Policy Guidelines on HCV Testing Report of an Informal Consultation, New Delhi, 21–22 December 1999

Recommendations

 

*     To Member Countries

 

*     Epidemiology

 

a)      Available data from SEAR countries indicate hepatitis C to be a major problem with unsafe blood as the most important mode of transmission. The data need further refinement for the precise quantification of disease burden, better elucidation of disease epidemiology, especially the geographical mapping, and the age-sex stratification of the carriers. An effective surveillance system needs to be launched by the Member Countries. Multi-centric community-based studies may also be undertaken to ascertain the prevalence of hepatitis C carriers in the countries.

 

*     Prevention of transmission of HCV from blood, blood components, organs, tissues and semen

 

a)      Rigid criteria for the selection of voluntary donors must be developed and strictly implemented so as to eliminate potentially infected sources of unsafe blood.

b)      Testing for anti-HCV antibody must be made mandatory in all the blood banks as early as possible to reduce the burden of HCV and cut short one of the important modes of transmission of this infection.

c)      Testing for anti-HCV antibody should be part of the integrated blood safety procedures along with testing for HIV, hepatitis B surface antigen, antitreponemal antibody and malarial parasite.

d)      Existing WHO guidelines on safety in the preparation of plasma products inclusive for hepatitis C should be scrupulously followed.

e)      All donors of organs/tissues/semen should be tested for HCV antibody and those that are reactive for HCV should not be utilized for transplantation.

f)       A system of sentinel surveillance to monitor post-transfusion infection due to HCV should be developed.

 

*     Prevention of HCV transmission from high-risk procedures/practices

 

a)      Universal precautions for infection control must be integrated in the routine working of all health care workers and those who are pursuing research in university and R&D settings in order to avoid occupational and nosocomial transmission of HCV besides HIV and hepatitis B virus.

b)      Use of disposable/sterile syringes and instruments, safe injection practices, proper sterilization techniques, avoiding reuse and sharing of contaminated equipment and supplies both in the field and in health care institutions must be strictly adhered to.

c)      Comprehensive health education messages for the prevention of blood borne infections, especially hepatitis B and C viruses, must be included in ongoing IEC campaigns against HIV.

 

*      Screening for Hepatitis C

 

a)     For mandatory HCV screening in blood banks, at least third-generation anti-HCV EIA test with kits of a quality approved by the national control authority should be used.

b)     The procedures adopted for HIV kits may be adapted to purchase kits for hepatitis C as well as hepatitis B surface antigen to ensure the quality of the kits and, their uniformity, as well as to bring down the cost.

c)      In emergency situations where EIA test is not possible, a rapid test with specifications approved by the National Control Authority should be used.

d)     Evaluation of the kits should be undertaken by accredited national/regional laboratories to assess the quality of the HCV kits before these are purchased.

e)     The quality assurance programme for the evaluation of the kits should be strengthened.

f)       Designated laboratories may undertake molecular biological studies to correlate findings based on serological studies as well as for the confirmation of representative HCV-reactive sera.

 

*     Training and Quality Assurance

 

a)      Training of laboratory functionaries in blood banks should precede the implementation of the national policy for mandatory testing for HCV. The training should be comprehensive from the blood banks’ mandatory points of view and not in isolation for HCV testing alone. Issues such as biosafety should be given adequate importance. In countries with a large number of blood banks, the quality of training and curriculum and should be uniform and should be developed after assessing the training needs of the users. The training can be expedited by organizing it at various locations with one national institution coordinating the activity

b)      An External Quality Assessment Scheme (EQAS) should be in place to ensure quality of results by the blood banks. The staff of blood banks should also be trained in, and encouraged to undertake, internal audit.

 

*     National Control Authority

 

a)      Functionaries of the national control authority should be trained in various regulatory aspects of blood banking to ensure effective supervision of blood banks in their domain.

b)      The national control authority should also ensure procurement of quality kits and coordinate blood safety as a whole with suitable components of training and quality assurance programmes.

c)      National/regional laboratories should be identified for supporting national control laboratories and undertaking EQAS.

 

*     To WHO

 

*     WHO/SEARO should provide all technical back-up for the implementation of activities related to hepatitis C testing.

*     WHO should provide technical support in training national trainers as well as national regulatory authority professionals for the effective implementation of the national policy of ensuring safe blood supply.

*     WHO should assist Member Countries in initiating national external quality assessment schemes (NEQAS) for the testing of blood for transmissable agents. It should also assist national laboratories in participating in international external quality assessment schemes (IEQAS).

*     WHO should support countries in the evaluation of kits, choice of kit reagents and supply of standard strains.

 

 

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