South Africa and 38 other countries with high-burdens of tuberculosis (TB) will benefit from a pricing agreement that will see the introduction of a test that is set to initiate a dramatic decrease in the time it takes to test for TB and multi-drug resistant (MDR) TB.

South Africa will benefit from the pricing agreement as the MGIT machine is already being used by the country’€™s National Health Laboratory Services (NHLS). However, countries such as Kenya, Zambia, Brazil and Russia, that also have high burdens of TB, will be able to introduce the MGIT machine more widely.

A test for multi-drug resistant (MDR) TB and drug susceptibility testing, both critical to determine the treatment for a patient, will cost U$3, half of what it cost before the agreement.

Laboratory diagnosis of TB largely relies on the direct microscopic examination of sputum specimens. However, the technique developed when TB was discovered is known to have low and variable sensitivity and cannot identify drug-resistant strains.

The next step, which involves mycobacterial culture in a laboratory, is more sensitive, but growth of the TB bacteria on traditional ‘€œsolid media’€ typically requires two to four weeks and as many as eight weeks of incubation.

This leads to delays before patients are placed on the appropriate treatment and often patients die while waiting or infect their families and friends.

The MGIT system that will now be made available more widely uses a ‘€œliquid culture’€ that reduces the delays in obtaining results by one to two weeks over the traditional solid media.

For drug sensitivity testing the interval may be reduced to as little as 10 days, compared with 28 to 42 days with conventional solid media.

Liquid systems are also more sensitive for detection of mycobacteria.

Becton, Dickinson and Company (BD), a global medical technology company, and FIND (Foundation for Innovative New Diagnostics), a non-profit product development partnership, announced the pricing agreement in the week of the 38th Union World Conference on Lung Health being held in Cape Town.

The FIND/BD negotiated price for the public health sector in these countries is significantly lower than prices commonly paid in industrialized countries.

The pricing agreement comes after recommendations by the World Health Organisation (WHO) for the use of mycobacterial liquid culture and drug susceptibility testing in low and middle-income countries.

Krista Thompson, Vice-president at BD said the agreement and recommendation by the WHO had come after a three year trial showing that the machines could be used at district hospital level. Many countries, where the burden is high, have no laboratory infrastructure and rely on microscopy of which the sensitivity to TB is as low as 30 percent.

The move by FIND/BD and the WHO is part of a strategy for addressing the emergence of extensively drug-resistant (XDR) TB.

Thompson said the company’€™s products had the potential to have a profound impact on the diagnosis and treatment of TB patients in the developing world, including those co-infected with HIV. The company was currently investigating improved diagnostics that could decrease the waiting time even further and could be even simpler to use at operational level, but for now the MGIT is the best option.

Neliswa Nkwali of the Treatment Action Campaign in Khayelitsha told a press briefing this week that there was a critical need for new diagnostics for suspected MDR TB patients.

‘€œOur people die while waiting for the labs,’€ she said.

Gerrit Coetzee of the NHLS said the case load was ‘€œenormous’€.

The Green Point laboratory, which does the testing for the whole of the Western Cape, does anything between 13 000 and 15 000 cultures a month.

Currently a suspected TB patient’€™s sputum is collected at a clinic or hospital and diagnosed using microscopes at the clinic or hospital. The sensitivity of this test is as low as 30%.

If they fail to identify TB, a sample is sent to the laboratory in Green Point where the TB organism is cultured. The laboratory is then able to identify MDR TB and do drug susceptibility testing to determine which drugs the patient is resistant to. MDR and XDR TB cannot be identified without a culture and this can only be done at the Green Point laboratory. There are 15 such laboratories in the country and none in many African countries.

FIND is a non-profit organization which aims to support and promote the health of those living in developing countries by sponsoring, developing and introducing new, but affordable diagnostic tools for poverty related diseases. ‘€“ Health-e News Se