This continuing activity, a dedicated technologist in support of early infant diagnosis via PCR, relates to

MoHSS PMTC 7334, CDC lab infrastructure 7358, NIP lab infrastructure 7337.

The Namibia Institute of Pathology (NIP) is responsible at the national level for provision of all HIV-related

testing technologies for the public sector. During FY 2005, the diagnostic algorithm for using dried blood

spots (DBS) and PCR for pediatric diagnosis was developed and field-tested. During FY 2006 in

collaboration with the Ministry of Health and Social Services (MoHSS) PMTCT program, this method was

introduced for symptomatic infants and HIV-exposed infants at six weeks of age. Staff at the lab have been

trained in PCR, new equipment has been bought, specimens are being processed and the rollout of

decentralized training of health workers in the collection of DBS is ongoing. It is expected that 20,000 of

these diagnostic PCR tests will be performed in FY 2008 and a dedicated technologist is needed for the

laboratory to have sufficient capacity in response to demand. This person is being supported by the CDC

laboratory scientist assigned to the NIP.

In COP08, USG will continue to provide technical assistance to the national TB laboratory at the Namibia

Institute of Pathology. This activity relates to the HLAB International Laboratory Branch Consortium

Partners activity (16241), HVTB TBCAP (16210) and the HLAB Comforce activity (16117). In COP06, a

comprehensive review of the TB laboratory program was performed including laboratory aspects of the

National TB Control Program (NTCP), the laboratories performing TB smear microscopy and culture, and

the needs of the NIP for developing a quality assurance program, followed by recommendations towards

capacity building and strengthening the national TB laboratory system. Based on the recommendations

from the assessment, a team of consultants from the American Society for Microbiology spent 2 months at

the NIP TB laboratory consulting on smear-microscopy training, use of liquid media for culture, rapid

identification of TB using DNA probes, and optimizing drug susceptibility testing. This support resulted in

increased capacity for accurate testing of patient specimens and for performing the National TB Control

Program (NTCP) Surveillance Study to determine resistance to anti-tuberculosis drugs in Namibia. This

survey will provide the NTCP with information on the burden of drug-resistant TB and its relationship with

HIV infection in the country. Information from this survey will be analyzed by NTCP and TBCAP to put in

place strategies to counter the problem. Furthermore, this information will justify the use of second line

drugs by NTCP and support the country's application to the Green Light committee for access to cheaper

second line drugs. The MGIT 960 instrument has been purchased and installed in the laboratory to replace

the BACTEC 460 radiometric system, and augment the lower-capacity BactAlert instruments. In COP07, 2

consultants from the American Society of Microbiology spent 3 months in the TB Lab assisting with

culture/DST and quality assurance to get the Lab ready for the MDR survey. In addition, one of the primary

concerns during the laboratory assessment was bio-safety; funds will be allocated to bio-safety training and

waste management in COP08. Namibia has one of the highest rates of tuberculosis in the world and TB

currently is the leading cause of death for persons with HIV. In addition to multi-drug resistant TB, Namibia

is facing the added challenge of identifying and responding to the potential emergence of extremely drug

resistant TB, first recognized in neighboring South Africa. This activity has four components: (1) Strengthen

the Namibia Institute of Pathology tuberculosis laboratories. This component will improve NIP's ability and

capacity to process a greater volume of testing anticipated from expanded testing for ART clinic patients

and other persons identified as being at risk of HIV and/or TB. (2) Introduction of Fluorescence Microscopy

at high TB burden Laboratories and Rapid TB diagnosis techniques at the reference Laboratory. With the

increasing TB diagnosis demand, there is a need to introduce fluorescence microscopy at some of the high

burden sites. This will make the diagnosis more sensitive and shorten the turn around time. It is also

important to introduce or evaluate new rapid TB diagnosis techniques to complement the routine

culture/DST. (3) Funding is also needed to upgrade the NIP LIS (Laboratory Information System) to be able

to produce reports for the NTCP, this has been found to be a weakness during COP07 technical review. (4)

Continue to support salaries of 2 medical technologists one of whom will be dedicated to quality assurance

of basic smear microscopy and 5 Laboratory assistants.

This is a continuing activity that contains four components which serve as the foundation for the quality

assurance provided at the national level to all rapid HIV testing sites in Namibia, including both public and

NGO/FBO sectors, the bioclinical monitoring of patients on HAART. This activity supports rapid and

extensive expansion of provider-initiated testing as well as existing VCT services Namibia Institute of

Pathology (NIP) is responsible at the national level for provision of all HIV-related testing technologies for

the public sector. With respect to rapid HIV testing, the NIP is responsible for validation of any new rapid

test technologies before being used in Namibia; making recommendations to the Ministry on the rapid

testing algorithm and selection of test kits; training and post-training certification (based on their first 50

samples being also tested by ELISA) of all rapid testers before they can give results; site inspection of all

new rapid test sites to ensure that they meet the minimum standards; preparation, distribution, and follow-

up analysis of quality controls and proficiency panels that are sent to rapid test sites; analysis of tested

samples from rapid test sites that is also tested by ELISA and following up any performance issues with the

tester; submission of reports on rapid test QA to the CT unit, Directorate of Special Programs, MoHSS.

Rapid HIV testing is still relatively new in Namibia, but has been spearheaded by the NIP in collaboration

with the Ministry and CDC. In FY07, because of low discordance rate between rapid testing sites and

central retesting results (0.09%), NIP has recommended that retesting moves to 5% to lower cost. Rapid

testing began in New Start VCT Centers in March 2005 followed by Ministry facilities in mid-2005. There are

now 93 sites 76 of which are certified for MoHSS and 12 sites for SMA and partners in operation. To date a

total of (777) testers were successfully trained, including health workers and community counselors. A

total of 325 new rapid testers started their certification process and 440 are certified, allowed to issue

results. From April 2007 to July 2007, 6405 tests were performed for testers' certification and 1738 tests

performed as part of the continuing quality assurance 10% retesting. During the same period, 116 sets of

EQA proficiency panels and 464 QC sets were sent out to the Rapid testing sites. The number of rapid

testing sites is expected to increase to 206 by FY07 and up to 250 by FY08. As the national health

laboratory and the sole provider of laboratory services for the MOHS, NIP plays a major role in

surveillance of HIV, STIs and TB . The rapid expansion of HIV treatment and PMTCT programs, the

acceleration of TB diagnosis requires quality Laboratory services. To comply with international quality

standards, the NIP's quality assurance department needs to be strengthened. Currently two out of the 35

laboratories have been accredited according to ISO 17025 by SANAS, and NIP is planning to have their

central reference laboratory accredited by April 2008, the remaining Labs will follow later. InCOP08 funding

is being requested for: (1) ongoing rapid testing QA support (preparation of quality controls, proficiency

panels, and to cover the costs of the ELISA tests for ongoing sampling of rapid tests performed, cover the

cost of rapid testing sites supervision); (2) Purchase small Lab equipments to strengthen the QA Laboratory

capacity; (3) continue to support salary of 6 staff (1overall QA manager, 4 QA medical technologists, 1

administrative assistant).

This continuing activity supports ARV by providing a dedicated technologist to perform viral load tests, and

relates to other NIP activities in PMTCT (7927), TB/HIV (7971), and Lab Infrastructure (7337), as well as to

Basic Care, Ministry of Health and Social Services (7331), and CDC lab infrastructure (7358). The Namibia

Institute of Pathology (NIP) is responsible at the national level for provision of all HIV-related testing

technologies for the public sector. During February 2006, the national ART treatment guidelines were

updated to include viral load testing for patients suspected to be failing treatment. With the growing number

of ARV-treated patients in Namibia, viral load testing has become an increasingly critical part of bio-clinical

monitoring. Guidelines have included more routine measurement of HIV-1 viral load at 6 months on ARV

and screening for treatment failure. With the help of USG, NIP acquired a state-of-the-art molecular biology

lab with viral load testing capacity. Anticipating increasing demand for viral load testing, the dedicated lab

technician hired and placed at NIP to perform this service will continue to be supported. It is expected that

>12,000 viral load tests will be performed in FY 2008 and this technologist is needed for the laboratory to

have sufficient capacity in response to demand. This person will be supported by the CDC laboratory

scientist assigned to the NIP.

This activity contains 3 components

(1)Namibia's antiretroviral treatment program is in its third year now and emphasis is put on bringing these

services closer to the patients in remote areas. By its mandate, NIP is required to support the treatment

program wherever it is launched. NIP will strengthen its peripheral laboratories in providing hematological

and CD4 testing to make them accessible to the patients in remote areas. That will minimize transport of

samples to central testing facilities. Funds will be allocated to purchase at least five (5) point of care CD4

machines for this purpose. Maintenance of all the equipments will be supported.

(2)Due to a lack of manpower to run the tests, testing in NIP Labs needs to be automated. This is critical

with both DNA PCR and viral load testing. The expected number of Viral Load and DNA PCR tests to be

performed in FY08 is 27,000. The DNA PCR testing using Dried Blood Spots (DBS) is still very manually

done at NIP. With the increasing number of health care workers trained on DBS collection, the rapid roll out

of Early Infants Diagnosis will challenge NIP capacity to handle the DNA PCR testing without acquiring new

equipment. The new ARV bio-clinical monitoring guidelines introduces Viral Load testing after 6 months of

treatment for all new patients starting treatment, this will also need to be automated. Funds are needed to

purchase automated system for carrying out these tests.

(3)This is an ongoing activity. An NIP laboratory training needs assessment was completed in FY06, and

recommended the creation of a training unit at NIP. During FY07 workshops and consultations were

organized with assistance of the International Laboratory Branch consortium partners. The presenting

partner was selected depending on the priorities that were identified during the laboratory training needs

assessment. Priority areas for training and consultation were laboratory management including strategic

planning for the national laboratory system (APHL); training on bio-monitoring assays such as CD4 methods

and instrumentation, chemistry and hematology (ASCP); OI focusing on tuberculosis smear microscopy,

culture and drug susceptibility testing (ASM); and standardized laboratory methodology and quality

assurance (CLSI). In FY08 support will continue to be provided to strengthen the training unit at NIP. Funds

will be allocated to purchase a vehicle as well as laboratory equipments for the hands-on training. Technical

assistance will be provided by ILB consortium partners, the RLTC while I-TECH will provide logistical

support. In FY07, USG supported the salary of the 2 technical trainers and the administrative assistant. In

FY08, USG will continue to support these salaries.