ASSURED criteria (WHO) for the evaluation of point-of-care devices

Characteristic Example target specification

AffordableLess than US$ 500 per machine, less

than US$ 10 per test

Sensitivity, Specificity

Lower limit of detection: 500 HIV RNA copies per mL, 350 CD4+ T-cells per

μL

User-friendly 1–2 days of training, easy to use

Rapid and robust

< 30 minutes for diagnosis, < 1.5 hours for HIV load monitoring, minimal consumables (i.e. pipettes),

shelf life > 1 year at room temperature, high throughput

Equipment-freeCompact, battery powered, on-site data analysis, easy disposal, easy

sample handling, no cold chain

Deliverable Portable, hand-heldhttp://www.who.int/bulletin/volumes/90/12/BLT-12-102780-table-T1.html

http://www.finddiagnostics.org/

http://developeconomies.com/

http://www.popularmechanics.com

http://jaffeweb.ucsd.edu/node/81 http://www.finddiagnostics.org/

http://www.forbes.com/sites/gcaptain/2011/10/04/the-ocean-network

The LAMP reactionFeatures:

Isothermal (60-65 °C)

No heat denature required

High gain: ~109

PCR-like sensitivity, selectivity

Robustness to many PCR inhibitors

‘One-pot’ DNA or RNA

Tomita, et al. “Loop-mediated isothermal amplification (LAMP) of gene sequences and simple visual detection of products”, Nature Protocols, Vol. 3 No. 5, pg. 877, 2008.

c

- + + +

t=0, room temperature

t=1 h, reaction (65 oC )

+

- + + ++

1 2 3 4 5 6 7 80.5

0.75

1

1.25

1.5

1.75

2

LAMPASU

Template copies per 10 ml(log10)

Ct(h

ours

)

~20

Background of 100 ng/µl Salmon sperm DNA