Evaluation of the NanoChip 400 System for Detection of Influenza A and B, Respiratory Syncytial, and Parainfluenza Viruses

Abstract

The NanoChip400 system uses multiplex PCR chemistry and electronic microarray detection of influenza A and B viruses; respiratory syncytial viruses A and B; and human parainfluenza virus types 1, 2, and 3. The results obtained with the NanoChip 400 system were compared with those obtained by direct fluorescent-antibody staining (DFA) and real-time PCR with 122 and 130 specimens, respectively. Concordance between DFA and NanoChip 400 system was obtained for 106 of 122 (86.9%) specimens. On the basis of discrepancy analysis with specimens available for confirmatory real-time PCR testing, the sensitivity and specificity of the NanoChip 400 were 98.6% and 100%, respectively. With respect to specimens previously tested by real-time PCR, the NanoChip 400 system demonstrated a sensitivity of 91.1% and a specificity of 100%. The NanoChip 400 system provides clinical laboratories with a practical, rapid, and sensitive method for the detection of common respiratory viruses.There has been a considerable effort over the past two decades or more to develop methods for the rapid detection of viral agents. Although enzyme immunoassay and lateral flowbased antigen detection are the most frequently used methods for the rapid detection of respiratory viruses, the most reliable antigen detection method for respiratory viruses is considered to be direct fluorescent-antibody staining (DFA), based on extensive studies conducted over the past 20 years (4, 9). While DFA has generally shown good performance in comparison to viral culture, the actual sensitivity is probably lower than that in published reports of studies that used viral culture as the "gold standard," given the lability of respiratory viruses.While viral culture is considered the gold standard, specimen handling is a major factor in the recovery of respiratory viruses; furthermore, even with shell vial cultures, the clinical utility of viral culture has limitations, as the results do not have an immediate effect on clinical as well as infection control decisions (11).Screening for multiple viral agents by DFA is extremely useful for patient management as well as infection control. While the cost-effectiveness and cost-benefit of a rapid antigen detection infection control program for the reduction of nosocomial respiratory virus transmission have been demonstrated (1, 6, 13), the lack of trained personnel on off-shifts often limits the use of DFA to a single shift in many health care settings. While real-time PCR methods are available as analyte-specific reagents, real-time PCR is limited to the simultaneous detection of three respiratory viruses.DFA requires highly trained clinical laboratory scientists and is subject to nonspecific staining with specimens containing yeasts, certain bacteria, leukocytes, or mucus as well as because of binding to FC receptors (7,8,12). The specimen type and the collection technique are also important factors. Furthermore, it has been reported that approximately 5% of respiratory specimens submitted for immunofluorescence examination are ...

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