[310595]
Reporter ran the chlamydia assay. The run was invalid because the difference in absorbance readings for the positive control and the negative control must be at least 0. 800. This run did not meet that criteria. Reporter repeated the run with a new kit, same lot number and fortunately was able to obtain a valid run. Reporter did some further investigation into this problem as they had been concerned in the decreased readings for a couple of weeks even though all preventive maintenance and quality assurance was indicating everything was working as it should. Upon investigation found that there had been a significant decrease in the absorbance readings for the positive control after beginning this current lot number of product. Reporter contacted wampole and discussed this with technical services. They had received a few other telephone calls regarding the same problem and had discussed it with the mfr, trinity. The conclusion was that the positive control was not "positive enough" and that trinity was "working on it". They assured reporter that the remainder of the kit was fine. They suggested that reporter use a known positive pt in lieu of positive control. Since this method change is not approved by fda, reporter requested documentation from the co. Reporter was told they could not send them anything in writing. After further review of previous testing done in comparison to the use of the previous lot number, reporter found there to be a significant decrease in readings overall. Up until the use of this lot number reporter was obtaining a minimum of 4 to 5 positive pt tests per run. Now they have an average of 0 to 2 per run. Reporter has had as many as 11 positive pts in a run. In the 13 years that reporter has used this assay, there are usually only 2 or 3 runs per year that they have no positive tests at all. Thus far for the month of january reporter has already had 3 runs with no new positive tests. Very unusual. The definitely sent up a red flag. Reporter again contacted wampole to discuss the issues with them again. They expressed their concern that the problem may not necessarily be the positive control alone, but the reagent in the kit. They have requested that reporter submit readings from runs with the current lot number as well as the previous lot number for comparison which reporter complied. Just to throw another wrench into the works, reporter had to swap out reader at the beginning of november. They observed a drop in readings at that time as well, but not as significant a drop as they are seeing with the lot number change. Instrument tech services does not believe the reader is causing the problem. Wampole tech services has contacted trinity and they have not responded to the problem. Unfortunately, this co is based in ireland. Wampole has said that their hands are tied as a result. Wampole reports that they do not have stock of a different lot number. Reporter contacted technical services again to ask them to locate another kit with a different lot number from another user and have it shipped so that reporter may do their own side by side testing to check the differences in absorbance readings as well as cross check the positive controls between the kits. Cooperation remains low. Reporter also contacted their sales rep and had to leave a message. Reporter demanded that they rattle someone's cage on his end as well due to the concern that rptr has regarding turning out invalid test results, i. E. Potentially missing positives. Later in the day sales rep reported that he has test kits in stock with the same lot number, but was not releasing them until trinity sent a new positive control to swap out in the test kits. With this knowledge, reporter would assume that wampole and/or trinity would contact all of their users and issue a recall. However, nothing has been done.
Patient Sequence No: 1, Text Type: D, B5