring of assay performance using TC and quality control rules, our trial detected significant intra-and interlaboratory, test system, and kit lot variations for both analytes. In most cases the assay rejections could be attributable to the laboratories rather than to kit lots. This has implications for routine diagnostic screening and clinical practice guidelines and underscores the value of using an approach as described above for continuous quality improvement in result reporting and harmonization for these analytes. In clinical laboratories many different factors, such as test systems employing a variety of different measurement procedures, lot variations of test kits, equipment calibration, and malfunction and other technical and human errors can lead to shifts in the mean test values and affect the assay result and interpretation. Most laboratories subscribe to external proficiency testing programs to ascertain whether their testing method still works and can produce the specified result. While this allows for validating the performance of assays during specific time intervals, thus providing a snapshot of the quality of the assay, variations due to random and systematic errors caused by a variety of factors over time cannot be detected by proficiency testing, whereas continuous monitoring of assays using trueness controls (TC) in conjunction with control charts and the multirule quality control (MQC) scheme as proposed by Westgard et al. (16) can alert workers to changes in assay performance in real time. Such an approach will ensure that corrective measures are taken immediately and errors do not proliferate. This is essential in maintaining quality assurance for diagnostic assays and the reproducibility of test results.International public health guidelines for rubella virus and hepatitis B virus serology have stated tha...

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Comparison of Two Commercial Immunoassays for the Detection of Anti‐Rubella IgM and IgG in Pediatric Patients

Cited by 2 publications

References 18 publications

Multicentric evaluation of two chemiluminescent immunoassays for IgG and IgM antibodies towards Rubella virus

Multicentric evaluation of two chemiluminescent immunoassays for IgG and IgM antibodies towards Rubella virus

Results of Continuous Monitoring of the Performance of Rubella Virus IgG and Hepatitis B Virus Surface Antibody Assays Using Trueness Controls in a Multicenter Trial

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