Hybrid Capture 2 (HC2) was the first FDA approved HPV test in early 2000s, but for multiple years this technology was cost prohibitive for low and middle-income countries (LMICs). Due to the need of having a more affordable HPV test, the careHPV test was developed by Qiagen with support from PATH and the Bill and Melinda Gates foundation. This technology does not require running water, air conditioning or sophisticated lab infrastructure. (Figures 1 and 2) Processing careHPV testing has been relatively easy to learn and implement by different health system providers including cytologists and laboratory technicians. The other major advantage is that the price of the test is expected to be in the range of ~5 dollars per test, with proven quality standards.

The 2013 WHO Guidelines include HPV testing for primary screening, and a variety of follow-up options for HPV positive women, and countries can now consider restructuring their national programs using HPV testing. The high sensitivity of the test allows increasing the screening intervals, and provides an opportunity to increase coverage in high-risk populations by using self-collected vaginal samples. Self-collection of vaginal samples can be done within the privacy of their home, close to their work places, or other facilities in the community. Our experience with the careHPV test is based on the implementation of HPV testing we are doing in Guatemala and El Salvador.^1,2 These are essential projects because it is the first time in LMICs that HPV testing is being implemented in their public health systems through national governments. The experience that the Central American countries are obtaining with the introduction of careHPV in their public systems gives us the opportunity to identify some advantages and limitations when working with that test.

FIGURE 1 Laboratory technician running careHPV in Guatemala.

FIGURE 2 Laboratories in many developing countries often have very limited infrastructure and resources.

Advantages of the careHPV test
A screening test for LMICs must be simple to implement, accepted by the users, and economically sustainable. Currently the careHPV test is the only test that has been proven to have such characteristics. “

Cost
The cost of the careHPV is one of the biggest advantages and should be independently analyzed at the time of implementing a strategy for screening of cervical cancer with DNA tests in places where resources are limited. In addition the cost of a screening program could also be influenced by the self-sampling strategy, which allows for the reduction of other costs associated with sample collection (speculum, gloves and personnel time). Several studies have shown that careHPV testing with proper follow up is a very cost effective option.

Adaptability
In our experience, the technology is easily adapted to laboratories in different localities, even in places where there is not an actual laboratory. The minimum requirements for the testing site consist of a table of 2 meters by 60 centimeters, three electrical outlets, a backup battery and a chair.
The learning curve for technicians in the processing of the tests has been easily achieved during training. Multiple healthcare professionals have been trained in our countries, including lab oratory technicians and cytotechnologists. Trained technicians have also shown that competencies are also easily replicable in training. We want to emphasize the importance of self-sampling in a population-based national screening program. Self-sampling closes many of the cultural, behavioral and practical gaps that are found in cervical cancer screening, improves adherence to screening, and facilitates access to screening overcoming limitations such as distance to health facilities, lack of transportation to health services, work schedule conflicts, shame of pelvic exams, etc. Self-sampling with careHPV is accepted by 76% of women in Guatemala (4).
Finally, our experience shows the need to pilot or demonstrate feasibility within a country, which is essential in order to learn as the intervention grows in scale. It is crucial to emphasize that even though there are new options for screening, it is as important to ensure that proper management must be conducted for HPV positive women. Now with the new WHO Guidelines as a reference, HPV screening and follow up algorithms can be assessed based on each country’s resources.

References

1. Cremer ML. Introducing a High-Risk HPV DNA Test In to a Public Sector Screening Program in El Salvador. J Low Genit Tract Dis. 2016 Feb 17 [Epub ahead of print] PMID: 26890683
2. Jeronimo J. Implementation of HPV testing in Latin America. J Clin Virol. 2015 Nov 28. pii: S1386-6532(15)00779-9. doi: 10.1016/j.jcv.2015.11.035. [Epub ahead of print] Review.
3. Campos NG. Cancer. 2015 Aug 15;137(4):893-902. doi: 10.1002/ijc.29438. Epub 2015 Feb 3.PMID:25639903
4. Indicadores tamizaje con pruebas de ADN, método care HPV, fase piloto, Ministerio de Salud Pública y Asistencia Social, Programa Nacional de Salud Reproductiva, Componente Cáncer, enero de 2016.