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.jpg): Failed to open stream: No such file or directory in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 117 J+Clin+Microbiol
2017 ; 55
(5
): 1576-1584
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Evaluation of Altona Diagnostics RealStar Zika Virus Reverse Transcription-PCR
Test Kit for Zika Virus PCR Testing
#MMPMID28298448
L'Huillier AG
; Lombos E
; Tang E
; Perusini S
; Eshaghi A
; Nagra S
; Frantz C
; Olsha R
; Kristjanson E
; Dimitrova K
; Safronetz D
; Drebot M
; Gubbay JB
J Clin Microbiol
2017[May]; 55
(5
): 1576-1584
PMID28298448
show ga
With the emerging Zika virus (ZIKV) epidemic, accessible real-time reverse
transcription-PCR (rRT-PCR) assays are needed to streamline testing. The
commercial Altona Diagnostics RealStar ZIKV rRT-PCR test kit (Altona PCR) has
been approved for emergency use authorization by the U.S. FDA. Our aim was to
verify the Altona PCR by comparing it to the CDC-designed dual-target ZIKV
rRT-PCR reference assay (reference PCR) and describe the demographics of patients
tested for ZIKV by rRT-PCR in Ontario, Canada. A large set of clinical specimens
was tested for ZIKV by the Altona PCR and the reference PCR. Positive or
equivocal specimens underwent PCR and Sanger sequencing targeting the ZIKV NS5
gene. A total of 671 serum specimens were tested by the reference PCR: 58 (8.6%)
were positive, 193 (28.8%) were equivocal, and 420 (62.6%) were negative. Ninety
percent of the reference PCR-positive patients were tested in the first 5 days
after symptom onset. The Altona PCR was performed on 284/671 specimens tested by
the reference PCR. The Altona PCR was positive for 53/58 (91%) reference
PCR-positive specimens and 16/193 (8%) reference PCR-equivocal specimens; the
ZIKV NS5 PCR was positive for all 68 Altona PCR-positive specimens and negative
for all 181 Altona PCR-negative specimens that underwent the NS5 PCR. The Altona
PCR has very good sensitivity (91%) and specificity (97%) compared to the
reference PCR. The Altona PCR can be used for ZIKV diagnostic testing and has
less extensive verification requirements than a laboratory-developed test.