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Published on: December 3, 2011
Analytical and Clinical Evaluation of the AltoStar Adenovirus PCR Kit 1.5 and the AltoStar Automation System AM16 for
Krupa Jani1, Taheefa Stephen1, Cindy Lee1
1Clinical Microbiology Service, Department of Pathology and Laboratory Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.
Abstract:
Human adenoviruses (HAdVs) can result in significant morbidity and mortality in immunocompromised patients. The AltoStar Adenovirus PCR Kit 1.5 (AltoStar HAdV PCR) is a real-time PCR test for the detection and quantification of HAdV DNA. In this study, the performance of the AltoStar HAdV PCR was evaluated compared with a laboratory-developed HAdV PCR based on MultiCode HAdV reagents (MultiCode HAdV PCR) using plasma and stool specimens. Performance of the AltoStar HAdV PCR was established by determining the linearity, lower limit of detection, precision, specificity, accuracy, and inclusivity of the assay. Accuracy was determined by testing plasma and stool clinical samples previously tested by the MultiCode HAdV PCR and inclusivity evaluated by using several HAdV genotypes. A time-and-motion study was performed to compare the workflows of both PCRs. The limit of detection was <200 copies/mL for both sample types. Overall agreement with the MultiCode HAdV PCR was 91% for plasma samples and 85.5% for stool samples. Quantitative agreement between the two tests was moderate. Specificity and precision in both sample types were high. All major HAdV species tested were detected. Hands-on-time was significantly less for the semi-automated AltoStar HAdV PCR. The AltoStar HAdV PCR showed great performance for the detection and/or quantitation of HAdV in clinical samples.
Insights
The AltoStar Human Adenovirus (HAdV) PCR Kit 1.5 accurately detects HAdV DNA in patient samples. This real-time PCR test offers high specificity and precision, with reduced hands-on time compared to other methods.
Area of Science:
- Clinical Virology
- Molecular Diagnostics
Background:
- Human adenoviruses (HAdV) pose significant health risks, particularly to immunocompromised individuals.
- Accurate and efficient detection of HAdV is crucial for patient management.
Purpose of the Study:
- To evaluate the performance of the AltoStar HAdV PCR Kit 1.5 for detecting and quantifying HAdV DNA.
- To compare the AltoStar HAdV PCR with a laboratory-developed MultiCode HAdV PCR assay.
Main Methods:
- Assessed linearity, limit of detection (LOD), precision, specificity, accuracy, and inclusivity.
- Tested plasma and stool clinical samples against the MultiCode HAdV PCR.
- Conducted a time-and-motion study to compare workflow efficiency.
Main Results:
- The AltoStar HAdV PCR demonstrated an LOD below 200 copies/mL for both sample types.
- Achieved 91% agreement for plasma and 85.5% for stool samples compared to the MultiCode HAdV PCR.
- Exhibited high specificity and precision, detecting all major HAdV species tested, with significantly less hands-on time.
Conclusions:
- The AltoStar HAdV PCR Kit 1.5 is a high-performing assay for HAdV detection and quantification in clinical specimens.
- Its efficiency and accuracy make it a valuable tool in clinical virology settings.
