Development and challenge of HIV/AIDS testing laboratory network and quality assurance system in China

This paper describes the development and challenge of HIV/AIDS testing laboratory network and quality assurance system in China. At present, the HIV/AIDS testing laboratories includes three classes, the National AIDS Reference Laboratory, HIV/AIDS confirmatory laboratories and HIV/AIDS screening laboratories. All of them are accredited by the health authorities, and each class of laboratories take charge of their function strictly according to the “National Management of HIV/AIDS Detection (2006)”. A complete quality assurance and quality control system for HIV/AIDS testing has been developed, which includes technical training, strict laboratory monitoring and approval, examination or proficiency testing on HIV/AIDS detection, and quality evaluation and supervision of HIV/AIDS diagnostic kits. Besides conduct the routine anti-HIV antibody test, more and more laboratories began to conduct other tests, such as CD4⁺T lymphocyte cell counting, HIV viral load, HIV DNA PCR, genotyping, drug resistance, and HIV-1 recent infection test. The primary challenges faced by the HIV/AIDS testing laboratory network are in the areas of laboratory management and quality control. For example, the provincial PT program is inefficient, the internal quality control is conducted perfunctorily, personnel training can not met the needs of the workplace, which need to be improved. Foundation item: MOH Program on Applied Research in the Prevention and Treatment of AIDS (WA 2003-17)     

External Quality Assessment for Tuberculosis Diagnosis and Drug Resistance in the European Union: A Five Year Multicentre Implementation Study

BackgroundExternal quality assurance (EQA) systems are essential to ensure accurate diagnosis of TB and drug-resistant TB. The implementation of EQA through organising regular EQA rounds and identification of training needs is one of the key activities of the European TB reference laboratory network (ERLTB-Net). The aim of this study was to analyse the results of the EQA rounds in a systematic manner and to identify potential benefits as well as common problems encountered by the participants.MethodsThe ERLTB-Net developed seven EQA modules to test laboratories’ proficiency for TB detection and drug susceptibility testing using both conventional and rapid molecular tools. All National TB Reference laboratories in the European Union and European Economic Area (EU/EEA) Member States were invited to participate in the EQA scheme.ResultsA total of 32 National TB Reference laboratories participated in six EQA rounds conducted in 2010–2014. The participation rate ranged from 52.9% - 94.1% over different modules and rounds. Overall, laboratories demonstrated very good proficiency proving their ability to diagnose TB and drug-resistant TB with high accuracy in a timely manner. A small number of laboratories encountered problems with identification of specific Non-tuberculous Mycobacteria (NTMs) (N = 5) and drug susceptibility testing to Pyrazinamide, Amikacin, Capreomycin, and Ethambutol (N = 4).ConclusionsThe European TB Reference laboratories showed a steady and high level of performance in the six EQA rounds. A network such as ERLTB-Net can be instrumental in developing and implementing EQA and in establishing collaboration between laboratories to improve the diagnosis of TB in the EU/EEA.     

An Integrated Tiered Service Delivery Model (ITSDM) Based on Local CD4 Testing Demands Can Improve Turn-Around Times and Save Costs whilst Ensuring Accessible and Scalable CD4 Services across a National Programme

Background

The South African National Health Laboratory Service (NHLS) responded to HIV treatment initiatives with two-tiered CD4 laboratory services in 2004. Increasing programmatic burden, as more patients access anti-retroviral therapy (ART), has demanded extending CD4 services to meet increasing clinical needs. The aim of this study was to review existing services and develop a service-model that integrated laboratory-based and point-of-care testing (POCT), to extend national coverage, improve local turn-around/(TAT) and contain programmatic costs.

Methods

NHLS Corporate Data Warehouse CD4 data, from 60–70 laboratories and 4756 referring health facilities was reviewed for referral laboratory workload, respective referring facility volumes and related TAT, from 2009–2012.

Results

An integrated tiered service delivery model (ITSDM) is proposed. Tier-1/POCT delivers CD4 testing at single health-clinics providing ART in hard-to-reach areas (<5 samples/day). Laboratory-based testing is extended with Tier-2/POC-Hubs (processing ≤30–40 CD4 samples/day), consolidating POCT across 8–10 health-clinics with other HIV-related testing and Tier-3/‘community’ laboratories, serving ≤40 health-clinics, processing ≤150 samples/day. Existing Tier-4/‘regional’ laboratories serve ≤100 facilities and process <350 samples/day; Tier-5 are high-volume ‘metro’/centralized laboratories (>350–1500 tests/day, serving ≥200 health-clinics). Tier-6 provides national support for standardisation, harmonization and quality across the organization.

Conclusion

The ITSDM offers improved local TAT by extending CD4 services into rural/remote areas with new Tier-3 or Tier-2/POC-Hub services installed in existing community laboratories, most with developed infrastructure. The advantage of lower laboratory CD4 costs and use of existing infrastructure enables subsidization of delivery of more expensive POC services, into hard-to-reach districts without reasonable access to a local CD4 laboratory. Full ITSDM implementation across 5 service tiers (as opposed to widespread implementation of POC testing to extend service) can facilitate sustainable ‘full service coverage’ across South Africa, and save>than R125 million in HIV/AIDS programmatic costs. ITSDM hierarchical parental-support also assures laboratory/POC management, equipment maintenance, quality control and on-going training between tiers.     

Laboratory technicians; the Clinical Laboratory Law and its meaning to private physicians

The present laws and regulations relating to clinical laboratories in California are the outcome of over a quarter century of cooperative development. The medical profession, public health department, laboratory workers, and the legislature have worked together in this development.At first the system of certifying technicians and laboratories was on a voluntary basis. The clinical laboratory law in effect legalized and made generally applicable a system which had already been accepted voluntarily. The application of the clinical laboratory law provides physicians a reasonable assurance that competence and reliability will prevail in clinical laboratory operation. Of great importance is the conduct of proper training programs by approved laboratories. Since modern medical practice is so dependent on accurate clinical laboratory work it is essential that special effort be directed by physicians toward influencing young people to enter the profession of medical technology.     

Evaluation of the system for controlling the quality of the HBsAg detection in the system of screening laboratories

The two-stage control system, ensuring the high quality of serological investigations in the network of screening laboratories in Moscow was developed and introduced into practice. At the first stage the entry control of the quality of the test system for the detection of HbsAg, coming to the screening laboratories, is made in the reference laboratory with the use of specially developed "representative" panels, as well as the test systems for comparison ("reference" test systems). Then "minipanels" are formed from specimens included into the "representative" panels, which are used for the evaluation of the quality of laboratory investigations made in the screening laboratories. The high quality of such system for controlling the quality of the detection of HBsAg in the screening laboratories of Moscow is shown.     

Quality Assurance and Standardization in Immunohistochemistry. A Proposal for the Annual Meeting of the Biological Stain Commission,June, 1991

Quality assurance, quality control, proficiency testing, reagent documentation and validation are standard parts of everyday practice in clinical laboratories throughout the United States. Immunohistochemical stains employ reagents and principles in common with immunoenzyme methods utilized in the clinical laboratory. However, immunohistochemistry has not routinely been subjected to similar standardization and quality assurance procedures that manufacturers and pathologists alike have applied to essentially the same techniques in the clinical laboratory environment. The current proposal was invited by the Biological Stain Commission with the charge of incorporating the findings of previous workshops on quality control in immunohistochemistry into a practical design for implementation. The status of quality assurance, quality control and standardization in immunohistochemistry is reviewed and a phased strategy for implementation is proposed.     

Quality Assurance and Standardization in Immunohistochemistry. A Proposal for the Annual Meeting of the Biological Stain Commission, June, 1991

Quality assurance, quality control, proficiency testing, reagent documentation and validation are standard parts of everyday practice in clinical laboratories throughout the United States. Immunohistochemical stains employ reagents and principles in common with immunoenzyme methods utilized in the clinical laboratory. However, immunohistochemistry has not routinely been subjected to similar standardization and quality assurance procedures that manufacturers and pathologists alike have applied to essentially the same techniques in the clinical laboratory environment. The current proposal was invited by the Biological Stain Commission with the charge of incorporating the findings of previous workshops on quality control in immunohistochemistry into a practical design for implementation. The status of quality assurance, quality control and standardization in immunohistochemistry is reviewed and a phased strategy for implementation is proposed.     

Development of Veterinary Laboratory Networks for Avian Influenza and Other Emerging Infectious Disease Control: The Southeast Asian Experience

The outbreak of highly pathogenic H5N1 avian influenza, with its international spread, confirmed that emerging infectious disease control must be underpinned by effective laboratory services. Laboratory results are the essential data underpinning effective surveillance, case diagnosis, or monitoring of responses. Importantly, laboratories are best managed within national and international networks of technological support rather than in isolation. A well planned laboratory network can deliver both a geographical spread of testing capacity and also a cost effective hierarchy of capability. Hence in the international context regional networks can be particularly effective. Laboratories are an integral part of a country’s veterinary services and their role and function should be clearly defined in the national animal health strategy and supporting government policies. Not every laboratory should be expected to deliver every possible service, and integration into regional and broader international networks should be a part of the overall strategy. The outputs required of each laboratory should be defined and then ensured through accredited quality assurance. The political and scientific environment in which laboratories operate changes continuously, not only through evolving national and regional animal health priorities but also through new test technologies and enhancements to existing technologies. Active networks help individual laboratories to monitor, evaluate, and respond to such challenges and opportunities. The end result is enhanced emerging infectious disease preparedness across the region.     

International technology transfer of a GCLP-compliant HIV-1 neutralizing antibody assay for human clinical trials

The Collaboration for AIDS Vaccine Discovery/Comprehensive Antibody-Vaccine Immune Monitoring Consortium (CAVD/CA-VIMC) assisted an international network of laboratories in transferring a validated assay used to judge HIV-1 vaccine immunogenicity in compliance with Good Clinical Laboratory Practice (GCLP) with the goal of adding quality to the conduct of endpoint assays for Human Immunodeficiency Virus I (HIV-1) vaccine human clinical trials. Eight Regional Laboratories in the international setting (Regional Laboratories), many located in regions where the HIV-1 epidemic is most prominent, were selected to implement the standardized, GCLP-compliant Neutralizing Antibody Assay for HIV-1 in TZM-bl Cells (TZM-bl NAb Assay). Each laboratory was required to undergo initial training and implementation of the immunologic assay on-site and then perform partial assay re-validation, competency testing, and undergo formal external audits for GCLP compliance. Furthermore, using a newly established external proficiency testing program for the TZM-bl NAb Assay has allowed the Regional Laboratories to assess the comparability of assay results at their site with the results of neutralizing antibody assays performed around the world. As a result, several of the CAVD/CA-VIMC Regional Laboratories are now in the process of conducting or planning to conduct the GCLP-compliant TZM-bl NAb Assay as an indicator of vaccine immunogenicity for ongoing human clinical trials.     

Obtaining valid laboratory data in clinical trials conducted in resource diverse settings: lessons learned from a microbicide phase III clinical trial

Background

Over the last decade several phase III microbicides trials have been conducted in developing countries. However, laboratories in resource constrained settings do not always have the experience, infrastructure, and the capacity to deliver laboratory data meeting the high standards of clinical trials. This paper describes the design and outcomes of a laboratory quality assurance program which was implemented during a phase III clinical trial evaluating the efficacy of the candidate microbicide Cellulose Sulfate 6% (CS) [1].

Methodology

In order to assess the effectiveness of CS for HIV and STI prevention, a phase III clinical trial was conducted in 5 sites: 3 in Africa and 2 in India. The trial sponsor identified an International Central Reference Laboratory (ICRL), responsible for the design and management of a quality assurance program, which would guarantee the reliability of laboratory data. The ICRL provided advice on the tests, assessed local laboratories, organized trainings, conducted supervision visits, performed re-tests, and prepared control panels. Local laboratories were provided with control panels for HIV rapid tests and Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG) amplification technique. Aliquots from respective control panels were tested by local laboratories and were compared with results obtained at the ICRL.

Results

Overall, good results were observed. However, discordances between the ICRL and site laboratories were identified for HIV and CT/NG results. One particular site experienced difficulties with HIV rapid testing shortly after study initiation. At all sites, DNA contamination was identified as a cause of invalid CT/NG results. Both problems were timely detected and solved. Through immediate feedback, guidance and repeated training of laboratory staff, additional inaccuracies were prevented.

Conclusions

Quality control guidelines when applied in field laboratories ensured the reliability and validity of final study data. It is essential that sponsors provide adequate resources for implementation of such comprehensive technical assessment and monitoring systems.

Trial Registration

ClinicalTrials.gov {"type":"clinical-trial","attrs":{"text":"NCT00153777","term_id":"NCT00153777"}}NCT00153777 and Current Controlled Trials ISRCTN95638385     

Quality control of CD4+ T-lymphocyte enumeration: results from the last 9 years of the United Kingdom National External Quality Assessment Scheme for Immune Monitoring (1993-2001)

The human immunodeficiency virus (HIV) global epidemic has necessitated the routine enumeration of T-lymphocyte subsets, which has created a need for external quality assurance (EQA). The United Kingdom National External Quality Assessment Scheme (UK NEQAS) for Immune Monitoring provides EQA for 296 laboratories in 40 countries. In 1993, UK NEQAS developed and incorporated into its program stabilized whole blood that enables the accurate monitoring of laboratory performance. Overall, the mean interlaboratory coefficient of variation (CV) for percentage CD4(+) T-lymphocyte subset enumeration has fallen from 15% to less than 5%, as a direct result of the increased use of CD45/ side scatter (SSC) gating. Laboratories using alternative gating strategies (i.e., CD45/CD14 or forward scatter [FSC]/SSC) were about 7.4 times more likely to fail an EQA exercise. Furthermore, the adoption of single-platform technology resulted in a reduction of the overall mean interlaboratory CV for absolute CD4(+) T lymphocytes from 56% (prior to the widespread use of single-platform technology) to 9.7%. Individual laboratory deficiencies were also identified using a performance monitoring system and, through re-education by collaboration with the coordinating center, satisfactorily resolved. In conclusion, during the last 9 years, the UK NEQAS for Immune Monitoring program has highlighted the significant technological advances made by laboratories worldwide that undertake lymphocyte subset enumeration.     

Toward implementation of a regional quality assurance program in cytopathology: the Hong Kong experience

OBJECTIVE: To develop a local quality assurance program in cytopathology based on circulation of patient specimens on glass slides, with limited resources. STUDY DESIGN: A working group was set up for design and running of the program. Participation is on a laboratory basis. The scope and frequency of testing are defined. Well-documented cases (including gynecologic, nongynecologic and fine needle aspiration cytology) with commonly encountered diagnoses are collected. Consensus concerning the diagnosis, interpretive menu and scoring system is sought before the actual slide circulations using express mail. After returning their answers to the program organizer, the participating laboratories receive immediate feedback on their scores, with reference answers, explanatory notes, "whole-mount" images of glass slides and cumulative responses of peer laboratories for on-site checking. At the end of each year, an electronic file containing representative photomicrographs of all cases examined is provided to individual laboratories for their permanent records and training purposes. RESULTS: The program was launched in mid-2003. There were 24 and 27 participating laboratories from Hong Kong (and Macau) in 2003 and 2004, respectively. To date, >150 well-documented cytology cases are available in the slide pool and ready for circulation. As the revenue is mainly to cover the expenses of express mail, the program can be carried out at a relatively low cost. CONCLUSION: In order to have any cytology quality assurance program accepted by local laboratories, it has to be fair and practical. Strict confidentiality needs to be observed throughout the process. This program emphasizes both performance assessment and educational value. Adequate representation from experienced local cytology workers, detailed documentation support from authorities and assistance from dedicated staff are essential to the success of any external proficiency testing scheme. Regular review and evaluation are also necessary for continuous improvement. The Hong Kong experience can serve as an example of running a glass slide-based cytology quality assurance program in a small region with limited resources.     

Task-Shifting and Quality of HIV Testing Services: Experiences from a National Reference Hospital in Zambia

Background

With new testing technologies, task-shifting and rapid scale-up of HIV testing services in high HIV prevalence countries, assuring quality of HIV testing is paramount. This study aimed to explore various cadres of providers’ experiences in providing HIV testing services and their understanding of elements that impact on quality of service in Zambia.

Methods

Sixteen in-depth interviews and two focus group discussions were conducted with HIV testing service providers including lay counselors, nurses and laboratory personnel at purposively selected HIV testing sites at a national reference hospital in Lusaka. Qualitative content analysis was adopted for data analysis.

Results

Lay counselors and nurses reported confidentiality and privacy to be greatly compromised due to limited space in both in- and out-patient settings. Difficulties in upholding consent were reported in provider-initiated testing in in-patient settings. The providers identified non-adherence to testing procedures, high workload and inadequate training and supervision as key elements impacting on quality of testing. Difficulties related to testing varied by sub-groups of providers: lay counselors, in finger pricking and obtaining adequate volumes of specimen; non-laboratory providers in general, in interpreting invalid, false-negative and false-positive results. The providers had been participating in a recently established national HIV quality assurance program, i.e. proficiency testing, but rarely received site supervisory visits.

Conclusion

Task-shifting coupled with policy shifts in service provision has seriously challenged HIV testing quality, protection of confidentiality and the process of informed consent. Ways to better protect confidentiality and informed consent need careful attention. Training, supervision and quality assurance need strengthening tailored to the needs of the different cadres of providers.     

Virginity Testing: Managing Sexuality in a Maturing HIV/AIDS Epidemic

KwaZulu-Natal province in South Africa is currently the site of the world's fastest growing HIV/AIDS epidemic, where it is estimated that between 30 and 40 percent of the adult population is seropositive for HIV. With support from local politicians and members of various government ministries, several self-styled guardians of tradition have emerged to form organizations that advocate and conduct regular virginity testing of girls. Reference to the current HIV/AIDS epidemic is central to calls for greater support of this practice. Drawing on original research among Zulu-speaking people in the periurban communities of Durban, this article examines the sociocultural construction of HIV/AIDS and locates the growing popularity of virginity testing within a gendered meaning-making process consistent with commonly held beliefs that the epidemic is the result of women being sexually "out of control." With the social impact of AIDS starting to take its toll in the forms of increasing AIDS-related deaths and a growing population of orphans, I argue that virginity testing is an attempt to manage the epidemic by exerting greater control over women and their sexuality. In addition, virginity testing of girls helps to draw attention away from the role of men in the maturing epidemic, consideration of which has been conspicuously absent in the popular discourse on AIDS at all levels of South African society.     

Cervical cytology quality assurance in Washington State.

The objectives of this study were to establish a profile of cervical cytology laboratories in Washington State, identify quality assurance problems amenable to correction through education or legislation, and describe differences between large and small cytology laboratories. All 43 Washington laboratories that perform cervical cytology were surveyed by mail during 1989. Completed surveys were returned by 37 (86%) of the laboratories. Nearly half (43%) of the respondents reported processing less than 10,000 Papanicolaou smears annually. Only one-third (35%) of the respondents reported participating in relevant proficiency programs. A proportion of smaller cytology laboratories were compensating their cytotechnologists on the basis of the number of slides read and allowing Papanicolaou smears to be read outside the confines of the laboratory. The results of this study suggest that cytotechnologists in some larger Washington laboratories have been exceeding work load limits recommended by professional associations. Recent legislation includes regulations that address cervical cytology quality assurance. However, continued efforts will need to be made to encourage voluntary adoption of quality control measures not addressed by this legislation.     

An international proficiency study with the tumor marker CA 125

A strict and adequate quality assurance program is the only real guarantee of the reliability of laboratory test results. Such proficiency testing was carried out for the CA 125 test system in five university laboratories over a period of three years (1984-1987) using five different reference materials (BIOREF, FRG). A concentration-dependent performance profile could thus be established evaluating a total of 301 assays. Intra-assay precision of the test ranged between 4.8 and 11.5%, and interassay precision between 13.6 and 19.1%. Laboratory specific average values of the individual reference materials ranged between 26 and 32 U/ml for reference 1, 51 and 59 U/ml for reference 2, 109 and 121 U/ml and 193 to 240 U/ml for references 3 and 4, respectively. Mean values for reference 5 ranged between 401 and 458 U/ml. There was no significant difference between mean values for the laboratories. Considerable batch-dependent variations of values became evident during the study but these were not indicated by the kit control supplied by the manufacturer. During the whole investigation period no systematic drift in values could be observed using trend analysis, indicating excellent stability of the reference material if stored frozen (-20 degrees C).     

Photographed rapid HIV test results pilot novel quality assessment and training schemes

HIV rapid diagnostic tests (RDTs) are now used widely in non-laboratory settings by non-laboratory-trained operators. Quality assurance programmes are essential in ensuring the quality of HIV RDT outcomes. However, there is no cost-effective means of supplying the many operators of RDTs with suitable quality assurance schemes. Therefore, it was examined whether photograph-based RDT results could be used and correctly interpreted in the non-laboratory setting. Further it was investigated if a single training session improved the interpretation skills of RDT operators. The photographs were interpreted, a 10-minute tutorial given and then a second interpretation session was held. It was established that the results could be read with accuracy. The participants (n=75) with a range of skills interpreted results (>80% concordance with reference results) from a panel of 10 samples (three negative and seven positive) using four RDTs. Differences in accuracy of interpretation before and after the tutorial were marked in some cases. Training was more effective for improving the accurate interpretation of more complex results, e.g. results with faint test lines or for multiple test lines, and especially for improving interpretation skills of inexperienced participants. It was demonstrated that interpretation of RDTs was improved using photographed results allied to a 10-minute training session. It is anticipated that this method could be used for training but also for quality assessment of RDT operators without access to conventional quality assurance or training schemes requiring wet samples.     

Risks faced by laboratory workers in the AIDS era.

Laboratory workers are at occupational risk of exposure to microrganisms that cause a wide variety of diseases, from inapparent to life-threatening ones. Principal routes of transmission include percutaneous and permucosal inoculation (comprising clinical inapparent cutaneous or mucosal exposure to blood or blood products), inhalation, and ingestion. The appearance of the Acquired Immunodeficiency Syndrome (AIDS) epidemic and the first reports of occupational Human Immunodeficiency Virus (HIV) infections in health care workers resulted in high anxiety among laboratory workers. Indeed, 21% of worldwide documented cases of occupational HIV infection occurred among laboratory workers. Research laboratories pose the highest risk of infection. Safe methods for managing infectious agents ("containment") in the laboratory setting include laboratory practice and technique, safety equipment, and facility design. Infection control in the laboratory setting should take into account adherence to guidelines (biosafety levels), education and training, and the development of safety products designed to reduce the risk of exposure.     

Results of an innovative education, training and quality assurance program for point-of-care HbA1c testing using the Bayer DCA 2000 in Australian Aboriginal Community Controlled Health Services

This study describes the development, implementation and management of a multi-faceted quality assurance program called Quality Assurance for Aboriginal Medical Services (QAAMS) to support point-of-care HbA(1c) testing on the Bayer DCA 2000 in Aboriginal people with diabetes from 45 Australian Aboriginal Community Controlled Health Services.THE QUALITY ASSURANCE PROGRAM COMPRISED FOUR ELEMENTS: production of culturally appropriate education resources, formal training for Aboriginal Health Workers conducting HbA(1c) testing, an external quality assurance program and on-going quality management support services including a help hotline and an annual workshop. Aboriginal Health Workers were required to test two quality assurance (QAAMS) samples in a blind sense every month since July 1999. Samples were linearly related and comprised six paired levels of HbA(1c). The short and long term performance of each service's DCA 2000 was reviewed monthly and at the end of each six month testing cycle.The average participation rate over 7 six-monthly QAAMS testing cycles was 88%. 84% of 3100 quality assurance tests performed were within preset limits of acceptability. The median precision (CV%) for HbA(1c) testing has averaged 3.8% across the past 5 cycles (range 3.4 to 4.0%) and is continuing to improve. The introduction of a medical rebate for HbA(1c) testing has ensured the program's sustainability.Through continuing education and training, Aboriginal Health Workers have achieved consistent analytical performance for HbA(1c) testing on the DCA 2000, equivalent to that of laboratory scientists using the same instrument. This unique quality assurance model can be readily adapted to other Indigenous health settings and other point-of-care tests and instruments.     

Molecular diagnosis of HIV and relevant novel technologies in mutation analysis

HIV infection is one of the major threats to human health due to the lack of relevant vaccine and drugs to cure AIDS. Its early diagnosis is thus important in controlling HIV transmission. Molecular diagnosis of HIV can be performed qualitatively and quantitatively. Currently, molecular diagnosis of HIV infection is only used as a complementary diagnosis although viral load test is used to monitor disease progression and responsiveness to antiviral therapy. To optimize HIV assays, a variety of technological advances, such as the introduction of dUTP/UNG system, real-time detection platform, and coupling of more than one enzyme in molecular identification, have been integrated into new methods. With the development of more reliable HIV assays in the future, the molecular diagnosis of HIV is expected to be accepted as one of the standards in determining whether there is a HIV infection in resource-rich laboratories, which will play a crucial role in reducing HIV transmission.