PMID- 11587348
OWN - NLM
STAT- MEDLINE
DCOM- 20020228
LR  - 20191210
IS  - 1387-2273 (Print)
IS  - 1387-2273 (Linking)
VI  - 761
IP  - 2
DP  - 2001 Sep 25
TI  - Validation of a high-performance liquid chromatographic assay for the 
      quantification of adenovirus type 5 particles.
PG  - 187-94
AB  - An anion-exchange-high-performance liquid chromatography (AE-HPLC) method for the 
      quantification of adenovirus type 5 (Ad5) total particles was validated according 
      to performance criteria of precision, specificity, linearity of calibration and 
      range, limit of detection, limit of quantification, accuracy and recovery. The 
      viral particles were detected by absorbance at 260 nm using photodiode array 
      detector (PDA). Cesium chloride (CsCl) purified Ad5 and lysate samples were used 
      for the validation of the method. Relative standard deviations (RSDs) for the 
      inter-day, intra-day precision and reproducibility for both the lysate and the 
      Ad5 standard were less than 10 and 2% for the peak area and retention time, 
      respectively. The method was specific for Ad5 which was eluted at 8.0 min. The 
      presence of DNA does not affect the recovery of Ad5 particles for accurate 
      quantification. Based on the error in prediction to be less than 10%, the working 
      range was established between 2 x 10(10) and 7 x 10(10) VP/ml with correlation 
      coefficient of 0.99975, standard deviation of 6.14 x 10(9) VP/ml and a slope of 
      3.04 x 10(5) VP/ml. The recovery of the method varied between 88 and 106% in all 
      of the lysate samples investigated which is statistically similar to 100% 
      recovery at 95% confidence interval.
FAU - Transfiguracion, J
AU  - Transfiguracion J
AD  - Animal Cell Technology and Downstream Processing Group, Biotechnology Research 
      Institute, National Research Council of Canada, Montreal, Quebec.
FAU - Bernier, A
AU  - Bernier A
FAU - Arcand, N
AU  - Arcand N
FAU - Chahal, P
AU  - Chahal P
FAU - Kamen, A
AU  - Kamen A
LA  - eng
PT  - Journal Article
PT  - Validation Study
PL  - Netherlands
TA  - J Chromatogr B Biomed Sci Appl
JT  - Journal of chromatography. B, Biomedical sciences and applications
JID - 9714109
RN  - 0 (Anion Exchange Resins)
SB  - IM
MH  - Adenoviridae/*isolation & purification
MH  - Anion Exchange Resins
MH  - Chromatography, High Pressure Liquid/*methods
MH  - Chromatography, Ion Exchange/*methods
MH  - Humans
MH  - Reproducibility of Results
MH  - Sensitivity and Specificity
MH  - Viremia/*blood
MH  - Virion/*isolation & purification
EDAT- 2001/10/06 10:00
MHDA- 2002/03/01 10:01
CRDT- 2001/10/06 10:00
PHST- 2001/10/06 10:00 [pubmed]
PHST- 2002/03/01 10:01 [medline]
PHST- 2001/10/06 10:00 [entrez]
AID - 10.1016/s0378-4347(01)00330-9 [doi]
PST - ppublish
SO  - J Chromatogr B Biomed Sci Appl. 2001 Sep 25;761(2):187-94. doi: 
      10.1016/s0378-4347(01)00330-9.