Together with considerations of the sensitivity, species of parasite detected, and cost of a product, it is useful to know the quality of manufacturing processes and the stability of a manufacturer. The long-term viability of a company and consistency of production will influence the ability to replace a product should the received lot fail, and to ensure long-term supply of a product to minimize the need for re-training.
It is therefore recommended that purchasers request the following information from manufacturers during the tendering process:
1. Real-time temperature stability data on the product, and accelerated data on the purchased lot
2. Evidence of successful operational use, or good quality field data on the product
3. Evidence of long-term viability of manufacturer (to ensure continuity of supply)
4. Evidence of Good Manufacturing Practice /ISO certification(ISO13485:2003is specific for quality management systems for medical devices)
5. Availability of product support
6. Provision of sample products for assessment and testing for ease of use
7. Agreement for replacement of products which fail agreed quality control procedures (see above)
8. Box sizes appropriate to the rate of use of tests in the intended area, to minimize storage time in poor conditions and reduce the need to split boxes.
Points 3 and 4 imply that the place of manufacture of RDTs should be disclosed to the purchaser if RDTs are re-labelled.
Clarity of packaging of the end product is essential to allow identification of product type, production lots and expiry date.