In vitro diagnostic reagent science knowledge answer (IV)

31. How does China manage the operation of in vitro diagnostic reagent products?

Answer: According to the requirements of my country's current "Medical Device Operation Supervision and Management Measures", the operation of in vitro diagnostic reagents is classified and managed according to the risk level of in vitro diagnostic reagents.

The operation of the first type of in vitro diagnostic reagents does not require licensing and filing, the operation of the second type of in vitro diagnostic reagents is subject to filing management, and the operation of the third type of in vitro diagnostic reagents is subject to licensing management.

Engaged in the second and third types of medical device business, the operating enterprise shall file or file an application for license with the municipal food and drug supervision and administration department where the district is located, and obtain the medical device business record certificate or medical device business license before operating.

32. What are the conditions for operating in vitro diagnostic reagents?

Answer: To engage in the business of in vitro diagnostic reagents, the following conditions should be met:

The (I) shall have a quality management organization or quality management personnel suitable for its business scope and scale, and the quality management personnel shall have relevant professional education or professional titles recognized by the state;

The (II) has a place of operation and storage commensurate with its business scope and scale;

(III) have storage conditions suitable for the scope and scale of business, and if all medical devices are entrusted to other medical device business enterprises for storage, no warehouse may be set up;

The (IV) has a quality management system that is compatible with the in vitro diagnostic reagents it operates;

The (V) has the ability of professional guidance, technical training and after-sales service suitable for the operation of in vitro diagnostic reagents, or agrees to provide technical support by relevant institutions.

Enterprises engaged in the operation of Class III in vitro diagnostic reagents shall also have a computer information management system that meets the quality management requirements of medical device operations to ensure that the products they operate can be traced back.

33. What are the requirements for sales personnel of in vitro diagnostic reagents?

Answer: The in vitro diagnostic reagent business enterprise shall bear legal responsibility for the purchase and sale of in vitro diagnostic reagents engaged in by its office or sales personnel in the name of the enterprise.

An in vitro diagnostic reagent business enterprise shall not operate in vitro diagnostic reagents that have not been registered or filed, have no qualified certification documents, and are expired, invalid, or eliminated.

Sales personnel of in vitro diagnostic reagents operating enterprises shall provide a power of attorney stamped with the official seal of the enterprise to sell in vitro diagnostic reagents. The power of attorney shall specify the variety, region and duration of the authorized sale, and indicate the ID number of the salesperson.

34. What are the legal requirements for online sales of in vitro diagnostic reagent products?

Answer: Online sales of in vitro diagnostic reagents should comply with the "Internet Drug Information Service Management Measures."

When consumers buy in vitro diagnostic reagent products online, they should check the qualification certificate of Internet drug information service and the qualification certificate of Internet drug trading service, and check the qualification certificate number of Internet drug trading service institutions Home.

35. What are the regular ways to purchase in vitro diagnostic reagents?

Answer: The operation of in vitro diagnostic reagents should follow China's current "Medical Device Operation Supervision and Management Measures."

No unit or individual may forge, alter, buy, sell, lease, or lend medical device business licenses and medical device business record certificates.

To purchase the second and third types of in vitro diagnostic reagents, you need to check whether the business unit has a medical device business record certificate or a medical device business license. Do not purchase Class II and Class III in vitro diagnostic reagents from units that do not have the qualifications for medical device business.

When purchasing in vitro diagnostic reagents, you should check whether there is a filing certificate or registration number on the instructions and labels of the purchased products. If you have any questions about the filing certificate or registration number, you can log on to the official website of the municipal food and drug regulatory authority or the official website of the State Food and Drug Administration where the manufacturer is located.

36. How to protect rights after purchasing unqualified in vitro diagnostic reagents?

Answer: It is found that the purchased in vitro diagnostic reagent product is unqualified or counterfeit. It is recommended to do two things in time to protect your rights:

First, the rights. You should keep the product and purchase invoice until your rights are maintained. If you use the product and cause damage to the facts and consequences, you should also keep relevant evidence, such as medical records, invoices, disability reports, etc. Of course, it is best to have an appraisal report on the use of the product and the damage caused.

Rights protection can be carried out from two aspects, one is from the perspective of consumer rights protection, and the other is from the perspective of damage compensation. The choice of which method to proceed depends on whether it is conducive to safeguarding rights and whether it is convenient. Generally speaking, if you buy unqualified or counterfeit in vitro diagnostic reagents and do not use them, or use them without causing harm, you can directly seek compensation from the merchant and seek the help of the local "consumer association". This method is more convenient. If you buy and use the product and cause harm, the "Consumer Rights Protection Law" is not enough to protect your rights. At this time, you should choose the way of litigation and use damages to protect your rights more vigorously.

Second, complain to the local food and drug regulatory department and the administrative department for industry and commerce, and let the functional departments investigate and deal with it, so as to maintain the order of the medical device market.

37. How do I report a complaint after discovering a suspected violation of the law?

Answer: if consumers find suspected violations of laws and regulations or product quality problems such as operating products without registration number or product filing certificate, using products beyond the validity period, using fake registration (or fake filing) certificates, fraudulently using product registration (or filing) certificates of other enterprises, they can report complaints to the food and drug supervision and administration departments at or above the county level or call "12331" for complaint reporting.

38. What does it mean that the indicators in the laboratory report exceed the "reference value?

Answer: After going to the hospital for laboratory tests, when you get the laboratory report, you will find that the indicators on the list are listed as "reference values". The reference value is a value used for reference and guiding judgment. It actually refers to the average value of the vast majority of people in the normal population, which is statistically significant.

The test results are affected by many factors. When the result value of a certain test index exceeds the reference value, it should be handed over to the doctor as soon as possible in combination with symptoms, signs, other auxiliary examinations and other comprehensive analysis to make a correct diagnosis.

Attention should be paid to the situation that the test results are not within the "reference value" range, but there is no need to be too nervous. It is a good policy to consult a doctor as soon as possible.

39. What are the main forms of in vitro diagnostic reagent test results?

A: At present, in vitro diagnostic reagents are used for testing and testing, and the results are reported in three main forms:

One is qualitative testing: the result is either "negative" or "positive". For example, if the test shows that HBsAg is positive, it means that there is hepatitis B virus in the patient.

The second is semi-quantitative detection: mainly to detect the titer, often used for antibody determination, such as anti-nuclear antibody 1:16, etc., belongs to a semi-quantitative report form.

The third is quantitative testing: using specific numerical reports (also the most frequent method on the current test report). Look at the report of the test results with numerical report, be sure to pay attention to the unit of measurement behind the project, the unit of measurement is different, the data obtained is also different, sometimes thousands of times.

When judging the trend of the test results of an indicator, do not just look at the numbers, but pay attention to the units, and the results are comparable only if the units of measurement are the same.

40. What are the main interfering substances that affect the qualitative detection of in vitro diagnostic reagents?

Answer: In vitro diagnostic reagents (kits) for qualitative testing only give positive or negative (reactive or non-reactive, yes or no, with or without, normal or abnormal) two possible results, such as early pregnancy test strips.

Interfering substances can be either endogenous, I .e., derived from the patient's own substances, or exogenous, I .e., substances introduced during the patient's treatment, ingestion, or sample preparation for analysis. Interfering substances can affect the analytical process in many ways (e. g. chemical and physical effects, non-specificity, cross-reactivity, etc.), resulting in interference during analysis and affecting the results of qualitative testing of in vitro diagnostic reagents (kits):

a. Metabolites produced by pathological conditions, such as diabetes, multiple myeloma, cholestatic hepatitis, etc.

B. Compounds introduced in therapy, such as drugs (e. g., vitamin C), parenteral nutrition, plasma expanders, anticoagulants, etc.

c. Substances ingested by the patient, such as alcohol, drugs of abuse, nutritional supplements, various foods and beverages, etc.

d. Substances added during sample preparation, such as anticoagulants, preservatives, stabilizers, etc.

e. Contaminants inadvertently introduced during sample handling, such as from hand cream, powdered gloves, serum separator, collection tube plug, etc.

f. The sample matrix itself, such as chemical and physical properties, is different from the ideal fresh sample.