Covid-19 Professional Viral Collection Tube Kit with FDA CE

Approved for testing samples

【Kit Features】

• FDA Approved
• Swabs and Tubes are sterilized using High Energy Electron Beam Irradiation,

which can ensure the biological safety of the sampled person.

• Lot number located on each kit to allow for full specimen traceability
• Kits can be stored for up to 1 year at room temperature.
• The expiration date on each tube, swab, and kit.
• Biohazard Bags with the absorbent pad are available.
• Samples available to test and verify.
• Bulk packaging is available to save you money.

【Sterilization】

The Virus Specimen Collection Tube and Disposable Sampling Swab are sterile.

【Storage and Stability】

This product is ready for use and no further preparation is necessary. The product should

be stored in its original container at 5-25℃ until used. Do not overheat. Do not incubate or

freeze prior to use. Improper storage will result in a loss of efficacy. Do not use after the

expiration date, which is clearly printed on the outer box and on each individual sterile

collection unit and the specimen transport tube label. The shelf-life of the Disposable Virus

Specimen Collection Tube is 24 months after the manufacture date.

【Precautions】

1. This product is for In Vitro Diagnostic Use.

2. Observe approved biohazard precautions and aseptic techniques. To be used only by

adequately trained and qualified personnel.

3. All specimens and materials used to process them should be considered potentially

infectious and handled in a manner that prevents infection of laboratory personnel.

Sterilize all biohazard waste including specimens, containers, and media after their

use. Reference to other CDC websites and CDC Biosafety Level 2 recommendations

(*Refer to 1, 2, 3, 4, 5).

4. Directions should be read and followed carefully.

【SAMPLE REQUIREMENTS】

1. Swab and Tube are sterilized using High Energy Electron Beam Irradiation, which can

ensure the biological safety of the sampled person.

2. Lot number located on each kit to allow for full specimen traceability Kits can be stored up

to 2 years at room temperature.

3. Expiration date on each tube, swab, and kit Biohazard Bags with the absorbent pad is

available.

4. Samples available to test and verify.

5. Bulk packaging is available to save you money.

Applicable sample types: Oropharyngeal, Nasopharyngeal, Saliva, Sputum, and other clinical

samples. Storage and transportation of samples: After the sample is collected, it should be

transported to the corresponding laboratory for testing within 48 hours, and the storage

temperature is 2-8℃. If it cannot be transported to the laboratory within 48 hours, it should

be stored at -20℃ or below and sent to the corresponding laboratory within one week.

The sample should avoid repeated freezing and thawing

【PACKING】

40Testing Kits/ box & 50Testing Kits/ box

Standard

1nasalswab+10mltube+3ml inactivation/Non-inactivation medium

【INTENDED USE】

It is used for the collection and transportation of clinical COVID-19, Influenza, Avian

Influenza, Hand, Foot and Mouth Disease, Measles, Chlamydia, Mycoplasma, and

Ureaplasma specimens.

【MAIN COMPONMENTS】

Package
Each kit includes “a 10ml tube + 3ml VTM liquid (Or Medium) + 1 sampling nasal

swab or oral swab (Pick one of two)”.

Our disposable virus specimen collection tubes are used for the collection and transportation of

Novel Coronavirus/SARS COV-2, Influenza, Avian Influenza, Hand, Foot and Mouth Disease,

Measles, Chlamydia, Mycoplasma, and Ureaplasma specimens.

【STORAGE CONDITIONS】

Store at temperature 5 - 25 ℃.

【INSTRUCTIONS】

1. Mark the sample information on the tube.

2. According to different sampling requirements, use a sampling swab to sample at the corresponding area.

Hold the handle to gently insert the sampling swab into the sampling site, gently rotate the swab 3-5

times and slowly take out.

3. Put the extracted sample into the sampling tube, break the swab at the breaking point and leave the

swab head in the tube. Tighten the tube cap to complete the sampling.

4. Freshly collected clinical specimens should be transported to the laboratory within 48 hours at 4 ° C.

Those that cannot be sent to the laboratory within 48 hours should be stored at -20 ° C or below.

5. The conventional sampling methods are as follows: Nasal swab: Insert the head of the swab gently

into the nasopalatine part of the nasal canal, stop for a while, and then slowly rotate it out. Repeat to

another nostril with a new swab. Once the specimen is collected, immerse the head of the swab into the

sampling solution, and discard the tail. Oropharyngeal swab: Use a swab to wipe the bilateral

pharyngeal tonsils and posterior pharyngeal wall. Immerse the swab head in the sample solution and

discard the tail. Mouthwash: Gargle in the mouth with 10ml of normal saline. Let the patient's head

tilt back slightly and make an "Oh" sound. Let the saline rotate in the pharynx then collect the wash

with an empty 50ml sampling tube. Nasal wash: While seated, the patient tilts their head slightly back

and is injected with 50 ml of normal saline into one nostril with a pipette. Collector instructs the patient

to simultaneously sound “K” to close the pharyngeal cavity. The patient then bows their head to let the

saline flow out as the fluid is collected with an empty 50 ml sterilized tube. Repeat this process to wash

the other nostril. Nasopharyngeal extract: Tracheal and bronchial secretions are often collected using

this method. Mucus is drawn from the nasopharynx with a collector connected to a negative pressure

pump. First insert the collector head into the nasal cavity, turn on the negative pressure, rotate the

collector's head, and slowly push it out. Collect and draw the mucus, and rinse the collector three times

with 5 ml of the sampling solution. Autopsy tissue specimens: Collect autopsy tissue specimens if

necessary, to separate sample components. The specimen is autopsy tissue. Samples of mycoplasma,

chlamydia, ureaplasma: for males, inserts the sterilized swab into the urethra about 2cm, rotate, and

take out. Let the material rest for several seconds. For females, wipe out the cervical mucus and inserts

the sterilized swab into the cervical canal 1cm-2cm to take out material.

Nasal swab: Insert the head of the swab gently into then a so palatine part of the

nasal canal, stop for a while, and then slowly rotate it out. Repeat to another

nostril with a new swab. Once the specimen is collected, immerse the head of the

swab into the sampling solution, and discard the tail.

Oropharyngeal swab: Use a swab to wipe the bilateral pharyngeal tonsils and

posterior pharyngeal wall. Immerse the swab head in the sample solution and

discard the tail.

【Quality Control】

1. Each lot of media is tested for microbial contamination and toxicity to host cells.

Refer to publications by ASM(6, 7, 8) and CLSI(9, 10).

2. The sterility test of the Viral Transport Medium and Disposable Sampling Swab is

cultured using sugar blood agar(SBA) and tryptic soy agar(TSA) medium. After 3

days of culture, there should be no microbial growth.

【Performance Characteristics】

Take the commercial avian influenza vaccine as the positive sample, sterile water

as the negative sample, use the Disposable Virus Specimen Collection Tube to

sample, and use the fluorescent quantitative PCR method to detect. If the test result

of the positive sample is positive and the negative sample is negative, the Disposable

Virus Specimen Collection Tube is qualified.

【Results】

Results obtained will largely depend on proper and adequate specimen collection,

as well as timely transport and processing in the laboratory.

【WARNING】

1. Unused swabs should not be re-sterilized.
2. This product is for single use only； reuse may cause a risk of infection and/or

inaccurate results.
3. Do not re-pack.
4. Not suitable for any other application than intended use.
5. Do not ingest the medium.
6. To be handled by trained personnel only.
7. It must be assumed that all specimens contain infectious micro-organisms；

therefore, all specimens must be handled with appropriate precautions.
8. After use, tubes, and swabs must be disposed of according to laboratory regulations

for infectious waste. Observe CDC Biosafety Level 2 recommendations.
9. The composition of Renji VTM is modified Hank's inactivated buffer and using

Renji VTM to transport and store the virus will cause viral inactivation.

【FACTORY VIEW】

【FACTORY WORKSHOP】

【PRODUCT AND STANDARDS】

【CERTIFICATIONS】

【FAQ】

1. Q: How about your healthcare and medical product quality?

A: Quality is our top priority. We have a professional quality control team to ensure the

quality with a high standard and regulated with the pro certifications. The QC team is

responsible for quality checking in each process and inspect every batch of our production

and ship them only after QC approval.

2. Q: What is your order MOQ?

A: Please contact the customer service, and the price is negotiable for large quantity.

3. Q: How about your product packing for shipment or mailing?

A: We prepared well neutral package for our products. We could also make OEM package,

OEM/ODM Custom Package/Multi-packing package/Cartons with well protective wrapping.

4. Q: What level of your product price?

A: We are the factory and direct manufacturer and offer competitive prices. We also offer

the volume pricing with more benefits depend on your order quantity level. Please let us know

your ordering volume while you make the inquiry to us to help you obtaining better benefits.

5. Q: What's the price terms?

A: The price is based on FOB of Hunan, China with exchange rate at RMB6.40 for USD$1.00.

If the exchange rate floating sharply lower than 6.3 or higher than 6.5, we should adjust the

price with real-time exchange rate.

6. Q: What's the payment terms?

A: We accept T/T wire transferring, PayPal, Western Union, etc. 50% down payment after

signing the contract and rest 50% before shipping confirmation.

7. Q: How could I get some samples?

A: We are able to deduct your samples expense once your orders confirmed with us.

The shipping fee will be calculated with the sample volume what you demand.

8. Q: Could you accept OEM order?

A: Yes, we could. We have professional designers who can design the logo or artwork and offer

best solution & styles for your OEM product choices.

9. Q: How long will the shipping or express take?

A: (1) For the international expresses such as DHL, UPS, FedEx, TNT, or EMS, etc., it usually

takes 5-7 working days to your location or destination.

(2) If shipping with containers, they will take about 30-60 days to process depending on

the vary ports or door locations.

(3) We will arrange your products delivery or shipping within 1-3 days after full payment

has been confirmed. We may not ship your products out until your payments arrive to

our bank account successfully.

10. Q: How do you deliver the goods to us?

A: If the order of small volume package, we could deliver by courier such as DHL, UPS, FedEx,

TNT, EMS. For the large volume order, we could ship with bulk cargo containers by sea.

We will provide you cost-saving recommendations for your product shipping.

11. Q: What is the warranty time.

A: One year f each product.

【SHIPPING】

We are the trusted healthcare and medical supplies from China.

Be free to contact us at any time!

You are very welcome to email us today at:

Goodwellmedical@gmail.com for the inquiry!

We are excited to build a reliable and long-term business with you

at our best!

Magnus International Limited-Goodwell Medical is an international exporter and distributor based in Hong Kong with factories located in Hunan and Jiangxi China. Since 2013, Magnus International Limited has exported thousands of containers shipping to the USA and some other countries mainly on Fireworks and Firecrackers, medical materials, and equipment.

We supply high-quality and high-value products for our customers with professional service for years. We support our customers with reliable quality and reputational consistent products to bring greater value and high profits.

We have Magnus Fireworks brand, a well-known and respectful brand selling popular in the United States of America for over 8 years.

We invested in Renji Medical of China DBA Goodwell medical and make research and development on Covid-19 Epidemic prevention materials and antigen rapid test kits, Nucleic Acid Detection test kits, Collection tubes, Automatic Sample Preparation Systems, etc. In 2021, we invented a rapid Antigen detection kit with a high speed of fewer than 15 minutes for results!

We are looking forward to supporting your business with a long-term trustworthy relationship to bring good quality healthcare and medical products to more people to help them prevent and fight the covid-19 virus.

For inquiry today: goodwellmedical@gmail.com

Whatsapp: +86 135 0741 5915