Lr. Krilov et al., EVALUATION OF A RAPID DIAGNOSTIC-TEST FOR RESPIRATORY SYNCYTIAL VIRUS(RSV) - POTENTIAL FOR BEDSIDE DIAGNOSIS, Pediatrics, 93(6), 1994, pp. 903-906
Objective. Rapid detection of respiratory syncytial virus (RSV) infect
ion can assist clinicians in decisions regarding antiviral therapy wit
h ribavirin as well as instituting infection control measures. The Abb
ott TestPack RSV is a rapid RSV detection immunoassay that can be perf
ormed on respiratory secretions in 20 to 30 minutes without special la
boratory equipment. The purpose of this study was to evaluate housesta
ff performance of the TestPack RSV at bedside as compared with laborat
ory testing of aliquots of the same specimen by tissue culture inocula
tion, direct fluorescent antibody (DFA) testing, and TestPack RSV. Met
hods. During the 1991 through 1992 RSV season, 137 nasopharyngeal aspi
rates or washes obtained from pediatric patients <4 years of age suffe
ring from acute respiratory disease were assayed by the Food and Drug
Administration-approved TestPack RSV as well as conventional tube cult
ure and DFA testing. Results. 66 of 137 (48%) specimens were positive
for RSV as defined by: isolation and DFA-positive (n = 48) and DFA tes
ting positive with negative culture (n = 18); blocking assay experimen
ts using TestPack RSV confirmed culture-negative DFA-positive specimen
s as positive in 8/8 instances in which material for retesting was ava
ilable. Using these definitions, the sensitivity and specificity for t
he assays were: housestaff TestPack RSV: 92%, 93%; laboratory TestPack
RSV: 97%, 98%; virus isolation: 72%, 100%. Conclusion. From these dat
a, it appears that the TestPack RSV EIA in the field setting is reliab
le, although laboratory confirmation of results is important.