New coronavirus nucleic acid 20-in-1 mixed detection technical specifications released

Recently, the Medical Rescue Team of the Joint Prevention and Control Mechanism of the State Council issued the "Technical Specifications for 20-in-1 Mixed Collection and Detection of New Coronavirus Nucleic Acids"
.
The "Specification" pointed out that the 20-in-1 mixed detection technology (referring to the method of collecting 20 swabs collected from 20 people in one collection tube for nucleic acid detection) can greatly improve the detection efficiency and is more suitable for large-scale populations.

Notice on Issuing the Technical Specification for 20-in-1 Mixed Mining Detection of Novel Coronavirus Nucleic Acids

Joint Prevention and Control Mechanism Medical Issue [2022] No.
21

All provinces, autonomous regions, municipalities directly under the Central Government and the Xinjiang Production and Construction Corps shall respond to the joint prevention and control mechanism of the new crown pneumonia epidemic (leading group, headquarters):

In order to guide all localities to do a good job in the mixed collection and detection of the new coronavirus, further improve the nucleic acid detection capacity and efficiency, and implement the "four early" requirements, on the basis of the current 10-in-1 mixed collection of new coronavirus nucleic acid, we have organized and formulated the "New Coronavirus Nucleic Acid 20".
Combined 1 Mixed Mining Detection Technical Specifications
.
It is hereby printed and distributed to you for your reference

State Council Responds to Novel Coronavirus Pneumonia

Joint Prevention and Control Mechanism Medical Rescue Team

(on behalf of the chapter)

January 15, 2022

(form of information disclosure: active disclosure)

Copy to: Health and Health Committees of all provinces, autonomous regions, municipalities directly under the Central Government and Xinjiang Production and Construction Corps
.

New coronavirus nucleic acid 20-in-1 mixed detection technical specification

In order to guide various localities to carry out the new coronavirus mixed collection detection work and further improve the nucleic acid detection capability and efficiency, on the basis of the existing 10-in-1 mixed collection detection technology, the new coronavirus nucleic acid 20-in-1 mixed collection detection (20-in-1 test ) technology (referring to the method of collecting 20 swabs collected from 20 people in one collection tube for nucleic acid detection), to formulate this specification
.

1.
Specimen collection consumables

(1) Virus collection tube
.
The cap and body should be made of polypropylene, with a sealable screw opening and moderate tightness

(2) Collect swabs
.
Swabs made of non-cotton and non-calcium alginate materials such as polyester and nylon should be used, and the handle should be made of non-wood materials

2.
Collection location requirements

Choose an open and well-ventilated site as a centralized collection site for large-scale population screening
.
According to the original site conditions, it is divided into a waiting area, a collection area, a buffer area and a temporary isolation area to effectively disperse the density of people to be inspected

(1) Waiting area
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Pedestrian passages are set up, and a one-meter line is set up to ensure the protection and safety of waiting staff

(2) Collection area
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According to the climatic conditions, it is equipped with tents, cooling/heating fans, appropriate tables and chairs to ensure that medical staff work in a relatively comfortable environment

(3) Buffer
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The space should be relatively airtight, allowing the collection personnel to replace personal protective equipment, and place protective equipment that matches the size of the sampling site, disinfection supplies for collection, swabs and collection tubes, and outdoor sterilization equipment

(4) Temporary isolation area
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Used to temporarily isolate suspected patients or high-risk groups found during collection
.

3.
Collection process

(1) Identification and information registration
.

1.
Registration process
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The staff assigns 20 subjects to a group before collection, collects and registers relevant information of the subjects (including name, gender, ID number, contact number, collection location, collection date and time) before collection, according to the group Carry out the collection tube numbering
.
Due to the relatively large number of 20 people, in order to avoid confusion among different groups of people, a 2-meter line can be used to strictly separate the next group of waiting people from the group being collected.
Group personnel can enter the sampling area in an orderly manner
.

2.
Registration requirements
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It is recommended to use information means such as ID card readers and QR code barcodes to correlate the subject's information to improve the efficiency and accuracy of information reading
.

(2) Collection method
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The head of the person being collected is slightly tilted, the mouth is wide open, and an "ah" sound is made, exposing the pharyngeal tonsils on both sides.
Wipe the back wall up and down at least 3 times
.
After the operation, put the swab head into the tube, place the swab breaking point at the mouth of the tube, and break it with a little force so that the swab head falls into the liquid in the collection tube, discard the broken swab rod, and tighten the tube.
cover and place the collection tube on a stable rack
.
After the collection of each case, the collection personnel should disinfect their hands
.

(3) Mixed swabs
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The remaining 19 swabs were collected in sequence according to the above collection method, and the collected swabs were placed in the same collection tube with gentle movements to avoid the generation of aerosols
.
After collecting 20 swabs in a row, tighten the cap to prevent spillage
.
Note that the throat swab needs to be immersed in the preservation solution
.
If there are less than 20 swabs in the collection tube, special marks should be made and recorded
.

4.
Specimen inspection

(1) Check the information
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Check the label of the collection tube and the information on the mixed collection registration form to ensure that it is accurate and complete, and the numbering is consistent
.

(2) Specimen placement requirements
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Put the checked collection tube into a transparent plastic sealed bag (one-layer container) and seal the bag tightly, and spray the outside of the sealed bag with 75% ethanol
.
Put the sealed bag into a two-layer container (optional packaging box with an appropriate amount of hygroscopic material or double-layer medical garbage bag), and spray with 75% ethanol for disinfection after sealing
.
Put the second-layer container into a special specimen transfer box with a "biohazard" label (it is recommended to use a transfer box that meets the UN2814 standard for transporting Class A items in the "Technical Rules for the Safe Transport of Dangerous Goods by Air").
Place a cooling gel ice pack
.
The secondary container should be secured in the transfer box to keep the specimen upright
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After sealing the transfer box, spray and disinfect with 75% ethanol, and the surface of the transfer box is clean and free from pollution
.

(3) Specimen transfer requirements
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Standard transfer boxes should be transported by specialized specimen transporters
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Specimens should be sent to the laboratory within 2-4 hours of collection
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If it cannot be sent for inspection immediately, a special refrigerator or freezer should be provided for preservation, and the specimen reception and preservation registration should be done
.
Specimens can be stored at 4°C within 24 hours after collection
.

5.
Laboratory acceptance

(1) Specimen receipt
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Shipping and receiving personnel should double sign for specimens
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The receiving personnel check whether the transfer box and the second-layer container are damaged
.

(2) The specimen is opened
.
The transfer box should be opened in the core area of ​​the biosafety secondary laboratory, and the secondary container should be taken out
.
Open the two-layer container in the biological safety cabinet, spray or wipe with 75% ethanol for disinfection, take out the sealed bag, spray or wipe with 75% ethanol reagent for disinfection, and check whether the seal is intact
.

(3) Examination of specimens
.
Take out the collection tube and check whether the tube wall is damaged or leaking at the nozzle.
After confirming that there is no damage or leakage, spray or wipe with 75% ethanol for disinfection
.
If there is any damage or leakage, the operation should be stopped immediately, covered with absorbent paper, and then disinfected with 0.
55% chlorine-containing disinfectant, and the unqualified registration should be completed before destruction
.

(4) Preservation of specimens
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Specimens that cannot be detected in time should be stored in a special refrigerator
.
Specimens tested within 24 hours can be stored at 4°C
.
Specimens that cannot be detected within 24 hours should be stored at -70°C or below
.
If there is no -70°C storage condition, it will be temporarily stored at -20°C
.
Avoid repeated freezing and thawing of specimens
.
Set up a special library or counter to preserve specimens, and manage with double locks
.

(5) The transfer container is removed
.
After use, the inner and outer walls of the two-layer container were wiped and disinfected with 75% ethanol, and then removed from the biological safety cabinet.
After the experiment, they were disinfected by ultraviolet light irradiation
.

6.
Specimen testing and quality control

Follow the relevant requirements of the "Medical Institutions New Coronavirus Nucleic Acid Detection Work Manual (Trial Second Edition)"
.

7.
Processing of test results

The new coronavirus nucleic acid qualitative test report should include test results (detected/positive, undetected/negative), methodology, detection limit,
etc.

(1) Judgment of results
.
According to the instructions of the amplification reagent used, the test result is judged as undetected/negative or detected/positive
.

(2) Review of positive results
.

1.
If the mixed collection test result is positive, gray area or single target is positive, notify the relevant department to temporarily isolate the 20 subjects in the mixed collection tube, and re-collect a single-tube swab for review
.

2.
If the single-tube nucleic acid test is negative, it will be reported according to the negative result
.
Temporary isolation personnel are released from isolation; if the test results are positive, they will be reported according to procedures
.

8.
Post-test sample processing

The specimen processing after testing shall be carried out in accordance with the relevant requirements of the "Guidelines for the Implementation of New Coronavirus Nucleic Acid Testing Organizations for All Staff (Second Edition)"
.

9.
Basic requirements for technical personnel

The requirements for sampling personnel and testing personnel should meet the requirements of the "Work Manual for Novel Coronavirus Nucleic Acid Detection in Medical Institutions (Trial Version 2)"
.

10.
Biosafety protection

The protection of specimen collection and transportation personnel and laboratory staff shall be carried out in accordance with the relevant requirements of the "New Coronavirus Pneumonia Prevention and Control Plan (Eighth Edition)"
.