Questioning the use of materials, other than requisite Buffers, in RDTs

Donald Barrick — 2010-08-03T16:01:09Z

Your article was very helpful, in noting that manufacturers apparently do not always understand the errors made in the field. This kind of feedback is desperately required, in order to make any RDT more accurate and helpful.

The question then becomes how often the use of liquids other than the requisite Buffer occurs? This has a profound impact on how the manufacturer responds.

For example, your article noted that the RDTs used in the study apparently gave specific direction in the use of the included Buffer; however, it did not contain cautions against the use of anything other than the Buffer supplied by the manufacturers. You suggested that such a warning be included in the technical instructions, which is a task that is easily done. In response to your article, the manufacturer for whom we provide distribution, (which is not named here, so as to prevent commercialization of this commentary,) has immediately added that warning to their instructional sheets.

In a larger sense, if this is a very common field error, then a more aggressive correction may be necessary. Accordingly, the manufacturer is seeking ways to provide individualized Buffer packets, with each and every RDT, rather than in the customary vial containing Buffers for every 25 tests. However, this will certainly impact costs.

The final question then becomes whether the addition of the instuctional warning is sufficient, or whether the volume of field errors are sufficiently numerous to demand a change in packaging, and whether the market will deem the added cost to be worthwhile.

Your comments are welcome, with thanks.

Article Comments - 'Buffer substitution in malaria rapid diagnostic tests causes false-positive results '

Questioning the use of materials, other than requisite Buffers, in RDTs