Data from: Development and proof of concept evaluation for a low-resource compatible Chikungunya virus diagnostic

Chikungunya virus (CHIKV) is a positive sense RNA Alphavirus that
continues to pose major public health threats throughout the world. CHIKV
is primarily transmitted via the Aedes genus mosquito; however, it has
also exhibited transmission routes via blood transfusion and vertical
transmission (mother to child). With only one approved vaccine thus far
and no approved medicines, early detection is crucial in mitigating CHIKV
outbreaks. Here, we designed and evaluated a sensitive and specific CHIKV
diagnostic using reverse transcription-recombinase aided amplification
(RT-RAA) coupled lateral flow strip detection (LFD) targeting a highly
conserved region of the CHIKV E1 gene. Our results demonstrate that using
our simple sample preparation reagent (TNA-Cifer-E) can inactivate live
CHIKV in two minutes at room temperature, whilst also sustaining viable
viral RNA. Our specificity analysis demonstrates that the Iso-CHIKV-Dx
does not detect any closely related Alphaviruses nor any of the common
co-circulating Flaviviruses. Proof-of-concept evaluation using urine
spiked with CHIKV exhibited that in CHIKV-infected urine samples, this
Iso-CHIKV-Dx can detect as low as 570 copies/μL of CHIKV RNA in 30 minutes
under isothermal conditions. Contrary to conventional RT-qPCR, our
Iso-CHIKV-Dx does not require expensive machinery, advanced
instrumentation or extensively trained personnel. Further performance
comparisons also show that this Iso-CHIKV-Dx is four times faster than
conventional RNA isolation and RT-qPCR. As such, pre-clinical evaluation
demonstrates that this Iso-CHIKV-Dx has the potential to act as a robust,
point of care CHIKV diagnostic that could prove to be highly beneficial in
place of, or in the absence of RT-qPCR.