COVID-19 nucleic acid 10 in 1 mixed production test specification

COVID-19 nucleic acid 10 in 1 mixed detection technology specification COVID-19 nucleic acid 10 mixed 1 mixed detection (10-in-1test) technology is collected from 10 of 10 swabs collected in 1 sampling tubes for nucleic acid detection.

  1、 Specification of sample collection consumables (I) the cap and body of virus collection tube shall be made of polypropylene, the spiral port can be sealed, the tightness is moderate, the tube body is transparent and the visibility is good.

The outer diameter of the test tube is (14.8 ± 0.2) mm * (100.5 ± 0.4) mm, the outer diameter of the tube cap is (15.8 ± 0.15) mm, and the height is (12.5 ± 0.5) mm.

Capacity enterprise calibration 10ml, containing 6ml preservation solution of guanidine salt or other effective virus inactivators.

The preservation solution shall have a color that is easy to observe and identify (such as pink), and maintain a certain fluidity for sampling( 2) The sampling swab should be made of polyester, nylon and other non cotton and non calcium alginate materials, and the handle should be made of non wood materials.

The breaking point is about 3cm away from the top of the swab head, which is easy to break.

  2、 It is required to select an open and well ventilated site as the centralized collection site for large-scale population screening.

According to the original site conditions, it is divided into waiting area, collection area, buffer area and temporary isolation area to effectively disperse the density of personnel to be inspected, and first-aid equipment shall be set for standby.

 ( 1) The waiting area shall be provided with pedestrian passage and one meter line to ensure the protection safety of waiting personnel.

Thermal insulation, cooling, sun shading, rain protection and other facilities shall be provided according to the weather conditions.

The elderly, children, pregnant women and others with mobility difficulties are preferred.

 ( 2) According to the climatic conditions, the collection area is equipped with tents, cold / warm fans and appropriate tables and chairs to ensure that the medical staff work in a relatively comfortable environment.

Disinfection supplies, swabs and virus collection tubes for collection shall be provided, and paper towels, vomiting bags and masks shall be prepared for the tested personnel for standby.

If the specimen cannot be transported to the laboratory in time, a 4 ℃ refrigerator or low-temperature storage box shall be prepared for temporary storage.

An emergency plan shall be formulated to prevent the spread and infection of pathogenic microorganisms.

 ( 3) The buffer zone space shall be relatively sealed for the collection personnel to replace personal protective equipment, place protective articles, collection and disinfection articles, swabs and collection tubes matching the scale of the sampling point, and outdoor killing equipment.

 ( 4) The temporary isolation area is used to temporarily isolate suspected patients or high-risk groups found during collection.

3、 Collection process (I) identification and information registration 1.

Registration process.

The staff allocated 10 subjects to the collection before collection, and collected and registered the relevant information of the examiner before collection (including name, gender, ID number, contact telephone, location, date and time), and collected the number of the collection according to the group.


Registration requirements.

It is recommended to use information-based means such as ID card reader and QR code bar code to associate the subject information to improve the efficiency and accuracy of information reading.

If there is no information condition, the registration form of COVID-19 nucleic acid 10 and 1 mixed extraction should be registered in advance (see annex, hereinafter referred to as the mixed registration form).

The paper registration form shall be backed up and archived in the community where the collection point is located before submitting it with the specimen for examination, so as to facilitate the timely tracing of the tested person.

 ( 2) Collection method the head of the collected person is slightly tilted, the mouth is wide open, and the “ah” sound is made to expose the pharyngeal tonsils on both sides.

The collection personnel will pass the swab over the tongue root of the collected person, wipe the pharyngeal tonsils back and forth slightly for at least 3 times, and then wipe up and down the posterior pharyngeal wall for at least 3 times.

After the operation, place the swab head in the tube and the swab breaking point at the mouth of the tube, Break the swab head slightly to make it fall into the liquid of the collection tube, discard the broken swab rod, tighten the tube cover, place the collection tube on a stable shelf, and the collection personnel shall disinfect their hands after each collection.

 ( 3) Mixed swabs collect the remaining 9 swabs in sequence according to the above collection method, and put the collected swabs into the same collection tube with gentle action to avoid aerosol generation.

After collecting 10 swabs continuously, tighten the tube cover to prevent overflow.

If there are less than 10 swabs in the collection tube, special marks shall be made and recorded.

  4、 Sample submission (I) check the information, check the information of the collection tube label and the mixed collection registration form, and ensure that it is accurate, complete and consistent in number.

 ( 2) For specimen placement, put the verified collection tube into a transparent plastic sealed bag (one-layer container), seal the bag mouth, and spray the outside of the sealed bag with 75% ethanol.

Put the sealed bag into a two-layer container (optional packaging box with appropriate moisture absorbing materials or double-layer medical garbage bag), and spray it with 75% ethanol for disinfection after sealing.

Put two layers of containers into special specimen transfer boxes with “biological hazards” identification (recommended transfer boxes that meet the UN2814 standard for transport of class a goods in accordance with the technical regulations for dangerous goods aviation safety), and ice gel bags should be placed between the two layers of containers and transfer boxes.

The secondary container shall be fixed in the transfer box to keep the specimen upright.

After sealing the transfer box, spray 75% ethanol for disinfection, and the surface of the transfer box is clean and pollution-free.

 ( 3) Specimen transfer requirements.

Standard transfer boxes shall be transported by special specimen carriers.

Specimens should be sent to the laboratory within 2-4 hours after collection.

The registration form of mixed collection shall be put into an independent sealed bag and transported together with the transfer box.

If it cannot be submitted for inspection immediately, it shall be equipped with a special refrigerator or refrigerator for storage, and the registration of specimen reception and preservation shall be made.

The specimens can be stored at 4 ℃ within 24 hours after collection.

5、 (I) specimen receipt in the laboratory.

The transportation and receiving personnel shall double sign for the specimen.

The receiving personnel shall check whether the mixed collection registration form is completed, whether the information of the tested person is traceable, and whether the transfer box and secondary container are damaged.

 ( 2) When opening the specimen, open the transfer box in the core area of biosafety secondary laboratory and take out the secondary container.

Open the two-layer container in the biosafety cabinet, spray or wipe with 75% ethanol for disinfection, take out the sealing bag, spray or wipe with 75% ethanol reagent for disinfection, and check whether it is well sealed.

 ( 3) Check whether the label of the collection tube is consistent with the information in the mixed collection registration form.

Take out the collecting tube, check whether the tube wall is damaged and the nozzle leaks, and spray or wipe with 75% ethanol for disinfection after confirming that there is no damage or leakage.

In case of damage and leakage, the operation shall be stopped immediately, covered with absorbent paper, disinfected with 0.55% chlorine disinfectant, and destroyed after unqualified registration.

 ( 4) Specimens that cannot be tested in time shall be stored in a special refrigerator.

Specimens tested within 24 hours can be stored at 4 ℃.

Specimens that cannot be detected within 24 hours shall be stored at – 70 ℃ or below.

If there is no storage condition of – 70 ℃, it shall be temporarily stored at – 20 ℃.

Avoid repeated freezing and thawing of specimens.

Set up a special warehouse or counter to store samples, and manage with two people and two locks.

 ( 5) After the transfer container is removed from the used two-layer container, the inner and outer walls are wiped and disinfected with 75% ethanol and removed from the biosafety cabinet.

After the experiment, ultraviolet lamp is used for irradiation and disinfection.

  6、 Specimen testing and quality control (I) after receiving specimens, the specimen testing laboratory shall conduct testing immediately.

Full shaking elution was carried out before detection, and then nucleic acid extraction and amplification experiments were carried out.

It is recommended to use reagent containing COVID-19 open reading frame 1ab (ORF1ab) and shell protein (N) gene region.

If the nucleic acid extractor is used, the nucleic acid extraction reagent shall be used together with the nucleic acid extractor.

The amplification kit shall be a kit with registration number approved by the State Food and drug administration.

It is recommended to select a detection kit with low detection limit and high sensitivity..