Disposable virus sampling kit 

Instruction for Use

【Product Name】

Disposable virus sampling kit

【Packing Specifications】

A1\A2

【Intended Use】

This product is mainly used for collection, transportation and preservation of oropharyngeal parts of respiratory and enteric virus such as new coronavirus (COVID-19), influenza, bird flu, hand-foot-mouth, swine flu and so on. It is also suitable for the collection of other viruses, chlamydia, mycoplasma and ureaplasma urealyticum specimen.

The collected samples are stored in the sample preservation solution, which can be used for the extraction and purification of viral DNA/RNA for subsequent RT-PCR analysis or gene sequencing and other detections.

【Main Components】

Sample storage tube

The tube body and tube cover are made by polypropylene.

Sample preservation solution

Light red Hank‘s solution is non-inactivated solution contains antibiotics that can effectively inhibit the reproduction of bacteria and fungi.

Colorless and transparent preservative solution is inactivated solution which can effectively inactivate virus and reduce the degradation of viral nucleic acid.

Built-in glass beads, convenient elution, conducive to the release of viruses and other microorganisms into the sample preservation solution.

Sampling swab

The sampling swab is made by synthetic fiber flocking, and the swab handle with unique design of molded breakpoint.

【Testing Procedure】

1.Tear off the package.

2.Take out the flocked swab, and collect samples from right body parts based on sampling requirement.

3.Place the test swab into the sample storage tube immediately.

4.Break the swab handle at the marked breakpoint.

5.Immerse the swab head fully in the sample preservation solution, and tighten the tube cover.

6.Mark the information on the label as required.

Remark：Freshly collected samples should be delivered to the laboratory within 48 hours; if it can’t be delivered to the laboratory within 48 hours, it should be stored at room temperature (2-35℃) for 7 days; if long-term storage is required, it should be stored at -40 ~ -70℃ (stable storage time and conditions, should be verified by each laboratory according to the final experimental purpose). Repeated freeze-thaw should be avoided.

【Storage conditions and validity】

Store at 5～25℃ to avoid direct exposure to sunlight and it is valid for 12 months.

【Precautions】

1. The sample preservation solution must not be touched by any person.

2. Sampling swabs must not be placed in the sample preservation solution before use.

3. Do not use if the tube body is damaged or the tube cap leaks liquid and and out of validity.

4. Do not use if the sample preservation solution is turbid, discolored and dried.

5. This product is only for one-time use and only used for storage after sample collection and during in vitro transportation.

6. Read the operation manual carefully before use and operate as required.

7. Wear clean protective gloves and masks during operation; if necessary, wear protective clothing such as isolation clothing, protective masks and goggles, etc.

8. After use, the waste shall be disposed according to the regulations of the hospital or the environmental protection department.

9. Freshly collected samples should be delivered to the laboratory within 48 hours.; if it can’t be delivered to the laboratory within 48 hours, it should be stored at room temperature (2-35℃) for 7 days; if long-term storage is required, it should be stored at -40 ~ -70℃ (stable storage time and conditions, should be verified by each laboratory according to the final experimental purpose). Repeated freeze-thaw should be avoided.

Instructions For Use

1. Product Name

Nucleic Acid Extraction Kit

2. Model

25T/Kit,50T/Kit

3. Intended Use

For the extraction and purification of nucleic acids (DNA/RNA) from samples such as plasma, serum, ascites, supernatant of tissue grinding, supernatant of cultured cells, cerebrospinal fluid, etc. The purified nucleic acids can be used for clinical in vitro testing.

4. The Principle

This product can extract high quality DNA/RNA from different samples using magnetic bead and buffer system with unique separation function. Based on superparamagnetism, magnetic beads can isolate and purify DNA/RNA under the action of adsorption, transfer and release of buffer system and magnetic bar. The purified nucleic acids can be used for PCR, RT-PCR, real-time quantitative PCR and other downstream experiments.

5. Kit Components

Lysis buffer, Wash buffer, Magnetic suspension, Eluent.

6. Storage Conditions and Period of Validity

6.1 Storage: All reagents can be stored at room temperature (3-25℃).

6.2 Period of Validity: 12 months. The pre-packed plate shall be used within 12 hours after unpacking, please use within the validity period.

7. Applicable Instruments

Conventional centrifuge, Dry bath or Thermostatic water bath, Vortex oscillator.

8. Sample Requirements

8.1 Applicable Sample Type: plasma, serum, ascites, supernatant of tissue grinding, supernatant of cultured cells, cerebrospinal fluid, semen, milk, urine, exfoliate cell suspension, etc.

8.2 Sample Collection:All samples were collected in accordance with the requirements for clinical testing issued by the National Health Commission and its authorities.

8.3 Sample Preservation:The collected samples should be immediately extracted for nucleic acid. If cannot be detected in time, it should be stored at 2~8℃,and the storage time should not exceed 24 hours; Samples can be stored at -70℃ and barely at -20±5℃ for a long time (≤ one year). Samples should avoid repeated freeze-thaw cycles.

8.4 Sample Transport: Samples shall be transported in accordance with relevant specifications such as“Regulations governing the transport of highly pathogenic microbial strains (viruses) or samples capable of infecting humans”, and“Regulations on biosafety management of pathogenic microorganism laboratory”.Samples should be transported at 2~8℃.

9. Test Methods

9.1 Pre-experiment Preparation

9.1.1 Take out the pre-packed 96-well deep-hole plate, shake the plate lightly, and make the reagent and magnetic beads concentrate on the bottom of the plate (or instantaneous centrifugation using an orifice centrifuge). Tear off the sealing film carefully before use, and avoid the vibration of the orifice plate to prevent the liquid from spilling out.

9.1.2 The distribution of reagents in the pre-packed 96-well deep-hole plate is shown in the table below:

Notes: 1. Do not mix different batches of reagents. Please use the kit within the validity period.

2. Self-prepared materials: RNase- and DNase-free EP tubes and pipette tips.

3. Type I using the type “V” 96-well plate, and type II using the type “U” 96-well plate.

9.2 Extraction Steps

9.2.1 Sample

Adding the samples (200μL) into the hole H1 or H7 of the pre-packed plate. If internal standards monitoring the nucleic acid extraction process are needed, add it at this step (≤20 μL).

9.2.2 Instrument Extraction Procedure

Put the50-well deep hole plate and the stirring sleeve into the specified position of the instrument. The following procedure is recommended for extraction experiments:

I. Setting parameters of 96 magnetic bar sleeve instruments including Kingfisher flex:

II. Setting parameters of 16 magnetic bar sleeve instrument including Tianlong and Bori:

9.2.3 Product Preservation

When the process is over, remove the stirring sleeve and discard it, transfer liquid (nucleic acid sample) from 96-well deep hole plate 6/12 colume to new EP tube. If the downstream test cannot be carried out in time, DNA are stored at -20 ± 5℃ and RNA are stored at ≤ -70℃.

10. Reference Range

OD260/OD280 ratio: 1.6~2.0.

11. The Limitations

11.1 The product is suitable for body fluid samples. Excessively high content of solid substances in samples may affect the quality of nucleic acid extracted.

11.2 Reliable results depend on the quality of multiple processes including sample collection, transport, storage and handing.

12. Performance Index

12.1 Outlook

12.1.1 Package: Complete package, no leakage of reagent.

12.1.2 Label: The label is complete and does not fall off. The label identification content is clear and correct.

12.1.3 Outlook: The liquid reagent should be clear and transparent, free of turbid or visible lumpy insoluble matter.

12.2 Purity of Nucleic acid Extraction

Requirement:OD260/OD280: 1.6-2.0.

12.3 The pH of Lysis Buffer:7-7.6

13. Warnings

13.1 The kit are for in vitro diagnosis and professional only.

13.2 Operators should be professionally trained and have certain experience and operating skills; wear masks, disposable latex gloves (often replaced) and other protective measures, use disposable RNase/DNase-free EP tube, TIP head and self-discharging pipettor.

13.3 Operate strictly according to the instructions and the testing procedures of the biosafety laboratory of infectious diseases.

13.4 Avoid cross-contamination between samples during sample collection and storage process; the use of biosafety cabinets in the sample processing stage is recommended.

13.5 The biosafety cabinets, pipettes and centrifuges used in the operation should be disinfected with 75% alcohol before and after the experiment, and the workbench is irradiated with ultraviolet light for more than 30 minutes.  

13.6 The pre-dispensing plate contains irritant compounds, if accidentally contaminated the skin and eyes, immediately wash with plenty of water or normal saline, and seek medical consultation if necessary.

13.7 The laboratory management should be strictly in accordance with the relevant national management standards for molecular biology laboratories and clinical gene amplification laboratories.   

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