Single-use, electricity-free amplification device for detection of HIV-1.
Early and accurate diagnosis of HIV is key for the reduction of transmission and initiation of patient care. The availability of a rapid nucleic acid test (NAT) for use at the point-of-care (POC) will fill a gap in HIV diagnostics, improving the diagnosis of acute infection and HIV in infants born to infected mothers. In this study, we evaluated the performance of non-instrumented nucleic acid amplification, single-use disposable (NINA-SUD) devices for the detection of HIV-1 in whole blood using reverse-transcription, loop-mediated isothermal amplification (RT-LAMP) with lyophilized reagents. The NINA-SUD heating device harnesses the heat from an exothermic chemical reaction initiated by the addition of saline to magnesium iron powder. Reproducibility was demonstrated between NINA-SUD units and comparable, if not superior, performance for detecting clinical specimens was observed as compared to the thermal cycler. The stability of the lyophilized HIV-1 RT-LAMP reagents was also demonstrated following storage at -20, 4, 25, and 30°C for up to one month. The single-use, disposable NAT minimizes hands-on time and has the potential to facilitate HIV-1 testing in resource-limited settings or at the POC.
Laboratory Branch, Division of HIV/AIDS Prevention, National Center for HIV/AIDS, Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, 1600 Clifton Road NE, Atlanta, GA 30329, USA. Electronic address: czv2@cdc.gov.
Kelly A
KA
Curtis
Laboratory Branch, Division of HIV/AIDS Prevention, National Center for HIV/AIDS, Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, 1600 Clifton Road NE, Atlanta, GA 30329, USA.
Donna L
DL
Rudolph
Laboratory Branch, Division of HIV/AIDS Prevention, National Center for HIV/AIDS, Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, 1600 Clifton Road NE, Atlanta, GA 30329, USA.
Daphne
D
Morrison
PATH, 2201 Westlake Avenue, Suite 200, Seattle, WA 98121, USA.
Dylan
D
Guelig
PATH, 2201 Westlake Avenue, Suite 200, Seattle, WA 98121, USA.
Steven
S
Diesburg
PATH, 2201 Westlake Avenue, Suite 200, Seattle, WA 98121, USA.
David
D
McAdams
PATH, 2201 Westlake Avenue, Suite 200, Seattle, WA 98121, USA.
Robert A
RA
Burton
PATH, 2201 Westlake Avenue, Suite 200, Seattle, WA 98121, USA.
Paul
P
LaBarre
Laboratory Branch, Division of HIV/AIDS Prevention, National Center for HIV/AIDS, Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, 1600 Clifton Road NE, Atlanta, GA 30329, USA.
Michele
M
Owen
D004560:Electricity; D015658:HIV Infections / Q000097:blood / Q000175:diagnosis* / Q000821:virology; D015497:HIV-1 / Q000235:genetics* / Q000302:isolation & purification*; D006358:Hot Temperature; D006801:Humans; D021141:Nucleic Acid Amplification Techniques / Q000295:instrumentation / Q000379:methods; D019095:Point-of-Care Systems; D012367:RNA, Viral / Q000235:genetics / Q000302:isolation & purification; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity
D012367:RNA, Viral
Diagnosis; HIV-1; Nucleic acid amplification; Point-of-care; RNA