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Several Violations of Violations of In Vitro Diagnostic Reagents

1. In vitro diagnostic reagents are used in conjunction with unmatched diagnostic instruments

After some medical institutions purchase diagnostic instruments, because the cost of using the in vitro diagnostic reagents matching the diagnostic instruments is very high, they often buy cheap similar in vitro diagnostic reagents instead. In some cases, in vitro diagnostic reagents of similar varieties cannot match the diagnostic instrument, and such use cannot guarantee the accuracy of the test data.

2. Changing the qualitative detection of in vitro diagnostic reagents to quantitative detection without authorization

When some in vitro diagnostic reagents are approved, they are only approved as qualitative detection reagents. Such as the hepatitis B virus detection kit, in addition to surface antigen and serum DNA quantitative detection has clinical significance, the clinical detection significance of quantitative detection of other indicators is less than the research significance, so the hepatitis B virus detection kit except surface antigen, others, such as the hepatitis B virus core antigen detection kit, are less likely to be approved as quantitative kits. However, because the clinical testing charges for quantitative testing are much higher than those for qualitative testing, some manufacturers have changed the qualitative kits to quantitative kits without the approval of quantitative testing kits.

3. Use expired in vitro diagnostic reagents

Some in vitro diagnostic reagents are not valid for a long period, and even only a few months or half a year. If such in vitro reagents are not widely used clinically, they are prone to expire and become invalid. Coupled with the loose management of some medical institutions, expired in vitro diagnostic reagents are used in clinical practice. It is obviously unsafe to use such diagnostic reagents for testing, and it is very likely to lead to clinical misdiagnosis, and then lead to wrong treatment.

4. The cold chain of in vitro diagnostic reagents cannot be guaranteed

Many in vitro diagnostic reagents are biological reagents, and there are strict requirements for their production, transportation and storage. At present, the hardware facilities of cold chain logistics are insufficient, the degree of marketization is low, the transportation cost is high, and the delivery of in vitro diagnostic reagents is scattered and infrequent. At present, there are not many in vitro diagnostic reagents transported by cold chain vehicles. Most in vitro reagents are packaged in foam boxes and ice packs to control the temperature during reagent transportation. This transportation mode cannot fully meet the requirements for cold storage of in vitro diagnostic reagents.