Table 4 Specifications of recently-entered market* technologies for malaria diagnosis.

Microscopy

Parasight

Sight Diagnostics Ltd, 2014

Automated microscopy suitable for processing of multiple malaria

Slide reading

Under way

n/a

Blood smear

n/a

n/a

n/a

n/a

Malaria RDTs**

Fio-net

Fio Corporation, 2012

Universal RDT reader and cloud information services to improve malaria RDT quality assurance and malaria surveillance

Combination of mobile diagnostics (mobile universal reader) with cloud information services

Automated and customising reports

Sensitivity and specificity are functions of the RDTs being read

RDTs processing time is dependent on manufacturer’s recommendation

Data upload within minutes

Daily quality control needed

Depending on RDTs’ manufacturers

Subject to RDTs manufacturers’ recommendations

5–40 °C

Similar to pre-paid cellphone plans

Battery powered

Basic 1 day training needed

On screen and web portal

CE marked

UMT

Fyodor Biotechnologies, 2015

A senstitive and specific lateral flow assay detecting novel Plasmodium proteins shed in the urine of febril malaria patients

Dipstick technology (lateral flow assay)

LOD 125 parasites/µL

~ 20 min

100 µL urine

n/a

n/a

Usable by lay people

n/a

n/a

Holomic Rapid Diagnostic Reader

Holomic LLC, 2013

Universal RDT reader attachment for smartphones and software to read RDTs and transmit result to a secure cloud information service

Portable, smartphone-based lateral flow immunoassay reader

Quantitative and qualitative

RDTs processing time is dependent on manufacturer’s recommendation

Data upload within seconds

Depending on RDTs’ manufacturers

Subject to RDTs manufacturers’

5–40 °C

Customisable

$US500

Battery powered

Basic < 0.5 day training needed

User interface of the smartphones application

Class I medical device

Nucleic acid detection

LAMP Malaria Diagnostic Kit

Eiken Chemical Ltd and FIND, 2012

Commercial LAMP test kit containing primers and reagents needed to run assays using benchtop laboratory equipment

Isothermal DNA amplification

Fluorescence of visual detection

For pan-LAMP: 97.0% sensitivity

For Pf-LAMP: 93.3% sensitivity

85.0% specificity

60 min

30–60 µL blood

Stable for 12 months at < 30 °C

$US5

$US10’000

Electricity (batter-powered possible)

4 days of training required

Turbidimeter and software

CE marked

Positive and negative controls included

illumigene LAMP

Meridian Bioscience

An automated and compact LAMP technology to qualitatively detect Plasmodium spp. DNA in human whole blood samples

Isothermal DNA amplification

Sensitivity 100%

Specificity 89.3%

< 50 min

Human whole blood

Stable for 12 months at 2–30 °C

n/a

Does not require specialised laboratory equipment

n/a

CE marked

MicroPCR

Tulip Group and Bigtec Labs, 2013

POC real-time quantitative PCR instrument

Fluorescent probe-based real-time PCR

> 99% sensitivity and specificity

LOD 2 parasites/µL blood

45–60 min

100 µL blood

15–30 °C

$US15

$US8000

Battery powered

1–2 days training required

5000 test results can be stored internally, cloud information available

CE marked

Truelab

Molbio, 2013

A quantitative micro PCR platform containing all equipment and reagents needed for point-of-care applications

Using the proprietary magnetic nanoparticles to capture DNA

n/a

< 60 min

Whole blood

n/a

n/a

A customised micro printer is available

n/a