HIV Point of Care Diagnostics Pipeline

By Polly Clayden

From Treatment Action Group and HIV i-Base

September 2011

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Table 1: CD4 Point of Care Test Pipeline
Test	Turnaround Time/Capacity	Sample Needed	Cost Test/Instrument*	Power	Environment	Training (Layperson)
Zyomyx CD4 counter	10 minutes 40 samples per day	100 uL finger stick blood	$6-7 $100	None	TBD	Less than 30 minutes
Burnet Institute CD4 counter	20 minutes 8-10 tests per hour (running cartridges in parallel)	10 μL finger stick blood; can also use venous blood	TBD	Battery	TBD	Less than 120 minutes
DaktariTM CD4 Counter	8 minutes 40-50 samples per day	20 μL finger stick blood applied to cartridge	$8 $800	AC, on board long life rechargeable battery	Temperature 4O to 370	Less than 90 minutes
MBio CD4 system	20 minutes 8-10 tests per hour	10 μL finger stick blood; can also use venous blood	TBD	Battery	TBD	Less than 90 minutes
* Estimated cost.

Viral Load

The SAMBA (simple amplification based assay), is currently being developed by the Diagnostics Development Unit at the University of Cambridge.⁷

They are developing two tests, a semi quantative test for monitoring ART and a qualitative test for EID. The tests use isothermal amplification and visual detection by dipstick. SAMBA is being field tested by MSF in Malawi.⁸

The Liat TM Analyser, manufactured by IQuum, POC HIV assay is a real time, battery operated, small, portable, PCR kit. Blood is collected in a tube and inserted into the analyzer. Results are quantitative.

Clinical trials are scheduled for 2011 with the potential for launch in 2012.⁹

Alere NAT system is a generic platform designed to detect various nucleic acids. The first test -- anticipated to be commercially launched next year -- is a real time detection method for measuring quantative HIV RNA. The sample -- which can be from finger-stick, whole blood, or plasma -- is applied directly onto the disposable cartridge, which is processed by a compact, battery driven instrument.¹⁰

Table 2: Viral Load Point of Care Test Pipeline
Test	Turnaround Time/Capacity	Sample Needed	Cost Test/Instrument*	Power	Environment	Training (Layperson)
SAMBA	60 minutes 4 samples per run	200mL plasma or 100 μL blood	TBD $2500 to $5000	AC or battery	N/A	Minimal
LiatTM Analyser	30 to 55 minutes 8 to 15 samples per day (depending on limit of detection)	200mL plasma or 10-50 μL of finger stick blood	TBD	AC or battery	Operating Temperature 15° to 30° C (59° to 86° F)	One hour
Alere	0 to 60 minutes	25 μL finger stick	TBD	On board rechargeable battery	Operating Temperature: 15° to 40° C (59° to 104° F) Humidity: <90% relative humidity Maximum altitude: N/A (permissible atmospheric pressure: 850 to 1100 hPa)	Less than 90 minutes
* Estimated cost.

Early Infant Diagnosis

Virological testing or ultrasensitive p24 antigen testing should be used for EID. It is possible to use qualitative HIV RNA assays, as described above, as an alternative to HIV DNA. The SAMBA system is developing a test especially for this purpose.

North Western Global Health Foundation (NWGHF) is developing an HIV DNA-PCR test which is on hold -- is not yet ready for field-testing -- while the group focuses on a POC p24 test.¹¹

Both Micronics and BioHelix have DNA tests which appear to be in the proof of concept stage and are not ready for field-testing yet either.

The NWGHF p24 antigen rapid test consists of a plasma separator, reaction tube, reaction buffer, and rapid test strip. It is small, battery operated, and expected to be inexpensive. It has demonstrated about 95% sensitivity and 99% specificity.¹²

Clinical and field trials are expected to start this year and it should be available in 2012.

Table 3: p24 Test for EID Pipeline
Test	Turnaround Time/Capacity	Sample Needed	Cost Test/Instrument*	Power	Environment	Training (Layperson)
NWGF p24 lateral flow assay	30 minutes 16 samples per day	75mL heel stick blood	$10 $150	Battery	TBD	Minimal
* Estimated cost.

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This article was provided by Treatment Action Group and HIV i-Base. It is a part of the publication 2011 Pipeline Report.

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