Basic requirements and procedures for detection of new coronavirus antigen

Basic requirements and procedures for detection of new coronavirus antigen in primary medical and health institutions

1、 Basic requirements for technicians

（1） Sampling personnel. Technicians engaged in the collection of samples for detection of new coronavirus antigen (hereinafter referred to as antigen) shall pass the biosafety training, be familiar with the types and collection methods of samples, master the operation procedures and precautions for collection of samples, and keep records of sample information to ensure that the quantity of samples meets the requirements and that the samples and relevant information are traceable.

（2） Inspectors. Testing technicians shall have relevant qualifications, and the number of personnel shall be appropriate to the testing items and sample size to ensure timely and skillful experiment and report results, and ensure the accuracy of results.

2、 Basic requirements for specimen collection (I) Basic principles.

1. The detection capacity of primary medical and health institutions should match the number of outpatient and emergency visits, inpatients and other medical treatments, to avoid problems such as overstock of samples, failure of samples, and slow feedback of detection results caused by the obvious excess of collection capacity.

2. When collecting samples, grassroots medical and health institutions should set up different sampling areas according to different collection objects, and sample fever patients and other people in different areas to avoid possible cross infection.

（2） Sample point settings. The establishment of antigen sampling sites by grass-roots medical and health institutions shall follow the principles of safety, science and convenience. The sampling point should be an independent space with ventilation conditions, and the interior should be divided into corresponding clean areas and contaminated areas, equipped with hand hygiene facilities or devices. Clear guidance signs shall be set up at the sampling points, and the sampling process and precautions shall be specified. Set up independent waiting area to ensure one-way flow of personnel as much as possible, implement the requirements of "1m line" spacing, and strictly control personnel density.

（3） Personnel allocation and protection requirements. Each sampling point shall be equipped with 1-2 sampling personnel. Reasonably arrange the sampling personnel to take turns, and in principle, take a rest every 2-4 hours. The sampling personnel shall wear the same protective equipment as that for nucleic acid detection and sampling with the new crown. They shall wear double latex gloves. If the gloves are contaminated, they shall replace the outer latex gloves in time. Each person should strictly disinfect their hands or replace gloves.

（4） Sampling process. Grass roots medical and health institutions shall establish an operational process system for antigen testing sampling, and determine the specific sampling process according to the type of sampling objects, including appointment, payment, information verification, sampling, submission for testing, report distribution, etc. Information of the examinee shall be collected by means of barcode scanning and other information-based means. Before sample collection, the sampling personnel shall check the identity information of the examinee, and inform the time limit and method of issuance of the test report in the form of information announcement in the public area. Each specimen shall record at least the following information:

1. Name, ID card number, residential address and contact information of the subject (patient);

2. Name of sampling unit, sample number, date, time, location, type and quantity of sample collection.

（5） Acquisition method. Select the sample type according to the reagent instructions.

1. Nasopharynx swab. The sampler gently holds the head of the person to be collected with one hand, and holds a swab in the other hand to stick it to the nostril to enter. The sampler slowly penetrates back along the bottom of the lower nasal meatus. Since the nasal meatus is curved, it is not allowed to exert too much force to avoid traumatic bleeding. When the top of the swab reaches the back wall of the nasopharynx cavity, gently rotate it for a circle (stay for a moment in case of reflex cough), then slowly take out the swab, and immerse the swab head into the sampling container with preservation solution matching the test strip.