Active Member
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[China]
Address: F12, Xincheng International Mansion A, No. 234 Huapao Ave., Liuyang, Hunan 410300 China
Contact name:Marx Wu
MAGNUS INTERNATIONAL LIMITED |
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Covid-19 Professional Viral Collection Tube Kit with FDA CE
Approved for testing samples
【Kit Features】
which can ensure the biological safety of the sampled person.
【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】
| Number | Composition | 40 Testing Kits/box | 50 Testing Kits/box |
| 1 | Sampling Tube (with 3ml inactivated solution) | 3ml × 40 tubes | 3ml × 50 tubes |
| 2 | Nasal Swab | 40 pcs/box | 50 pcs/box |
| 3 | Manual | 1 test | 1 test |
Package
Each kit includes “a 10ml tube + 3ml VTM liquid (Or Medium) + 1
sampling nasal
swab or oral swab (Pick one of two)”.
| Individual Package | Bulk Package |
| 50 kits/box | 50 kits/box |
| 16 boxes/carton | 20 boxes/carton |
| Box Size : 225*145*165 mm Weight : 0.7 kg | Box Size : 225*145*165 mm Weight : 0.7 kg |
| Carton Size : 600*480*350 mm Weight:12.5 kg | Carton Size : 620*470*350 mm Weight : 14 kg |
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.
【Summary and Principles】
The Disposable Virus Specimen Collection Tube is a collection and transport system suitable
for collection, transport, and long-term freeze storage of clinical virus specimens.
The sampling solution(Viral Transport Medium) comes in a plastic, screwcap10mltube and
used for the transport of clinical specimens from the collection site to the testing laboratory.
The composition of Viral Transport Medium is modified Hank's inactivated buffer, and
using Viral Transport Medium to transport and store the virus will cause viral inactivation.
The Disposable Sampling Swab is composed of Nylon flock and ABS. The flocked swab
contains short perpendicular fiber strands attached to flexible molded plastic. The swab
has a molded breakpoint in the shaft of the applicator which is highlighted with an
indication line marked on the shaft of the applicator. After the sample is collected from
the patient, the molded breakpoint facilitates easy breakage of the swab applicator into
the tube of transport medium. There are two modes of Disposable Sampling Swabs:
Nasal swab and Oropharyngeal swab. Users can choose one of the Nasal swabs and the
Oropharyngeal swab.
【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.
【INDEX OF SYMBOL】
【EXPORTER】
Magnus International Limited
F12, New City International Mansion A, 234 Huapao Ave.
Liuyang, Hunan Province 410300 China
Contact: Goodwellmedical@gmail.com
【MANUFACTURER】
Changsha Renji Medical Equipment Co., Ltd.
No.18 Xiangtai Road, Liuyang Jingkai District,
Changsha City, Hunan Province 410300 China
【AUTHORIZED REPRESENTATIVE】
Lotus NL B.V.
Koningin Julianaplein 10, 1e Verd, 2595AA, The Hague, Netherlands.
【FACTORY VIEW】
【FACTORY WORKSHOP】
【PRODUCT AND STANDARDS】
【CERTIFICATIONS】
【FAQ】
