PMID- 35104162
OWN - NLM
STAT- MEDLINE
DCOM- 20220419
LR  - 20220419
IS  - 1557-8976 (Electronic)
IS  - 0882-8245 (Linking)
VI  - 35
IP  - 2
DP  - 2022 Mar
TI  - Evaluation and Correlation of Rabies Vaccine Potency Using the National Institute 
      of Health, Rapid Focus Fluorescent Inhibition, and Passive Hemagglutination 
      Tests.
PG  - 159-169
LID - 10.1089/vim.2021.0181 [doi]
AB  - Rabies vaccine preparations are quantitatively assayed for potency using the 
      in-vivo challenge National Institute of Health (NIH), the main test that consumes 
      a high number of animals, takes a long time, and has wide variability. The Rapid 
      focus fluorescent inhibition (RFFIT) and the passive hemagglutination (PHA) 
      tests, the two serologically based tests, were also used for such purpose. In 
      this study, we aimed to evaluate and correlate the potency of the NIH, RFFIT, and 
      PHA tests according to the World Health Organization (WHO) validity criteria, 
      aiming to validate the use of RFFIT or PHA test as a substitute to the NIH test 
      for determining the potency of commercially available Rabies vaccine 
      preparations. The results showed that, the three tests can be successfully used; 
      however, a higher correlation between RFFIT and NIH than PHA and NIH was recorded 
      (Pearson correlation = 1). The potency of rabies vaccine preparations using NIH, 
      RFFIT, and PHA were 3.73, 3.51, and 4.50, respectively. NIH is the main test for 
      the determination of vaccine potency carried out by conducting 25 experiments and 
      consuming about 5,000 mice compared to 1,200 mice used with RFFIT and 1,000 mice 
      used with PHA test. Taken together, we concluded that (i) in some tested 
      preparations, both RFFIT and PHA tests gave comparable results, and they can be 
      used interchangeably; (ii) RFFIT could successfully replace NIH test, but not 
      PHA; (iii) RFFIT and PHA tests are faster, more accurate, more economic, and more 
      sensitive than NIH; nevertheless, PHA needs further investigations; and (iv) both 
      RFFIT and NIH tests complement and reinforce each other as they provide a 
      comprehensive picture of the product potency.
FAU - Khalil, Walaa M
AU  - Khalil WM
AD  - Central Administration of Control of Biologicals and Innovative Products and 
      Clinical Trials, Egyptian Drug Authority Dokki, Cairo, Egypt.
FAU - Aboshanab, Khaled M
AU  - Aboshanab KM
AUID- ORCID: 0000-0002-7608-850X
AD  - Department of Microbiology and Immunology, Faculty of Pharmacy, Ain Shams 
      University, Cairo, Egypt.
FAU - Aboulwafa, Mohammad M
AU  - Aboulwafa MM
AD  - Department of Microbiology and Immunology, Faculty of Pharmacy, Ain Shams 
      University, Cairo, Egypt.
AD  - Faculty of Pharmacy, King Salman International University, Ras-Sedr, Egypt.
LA  - eng
PT  - Journal Article
DEP - 20220201
PL  - United States
TA  - Viral Immunol
JT  - Viral immunology
JID - 8801552
RN  - 0 (Antibodies, Viral)
RN  - 0 (Rabies Vaccines)
SB  - IM
MH  - Animals
MH  - Antibodies, Viral
MH  - Hemagglutination Tests
MH  - Mice
MH  - Neutralization Tests/methods
MH  - *Rabies/prevention & control
MH  - *Rabies Vaccines
MH  - *Rabies virus
MH  - Vaccine Potency
OTO - NOTNLM
OT  - NIH
OT  - PHA
OT  - RFFIT
OT  - potency
OT  - rabies
EDAT- 2022/02/02 06:00
MHDA- 2022/04/20 06:00
CRDT- 2022/02/01 17:09
PHST- 2022/02/02 06:00 [pubmed]
PHST- 2022/04/20 06:00 [medline]
PHST- 2022/02/01 17:09 [entrez]
AID - 10.1089/vim.2021.0181 [doi]
PST - ppublish
SO  - Viral Immunol. 2022 Mar;35(2):159-169. doi: 10.1089/vim.2021.0181. Epub 2022 Feb 
      1.