COLLECTION, TRANSPORT & PRESERVATION SYSTEM
Since its establishment in 2008, WIZCHEM CO., LTD. has been researching, developing, and producing products with global competitiveness to meet customer needs in various fields such as functional chemical materials, biomedical cosmetics, hydrogel wound dressing and medical care. Based on these accumulated technology, for testing various viruses such as coronavirus, we have recently developed and produced in vitro diagnostic products such as viral transport medium(VTM) and swabs that collect and transport infectious virus samples, also viral DNA/RNA extraction kit and saliva collection kit for rapid and accurate diagnosis of diseases.
WIZCHEM’s Clinical Viral Transport Medium (VTM) allows the safe transfer of viruses, chlamydia and mycoplasma for further research, including diagnostic tests, molecular biology techniques and conventional cell culture methods. We are following the WHO and CDC recommendations with swab.
WIZCHEM Viral Transport Medium is intended for the collection and transport of clinical specimens containing Virus, Chlamydia, Mycoplasma and Ureaplasma from the collection site.
The test procedures for quality control are based upon the quality control methods described in CLSI M40-A2 and others. VTM transport Medium is stable for 12 months at 5~25°C. Specimens in VTM medium are stable for 48 hours at room temperature.
This VTM collection and transport system is certified as Biopsy Procedure Kit, class l with product-license number by the Korean FDA.
Transport medium for sample collection and nucleic acid preservation for molecular diagnosis
-. All viruses(COVID-19, Respiratory Syncytial Virus, Influenza A and B, Herpes Simplex I and II, Cytomegalovirus, Echovirus, etc.)
-. Chlamydia tachomatis and pneumoniae
-. Mycoplasma hominis and pneumonia
-. Ureaplasma urealyticum
-. Enzyme Immuno Assays (EIA)
1) VTM medium transport specimens in safety by using self-standing conical Tube.
2) There are two types of swab applicators for the sample collection.
3) Specimens in VTM are stable for 48 hours at room temperature.
4) These products are medical devices certified as class I by the Korean FDA.
|
Component |
Volume |
Cat. No. |
Product Image(Swab Applicator) |
|---|---|---|---|
|
12ml Screw Cap Tube Nucleic acid Preservation Medium Nasopharyngeal Swab Applicator (NSA-T1) |
1ml 2ml 3ml |
VTM 1M-NSA-T1 VTM 2M-NSA-T1 VTM 3M-NSA-T1 |
|
|
12ml Screw Cap Tube Nucleic acid Preservation Medium Oropharyngeal Swab Applicator (OSA-T1) |
1ml 2ml 3ml |
VTM 1M-OSA-T1 VTM 2M-OSA-T1 VTM 3M-OSA-T1 |
|
|
12ml Screw Cap Tube Nucleic acid Preservation Medium Oropharyngeal Swab Applicator (OSA-T2) |
1ml 2ml 3ml |
VTM 1M-OSA-T2 VTM 2M-OSA-T2 VTM 3M-OSA-T2 |
|
|
12ml Screw Cap Tube Nucleic acid Preservation Medium Cervical Swab Applicator (CSA-T1) |
2ml 3ml |
VTM 2M-CSA-T1 VTM 3M-CSA-T1 |
|
Information and intended Use
1) Nasopharyngeal(NP) & Oropharyngeal(OP) Swab samples are the preferred specimens for respiratory virus rapid antigen and Real-Time PCR testing.
2) The NP & OP swab have a white plastic shaft, with 3 (NP) and 2(OP) different thicknesses respectively, ending in a flock tip.
3) There is a deep score mark(V) on the thick part as a breakpoint where it can be snapped into the transport medium.
|
Description |
Flocked Mini Tip Swab Applicator [NP & OP Flocked Swab] |
|---|---|
| The Swab Type | NSA-T1 & OSA-T1 |
| Full length of applicator | NP swab : 150mm & OP Swab : 155mm |
| Breakpoint Distance | NP swab 80mm, OP swab 30mm |
| Use | VTM, POCT diagnosis |
Non-inactivation type disposable virus sampling kit is a sampling VTM for collecting virus specimens, such as saliva, nasal swab and pharyngeal swab which may contains flu virus, SARS-CoV-2, etc. The preservation solution uses the PBS buffer formula, adding fetal bovine serum(FBS) and antibiotics. It has a good preservation effect, prevents bacterial and fungal contamination, and can maintain the activity of the virus for nucleic acid detection, virus isolation and other purposes.
Inactivation Type disposable Virus Sampling kit is a collection VTM for collect virus specimens, such as saliva, nasal swab and pharyngeal swab which may contains flu virus, SARS-CoV-2, etc. The preservation solution in the tube can protect the viral nucleic acid from degradation for one week at room temperature (15 ~ 25°C). The preservation solution has the function of cell lysis and is compatible with all kinds of lysis buffers in the virus DNA/RNA extraction kits. In the subsequent nucleic acid extraction process, less or no lysate can be added to increase the sample dosage, so that more nucleic acids can be obtained and the detection results can be more accurate. And the sampling is convenient to avoid cross-contamination during large-scale sample processing.
Disposable Virus Sampling Tube (Extraction-Free & Direct PCR Type) is used to rapidly release nucleic acids from nasopharyngeal swabs, oropharyngeal swabs and saliva samples. After nucleic acid is released, it can be directly used as a template for nucleic acid amplification, such as PCR, qPCR, RT-qPCR and isothermal amplification without nucleic acid purification. The lysis material contained in the storage solution in the sample tube can inactivate the virus quickly. After releasing the nucleic acid in the sample, the nucleic acid protection component can effectively preserve nucleic acid.
100 Tests/Inner Box
Option : In the case of 100 tests, labeling is attached or
supplied separately according to the buyer's request.
50 Tests/Inner Box
Composition
Composition
The competitiveness of our products compared to other products
The head of a typical nasal swab is short. Thus, a small amount of samples are often taken, and it causes pain when put into the nose by having a pointy tip.
However, WIZCHEM’s nasal swabs with long heads can take a lot of samples. And a round ball is added to the top of the fifth nasal swab to prevent pain during the test.
[Fig. 1] Remove the cover sheet of the Nuclear acid Preservation & Transport Medium.
[Fig. 2] Remove the protective tube of the sample collection swab and use the swab to collect the patient's samples.
[Fig. 3] Close the collected swab to the transport medium as shown in Figure 3, then apply downward force to cut.
[Fig. 4] Close the tube cap of the transport medium tightly, fill in the patient's information, and transport it to the examination institution.
Upper Respiratory Tract
Nasopharyngeal (NP) Swab + Oropharyngeal (OP) Swab
Nasopharyngeal (NP) Swab can be collected scratching the nasopharynx through the nostril.
Oropharyngeal (OP) Swab can be collected scratching the pharynx having your tongue down.
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Symbol |
Explanation |
|---|---|
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Catalog number |
|
CE mark |
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In-vitro diagnostics medical device |
|
Batch code |
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Expiration date |
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Sufficient for <n> tests |
|
Consult instructions for use |
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Temperature limit |
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Do not re-use |
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Do not re-sterilize |
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Do not use if package is damaged. |
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Caution, consult accompanying documents |
|
Manufacturer |
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Manufacture date |
|
Authorized representative in the European Community |
Manufacturer
Bio Ventrue Town 401-404, Daejeon Techno-Park, 1662, Yuseong-daero, Yuseong-gu, Daejeon, 34054, Republic of Korea
CDC is now recommending collecting only the NP swab, although OP swabs remain an acceptable specimen type. If both NP and OP swabs are collected, they should be combined in a single tube to maximize test sensitivity and limit use of testing resources. Please refer to the protocol in the "Microbiology Specimen Collection Manual".
CE-DOC
FDA-EUA
더보기
CE-COC (Swabs)
CFS
EU Notification
Manufacturing certificate of medical devices and in vitro diagnostic devices
COVICHEK™ Saliva Collection Kit is an easy to use DNA and RNA saliva collection device that stabilizes DNA and RNA long term in saliva sample.
The saliva collection tube clearly indicates the volume of saliva required after which the funnel is removed and cap replaced.
The device is fully specified for sample transport and storage.
COVICHEK™ Saliva Collection Kit is an easy-to-use DNA/RNA saliva collection device that stabilizes DNA/RNA in saliva samples for long periods of time. The saliva collection tube clearly indicates the volume of saliva required after which the funnel is removed and cap replaced. The device is fully specified for sample transport and storage.
1. COVICHEK™ Saliva Collection Kit is an easy to use DNA and RNA saliva collection device that stabilizes DNA / RNA long term in saliva sample.
2. The saliva collection tube clearly indicates the volume of saliva required after which the funnel is removed and cap replaced.
3. The collector is pre-filled and has a simple screw-on funnel for simple saliva delivery directly into the non-toxic stabilization buffer. The device is fully specified for sample transport and storage.
4. The unique funnel design prevents flow back and can also be used with our assisted option using foam swabs to collect saliva from babies, elderly or any donor unable to use the funnel.
| Catalog No. / Model No. |
Tube (Size) | Solution Type | Dosage | Manufacturer Product Number / Code |
Funnel | Test/Kit |
|---|---|---|---|---|---|---|
| SCK-1M-FT1 (PS-01T) | SCK: Saliva Collector (5, 8, 12ml) | PS: Preservation | 1ml | SCK-PS-1M-FT1-01T | FT1 : Funnel | 01T : 1 |
| SCK-1M-FT1 (PS-25T) | SCK: Saliva Collector (5, 8, 12ml) | PS: Preservation | 1ml | SCK-PS-1M-FT1-25T | FT1 : Funnel | 25T : 25 |
| SCK-2M-FT1 (PS-01T) | SCK: Saliva Collector (5, 8, 12ml) | PS: Preservation | 2ml | SCK-PS-2M-FT1-01T | FT1 : Funnel | 01T : 1 |
| SCK-2M-FT1 (PS-25T) | SCK: Saliva Collector (5, 8, 12ml) | PS: Preservation | 2ml | SCK-PS-2M-FT1-25T | FT1 : Funnel | 25T : 25 |
| SCK-3M-FT1 (PS-01T) | SCK: Saliva Collector (5, 8, 12ml) | PS: Preservation | 3ml | SCK-PS-3M-FT1-01T | FT1 : Funnel | 01T : 1 |
| SCK-3M-FT1 (PS-25T) | SCK: Saliva Collector (5, 8, 12ml) | PS: Preservation | 3ml | SCK-PS-3M-FT1-25T | FT1 : Funnel | 25T : 25 |
| SCK-1M-FT1 (IA-01T) | SCK: Saliva Collector (5, 8, 12ml) | IA: Inactivation | 1ml | SCK-IA-1M-FT1-01T | FT1 : Funnel | 01T : 1 |
| SCK-1M-FT1 (IA-25T) | SCK: Saliva Collector (5, 8, 12ml) | IA: Inactivation | 1ml | SCK-IA-1M-FT1-25T | FT1 : Funnel | 25T : 25 |
| SCK-2M-FT1 (IA-01T) | SCK: Saliva Collector (5, 8, 12ml) | IA: Inactivation | 2ml | SCK-IA-2M-FT1-01T | FT1 : Funnel | 01T : 1 |
| SCK-2M-FT1 (IA-25T) | SCK: Saliva Collector (5, 8, 12ml) | IA: Inactivation | 2ml | SCK-IA-2M-FT1-25T | FT1 : Funnel | 25T : 25 |
| SCK-3M-FT1 (IA-01T) | SCK: Saliva Collector (5, 8, 12ml) | IA: Inactivation | 3ml | SCK-IA-3M-FT1-01T | FT1 : Funnel | 01T : 1 |
| SCK-3M-FT1 (IA-25T) | SCK: Saliva Collector (5, 8, 12ml) | IA: Inactivation | 3ml | SCK-IA-3M-FT1-25T | FT1 : Funnel | 25T : 25 |
| SCK-1M-FT1 (DP-01T) | SCK: Saliva Collector (5, 8, 12ml) | DP: Direct PCR | 1ml | SCK-DP-1M-FT1-01T | FT1 : Funnel | 01T : 1 |
| SCK-1M-FT1 (DP-25T) | SCK: Saliva Collector (5, 8, 12ml) | DP: Direct PCR | 1ml | SCK-DP-1M-FT1-25T | FT1 : Funnel | 25T : 25 |
| SCK-2M-FT1 (DP-01T) | SCK: Saliva Collector (5, 8, 12ml) | DP: Direct PCR | 2ml | SCK-DP-2M-FT1-01T | FT1 : Funnel | 01T : 1 |
| SCK-2M-FT1 (DP-25T) | SCK: Saliva Collector (5, 8, 12ml) | DP: Direct PCR | 2ml | SCK-DP-2M-FT1-25T | FT1 : Funnel | 25T : 25 |
| SCK-3M-FT1 (DP-01T) | SCK: Saliva Collector (5, 8, 12ml) | DP: Direct PCR | 3ml | SCK-DP-3M-FT1-01T | FT1 : Funnel | 01T : 1 |
| SCK-3M-FT1 (DP-25T) | SCK: Saliva Collector (5, 8, 12ml) | DP: Direct PCR | 3ml | SCK-DP-3M-FT1-25T | FT1 : Funnel | 25T : 25 |
1) Saliva has been studied thoroughly as a potential diagnostic tool and it is expected to become a substitute for other biological fluids such as serum or urine in disease diagnosis.
2) Saliva has been described as a good candidate for diagnosis of COVID-19, showing sensitivity and specificity comparable to nasopharyngeal swabs.
3) Saliva contains hormones, antibodies, growth factors, enzymes, microbes. Saliva is used for the diagnosis of several diseases including hereditary diseases, autoimmune diseases, malignancies, infections, dental caries and periodontal disease.
4) Additionally, saliva can be used for diagnosing oral diseases with relevance for systemic diseases or for monitoring of levels of hormones, drugs and bone turnover markers.
Transport medium for saliva sample collection and nucleic acid preservation for molecular diagnosis for All viruses(COVID-19, Respiratory Syncytial Virus, Influenza A and B, etc.) and for Enzyme Immuno Assays (EIA)
Non-inactivation type disposable virus sampling kit is a sampling kit for collecting virus specimens, such as saliva, nasal swab and pharyngeal swab which may contains flu virus, SARS-CoV-2, etc. The preservation solution uses the PBS buffer formula, adding fetal bovine serum(FBS) and antibiotics. It has a good preservation effect, prevents bacterial and fungal contamination, and can maintain the activity of the virus for nucleic acid detection, virus isolation and other purposes.
Inactivation Type disposable Virus Sampling kit is a collection kit for collect virus specimens, such as saliva, nasal swab and pharyngeal swab which may contains flu virus, SARS-CoV-2, etc. The preservation solution in the tube can protect the viral nucleic acid from degradation for one week at room temperature (15 ~ 25°C). The preservation solution has the function of cell lysis and is compatible with all kinds of lysis buffers in the virus DNA/RNA extraction kits. In the subsequent nucleic acid extraction process, less or no lysate can be added to increase the sample dosage, so that more nucleic acids can be obtained and the detection results can be more accurate. And the sampling is convenient to avoid cross-contamination during large-scale sample processing.
Disposable Virus Sampling Tube (Extraction-Free & Direct PCR Type) is used to rapidly release nucleic acids from nasopharyngeal swabs, oropharyngeal swabs and saliva samples. After nucleic acid is released, it can be directly used as a template for nucleic acid amplification, such as PCR, qPCR, RT-qPCR and isothermal amplification without nucleic acid purification. The lysis material contained in the storage solution in the sample tube can inactivate the virus quickly. After releasing the nucleic acid in the sample, the nucleic acid protection component can effectively preserve nucleic acid.
Composition
Composition
1) WIZCHEM Saliva Nucleic Acid Preservation & Transport(NAPT) Medium is a transport medium for preserving nucleic acids that can be stored reliably at room temperature after Saliva sampling - clinical specimens.
2) The sample can be safely transported through the use of a sample transport container, and the structure is convenient and centrifugal separation can be used using a self-standing mechanical tube.
3) Place the samples in a nucleic acid preservation medium and keep the DNA stable at room temperature for more than five months and RNA stable for more than a week.
4) Saliva Nucleic Acid Preservation & Transport(NAPT) Medium is stable for 12 months at room temperature.
5) Specimens in Saliva Nucleic Acid Preservation & Transport(NAPT) medium are stable for 48 hours at room temperature.
6) Saliva biomarkers have a potential to be an important guide in COVID-19 prognosis, making possible the development of point-of-care devices.
7) The test procedures for quality control are based upon the quality control methods described in CLSI M40-A2 and others.
1) This Saliva Viral DNA/RNA Collection Kit is suitable for rapid extraction of high purity viral nucleic acid from saliva, sputum, bronchus/alveolar lavage fluid as well as nasopharyngeal(NP) & oropharyngeal (OP) swabs.
2) The obtained nucleic acids can be directly used in downstream related experiments such as reverse transcription, PCR, RT-PCR, fluorescence quantitative PCR, second-generation sequencing and Northern hybridization.
1) Remove the cap and fit the funnel into the tube.
2) Add the amount of saliva needed for the funnel.
3) Remove the funnel and fit the cap.
4) Shake the tube from side to side.
1) Saliva collection is easier to perform and less discomfort than taking a sample with a swab deep into the nasal cavity or throat.
2) Because Medical workers do not need to collect samples separately, they can reduce their risk of disease infection. (In highly infected regions such as EU, the United States and many other countries, infection by medical personnel is a very serious problem.)
3) Saliva collection is faster and more scalable than swab collection, which can increase the number of people inspected each day.
1. Convenient and effective virus storage & Suitable for collecting SARS-CoV-2 samples.
2. Non-invasive approach for disease diagnosis and monitoring of general health.
3. Painless (no patient discomfort and anxiety for sampling).
4. Easy collection and applicable in remote areas & Suitable for on-site, home and clinic-based sampling).
5. Relatively cheap technology (Cheap to store and ship)
6. Cost-effective applicability for screening large populations.
7. Suitable for children, anxious/disabled/elderly patients.
8. Safer collection for health professionals than other biological samples such as nasopharyngeal swabs and blood.
9. Easy to handle & Possible multisampling.
10. No need for expensive equipment/instruments (swabs, suction tubes or special collection devices) for collection. Only needs a sterile container.
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Symbol |
Explanation |
|---|---|
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Catalog number |
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CE mark |
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In-vitro diagnostics medical device |
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Batch code |
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Expiration date |
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Sufficient for <n> tests |
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Consult instructions for use |
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Temperature limit |
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Do not re-use |
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Do not re-sterilize |
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Do not use if package is damaged. |
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Caution, consult accompanying documents |
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Manufacturer |
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Manufacture date |
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Authorized representative in the European Community |
Manufacturer
Bio Ventrue Town 401-404, Daejeon Techno-Park, 1662, Yuseong-daero, Yuseong-gu, Daejeon, 34054, Republic of Korea
CE (DOC)
FDA Registeration
CFS
In vitro diagnostic medical device
manufacturing report certificate
EU Notification
Simple and Fast | Wide Versatility | Safe | High Purity | High Yield
1) Simple and Fast : Extraction is completed in 30 minutes, and it can be used for automatic detection.
2) Wide Versatility : It is suitable for viral nucleic acid extraction from nasopharyngeal swab, saliva, sputum, bronchus lavage fluid and alveolar lavage fluid, etc.
3) Safe : No toxic reagents such as phenol and chloroform are needed in the extraction process.
4) High Purity : Remove inhibitive impurities to the maximum extent, the obtained high purity nucleic acid can be directly used for RT-qPCR.
5) High Yield : The nucleic acid recovery efficiency is very high, making the downstream more sensitive.
W 4001
The Kit consists of the following components.
|
No. |
Reagent |
Image |
Volume |
Description |
|---|---|---|---|---|
| 1 | Lysis Buffer |
|
30ml | Provide environment for lysing and binding to the column |
| 2 | Washing Buffer 1 |
|
80ml |
Remove residual proteins and other impurities (Add 60ml absolute ethanol before use) |
| 3 | Washing Buffer 2 |
|
80ml |
Purify viral nucleic acids (Add 72ml absolute ethanol before use) |
| 4 | Elution Buffer |
|
20ml | Nuclease-free solution, elute viral nucleic acids |
| 5 | Spin Column |
|
100pcs | Adsorb viral nucleic acid and collect the filtrate |
| 6 | 1.5ml Collection Tube |
|
100pcs | Collection of eluted viral nucleic acid |
Storage condition
Store at room temperature (15 ~ 25°C) and transport at room temperature.
Viral DNA/RNA Extraction
|
No. |
Step |
Image |
Description |
Note |
|---|---|---|---|---|
| 1 | Lysis |
|
Add lysis buffer to sample Sample: 200㎕ Lysis buffer: 500㎕ |
|
| 2 | Incubation |
|
1) Mix by vortexing for 15 seconds 2) Waiting for 10 min at room temperature |
|
| 3 | Precipitation |
|
1. Add absolute ethanol 400㎕ and mix. 2. Centrifuge and transfer supernant to spin column. |
12,000 x g for 1 minute |
| 4 | Column binding |
|
Centrifuge and discard the filtrate. | Centrifuge at 12,000ⅹg for 30~60 seconds |
| 5 | 1st Washing |
|
1) Add 700㎕ of washing buffer 1 to spin column. 2) Centrifuge 3) Discard the filtrate |
Centrifuge at 12,000ⅹg for 30~60 seconds |
| 6 | 2nd Washing |
|
1) Add 700㎕ of washing buffer 2 to spin column 2) Centrifuge 3) Discard the filtrate |
Centrifuge at 12,000ⅹg for 30~60 seconds |
| 7 | Elution |
|
1) Transfer the spin column to a new 1.5 ml Collection Tube (provided by the kit) 2) Add 50~100㎕ of elution buffer to spin column 3) Centrifuge |
Centrifuge at 13,000ⅹg for 3~5 minutes |
| 8 | Usage & Storage |
|
The obtained DNA/RNA can be directly used for the subsequent detection, or be store at -15 ~ -30℃ for short-term storage or at -70℃ long-term storage. |
Real-Time PCR Mix : One-Step Probe RT-qPCR KIT
RNA extracted from 2019 n-CoV abEN Pseudovirus by Swab Viral DNA/RNA Extraction Kit (Cat. No. W4001)
ORF1ab
N gene
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Symbol |
Explanation |
|---|---|
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Catalog number |
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CE mark |
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In-vitro diagnostics medical device |
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Batch code |
|
|
Expiration date |
|
|
Sufficient for <n> tests |
|
|
Consult instructions for use |
|
|
Temperature limit |
|
|
Do not re-use |
|
|
Do not re-sterilize |
|
|
Do not use if package is damaged. |
|
|
Caution, consult accompanying documents |
|
|
Manufacturer |
|
|
Manufacture date |
|
|
Authorized representative in the European Community |
Manufacturer
Bio Ventrue Town 401-404, Daejeon Techno-Park, 1662, Yuseong-daero, Yuseong-gu, Daejeon, 34054, Republic of Korea
CFS
CE (DOC)
EU Notification
In vitro diagnostic medical device manufacturing report certificate
FDA Registration & Listing
Product Name : COVID-19 Fast Detection Kit
Certificate : GMP, ISO 13485 and CE-IVD
Catalog Number : CFP901
| Components | 100 Tests/Kit |
|---|---|
| COVICHEK™ Fast Master mixture | 1,000 μL |
| COVICHEK™ COVID-19 PP mixture | 500 μL |
| Positive Control | 100 μL |
※ It is recommended that the components are completely thawed and mixed gently before use.
COVICHEK™ COVID-19 Fast Detection Kit is a real-time RT-PCR (reverse transcriptase polymerase chain reaction) test intended for the qualitative detection of nucleic acids from SARS-CoV-2 in nasopharyngeal swab, oropharyngeal swab and sputum specimens collected from any individuals suspected of COVID-19 by their healthcare providers.
Use viral RNA samples from human respiratory specimens such as nasopharyngeal swabs, anterior nasal swabs, oropharyngeal swabs, saliva and sputum.
Use viral RNA samples from human respiratory specimens such as nasopharyngeal swabs, anterior nasal swabs, oropharyngeal swabs, saliva and sputum.
| Components | Volume (μL) |
|---|---|
| COVICHEK™ Fast Master Mixture | 10 |
| COVICHEK™ COVID-19 PP Mixture | 5 |
| Template RNA | 5 |
| Total | 20 |
1. Make PCR reaction mixture by referring to the table.
2. Mix the reaction mixture except the template and spin-down briefly. Aliquot 15 μL of the mixture into each well of PCR plate.
3. Add 5 μL of the template RNA.
4. Prepare positive control (PC) and negative control (NC) in the same manner. Use RNase-free water for NC.
5. Spin-down the plate briefly and run the PCR reaction immediately
- This protocol is validated on QuantStudio 5 (Thermo Fisher) and CFX96 (Bio-Rad) Real-time PCR instrument system.
- Set up the PCR program and fluorescence as following and start reaction.
| PCR step | Tm (℃) | duration | Cycle |
|---|---|---|---|
| Reverse Transcription | 50 | 5 min | 1 |
| Pre-Heating | 95 | 30 sec | 1 |
| Pre-amplification | 95 | 1 sec | 5 |
| 58 | 1 sec | ||
| Amplification | 95 | 1 sec | 35 |
| 58 | 1 sec | ||
| 35 | |||
| Ramp Rate Setting | ||
|---|---|---|
| Instrument | Up Ramp | Down Ramp |
| QuantStudio 5 | 3.29 ℃/sec | 2.5 ℃/sec |
| CFX96 | 5 ℃/sec | Default |
| Fluorescence Setting | ||
|---|---|---|
| Target | Fluorophore | |
| RdRp gene | FAM | |
| N gene | VIC | |
| Internal Control (IC) | Cy5 | |
The values of fluorescence emitted by specific probes and by the specific internal control probe in amplification reactions should be analyzed by the instrument software.
1. Click analysis mode after completion and choose analysis setting from Amplification Plot.
2. Click “Edit Default Settings” to set threshold values as shown below.
| Target | Threshold | |
|---|---|---|
| QuantStudio 5 | CFX96 | |
| RdRp gene | 5,000 | 300 |
| N gene | 5,000 | 300 |
| IC | 5,000 | 300 |
3. Cut-off
| RdRp gene | N gene | IC |
|---|---|---|
| ≤35 | ≤35 | ≤35 |
| No. | RdRp | N | IC* | Assay Result |
|---|---|---|---|---|
| 1 | + | + | +/- | COVID-19 Positive |
| 2 | + | - | +/- | Inconclusive |
| 3 | - | + | +/- | Inconclusive |
| 4 | - | - | + | COVID-19 Negative |
| 5 | - | - | - | Invalid |
※ Even if the target peak is detected only without IC peak, the target peak is available (Positive).
CE-DOC
In vitro diagnostic medical device manufacturing report certificate
COVICHEK™ SWABS are manufactured with over 150 pores per inch reticulated polyurethane foam, which ensures excellent absorbency while minimizing contamination.
Tips are affixed by heat seal to prevent tip loss, even while saturated with solvent.
Flexible tips provide versatility and softer touch.
1. Nasopharyngeal(NP) & Oropharyngeal(OP) Swab samples are the preferred specimens for respiratory virus RT PCR Test.
2. The NP & OP swab have a white plastic shaft, with 3 (NP) and 2(OP) different thicknesses respectively, ending in a flock tip.
3. There is a deep score mark(V) on the thick part as a breakpoint where it can be snapped into the transport medium.
|
Description |
Flocked Mini Tip Swab Applicator : NP & OP Flocked Swab |
|---|---|
| Model Number | NSA-T1 & OSA-T1 |
| Full length of applicator | NP swab : 150mm & OP Swab : 155mm |
| Breakpoint Distance | NP swab 80mm, OP swab 30mm or 80mm |
| Use | VTM (Viral Transport Medium) |
1. Nasopharyngeal(NP) Swab samples are the preferred specimens for respiratory virus rapid antigen testing.
2. The NP swabs have a white plastic shaft with 2 different types ending in flocked ball tip head – breakpoint & no breakpoint.
1) NP swab with 80mm breakpoint for VTM, 2) NP swab with no breakpoint for Antigen Rapid Kit
|
Description |
Flocked Mini Tip Swab Applicator : NP Flocked Swab |
|---|---|
| Model Number | NSA-T2 |
| Full length of applicator | NP swab : 150mm |
| Breakpoint Distance | NSA-T2 - No Breakpoint |
| Use | POCT diagnosis (eg. Ag Kit) |
NSA-T2
(no breakpoint)
1. Nasal Swab samples are the preferred specimens for respiratory virus rapid antigen and Real-Time PCR testing by self-collection of specimen.
2. The nasal swabs have a white plastic shaft with 2 different types ending in foam head – 30mm & 80 mm breakpoints.
3. Applications : specimen collection for Antigen Rapid Kit & VTM
|
Description |
Head of Swab Applicator : Foam Swab |
|---|---|
| Model Number | OSA-T2 |
| Full length of applicator | Anterior Nasal swab : 150mm |
| Breakpoint Distance | 30mm or 80mm breakpoint |
| Use | POCT diagnosis, Molecular diagnosis |
OSA-T2
(30mm breakpoint)
OSA-T2
(80mm breakpoint)
1. Nasal Swab samples are the preferred specimens for respiratory virus rapid antigen testing by self-collection of specimen.
2. The nasal swabs have a white plastic shaft with foam head – No breakpoint.
3. Applications: specimen collection for Antigen Rapid Kit
|
Description |
Swab Applicator : AN Foam Swab |
|---|---|
| The Swab Type (Model No.) | NSA-T3 |
| Full length of applicator | Anterior Nasal Swab : 80mm |
| Breakpoint Distance | No Breakpoint |
| Use | POCT diagnosis (eg. Ag Kit) |
1. Throat Swab samples are the preferred specimens for respiratory virus rapid antigen and Real-Time PCR testing by self-collection of specimen.
2. The Throat swabs have a white plastic shaft with 2 different types ending in foam head – 30mm & 80 mm breakpoints.
3. Applications: specimen collection for Antigen Rapid Kit & VTM
|
Description |
Head of Swab Applicator : Foam Swab |
|---|---|
| Model Number | OSA-T3 |
| Full length of applicator | Throat swab : 150mm |
| Breakpoint Distance | 30mm and/or 80mm breakpoint |
| Head Size | Thickness 10mm & Length 20mm |
| Use | POCT diagnosis, Molecular diagnosis |
OSA-T3
(30mm and/or 80mm breakpoint)
|
Item |
Nasopharyngeal Swab |
Nasal swab |
|---|---|---|
|
Product Image |
|
|
|
Head Type |
Flocked head |
Foam head |
|
Head Photo |
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|
Characteristic |
At the microscopic level, the synthetic tip of a flocked swab is more abrasive than cotton and is therefore able to recover and elute more specimens. The brush-like tip of the flocked swab also provides for better sample collection and specimen release during testing. |
Medical grade foam is also used as a tip material for diagnostics The advantage of using a foam tipped swab is that they come in various tip shapes, sizes and porosities, so your intended use dictates which foam tipped swabs will work best. |
The head of a typical nasal swab is short. Thus, a small amount of samples are often taken, and it causes pain when put into the nose by having a pointy tip. However, COVICHEKTM swabs with long heads can take a lot of samples. And a round ball is added to the top of the fifth nasal swab to prevent pain during the test. And the stick is not bent and has good elasticity, so it is very easy to collect samples.
CFS
CE (DOC)
FDA-EUA
CE-COC (Swabs)
Medical device manufacturing report
SGS-REACH TEST
EU Notification
Product Name : COVID-19 Ag Kit
Certificate : GMP, ISO 13485 and CE-IVD
Catalog Number : CAG301
| Test No. / Kit | 1 test, 2 tests, 5 tests, 10 tests, 25 tests / Kit | ||
| Storage | 2~30℃ / 36~86°F | Shelf Life | 24 months |
| Components |
|---|
| Test device |
| Extraction solution tube |
| Sample developing filter cap |
| Sterilized nasal swabs for sample collection |
| Instructions for use |
When the sample and the extraction solution are applied to the sample well,
the sample is moved to the gold conjugated pad and reacts with anti-SARS-CoV-2
monoclonal antibody-coupled gold conjugate followed by reaction with anti-SARS-CoV-2
monoclonal antibody immobilized in the test line. When the sample contains SARS-CoV-2
antigens, a visible line appears in the test region on the membrane.
The solution continues to migrate to encounter a control reagent that binds a
control conjugate, thereby producing another band in the control region.
The COVICHEK™ COVID-19 Ag Kit is also very useful to directly detect
SARS-CoV-2 antigens from human nasal swab samples.
1) Negative : The presence of only control line (C) within the result window indicates a negative result.
2) Positive : The presence of two control line (C) and test line (T) within the result window, no matter which band appears first indicates a positive result.
3) Invalid : If the control line (C) is not visible within the result window after performing the test, the result is considered invalid.
| 1 TEST | 2 TESTS | 5 TESTS | 25 TESTS |
|---|---|---|---|
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|
|
|
CE-DOC
CFS
EU Notification
In vitro diagnostic medical device manufacturing report certificate
Product Name : COVID-19 Ag Kit
Certificate : GMP, ISO 13485 and CE-IVD
Catalog Number : CAG301
| Test No. / Kit | 25 tests / Kit | ||
| Storage | 2~30℃ / 36~86°F | Shelf Life | 24 months |
| Components |
|---|
| Test device |
| Extraction solution tube |
| Sample developing filter cap |
| Sterilized nasopharyngeal swabs for sample collection |
| Instructions for use |
The COVICHEK™ COVID-19 Ag Kit is an immunoassay kit for rapid and qualitative determination of
SARS-CoV-2 infection from nasopharyngeal swab specimens.
When the sample and the extraction solution are applied to the sample well, the sample is moved to the gold
conjugated pad and reacts with anti-SARS-CoV-2 monoclonal antibody-coupled gold conjugate followed by
reaction with anti-SARS-CoV-2 monoclonal antibody immobilized in the test line. When the sample contains SARS-CoV-2
antigens, a visible line appears in the test region on the membrane. The solution continues to migrate to encounter
a control reagent that binds a control conjugate, thereby producing another band in the control region.
The COVICHEK™ COVID-19 Ag Kit is also very useful to directly detect SARS-CoV-2 antigens from human swab samples.
1) Negative : The presence of only control line (C) within the result window indicates a negative result.
2) Positive : The presence of two control line (C) and test line (T) within the result window, no matter which band appears first indicates a positive result.
3) Invalid : If the control line (C) is not visible within the result window after performing the test, the result is considered invalid.
CE-DOC
CFS
EU Notification
In vitro diagnostic medical device manufacturing report certificate
Product Name : COVID-19 Ag SALIVA HT
Certificate : GMP, ISO 13485 and CE-IVD
Catalog Number : CAG301S
| Test No. / Kit | 1 test, 2 tests, 5 tests, 10 tests, 25 tests / Kit | ||
| Storage | 2~30℃ / 36~86°F | Shelf Life | 24 months |
| Components |
|---|
| Test device |
| Extraction solution tube |
| Sample developing filter cap |
| Mini-Funnel (Model No. FT-2) |
| Instructions for use |
When the sample and the extraction solution are applied to the sample well, the sample is moved to the gold
conjugated pad and reacts with anti-SARS-CoV-2 monoclonal antibody-coupled gold conjugate followed by
reaction with anti-SARS-CoV-2 monoclonal antibody immobilized in the test line. When the sample contains SARS-CoV-2
antigens, a visible line appears in the test region on the membrane. The solution continues to migrate to encounter
a control reagent that binds a control conjugate, thereby producing another band in the control region.
The COVICHEK™ COVID-19 Ag SALIVA HT is also very useful to directly detect SARS-CoV-2 antigens from human swab samples.
1) Negative : The presence of only control line (C) within the result window indicates a negative result.
2) Positive : The presence of two control line (C) and test line (T) within the result window, no matter which band appears first indicates a positive result.
3) Invalid : If the control line (C) is not visible within the result window after performing the test, the result is considered invalid.
| 1 TEST | 2 TESTS | 5 TESTS | 25 TESTS |
|---|---|---|---|
|
|
|
|
CE-DOC
CFS
EU Notification
In vitro diagnostic medical device manufacturing report certificate
Product Name : COVID-19 Ag Test At-Home
Certificate : GMP, ISO 13485 and CE-IVD
Catalog Number : CAG301H
For in vitro diagnostics use only
| Method | Immunochromatographic | Test No. / Kit | 25 Tests / Kit |
| Storage | 2~30℃ / 36~86°F | Shelf Life | 24 months |
| Components | 25 Tests/Kit |
|---|---|
| Test strip (device) | 25 EA |
| Sterile specimen collection swab | 25 EA |
| Extraction buffer tube | 25 EA |
| Tube holder | 25 EA |
| Instructions for use | 1 EA |
This test is authorized for prescription home use with self-collected (unobserved) anterior nares (NS)
swab specimens directly from individuals aged 14 years and older who are suspected of COVID-19 by their
healthcare provider within the first six days of the onset of symptoms.
Persons who test positive with the COVICHEK™ COVID-19 Ag Test At-Home should self-isolate and seek
follow-up care with their physician or healthcare provider as additional testing may be necessary and for
public health reporting.
1) Positive : A positive result must show both a blue line and a red line near the blue line. The intensity of the lines may vary. A positive test result means that proteins from the virus that causes COVID-19 were found in your sample and it is very likely you have COVID-19 and it is important to be under the care of your healthcare provider.
2) Negative : A negative result will show a blue line but no red line a negative test result means that proteins from the virus that cases COVID-19 were not found in your sample.
3) Invalid : If there are no lines or only red lines, the test is not valid. If a 10 minutes, the blue control line does not appear, even if any shade of pink to-red test line appears, the result is invalid. If the test result is invalid, a new swab should be collected, and the test should be performed again with a new pre-filled tube and test strip.
| 1 TEST | 2 TESTS | 5 TESTS | 10 TESTS | 25 TESTS |
|---|---|---|---|---|
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CE-DOC
CFS
EU Notification
Product Name : COVID-19 Ag Saliva Test At-Home
Certificate : GMP, ISO 13485 and CE-IVD
Catalog Number : CAG301H-25-FT-2
For in vitro diagnostics use only
| Method | Immunochromatographic | Test No. / Kit | 25 Tests / Kit |
| Storage | 2~30℃ / 36~86°F | Shelf Life | 24 months |
| Components | 25 Tests/Kit |
|---|---|
| Test strip (device) | 25 EA |
| Extraction buffer tube | 25 EA |
| Instructions for use | 25 EA |
This test is authorized for prescription home use with self-collected (unobserved)
anterior nares (NS) swab specimens directly from individuals aged 14 years and older
who are suspected of COVID-19 by their healthcare provider within the first six days of the onset of symptoms.
Persons who test positive with the COVICHEK™ COVID-19 Ag Saliva Test At-Home should self-isolate
and seek follow-up care with their physician or healthcare provider as
additional testing may be necessary and for public health reporting.
1) Positive : A positive result must show both a blue line and a red line near the blue line. The intensity of the lines may vary. A positive test result means that proteins from the virus that causes COVID-19 were found in your sample and it is very likely you have COVID-19 and it is important to be under the care of your healthcare provider.
2) Negative : A negative result will show a blue line but no red line a negative test result means that proteins from the virus that cases COVID-19 were not found in your sample.
3) Invalid : If there are no lines or only red lines, the test is not valid. If a 10 minutes, the blue control line does not appear, even if any shade of pink to-red test line appears, the result is invalid. If the test result is invalid, a new swab should be collected, and the test should be performed again with a new pre-filled tube and test strip.
| 1 TEST | 2 TESTS | 5 TESTS | 10 TESTS | 25 TESTS |
|---|---|---|---|---|
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CE-DOC
CFS
EU Notification
Product Name : COVID-19 Neutralizing Ab Test
Certificate : GMP, ISO 13485 and CE-IVD
Catalog Number : CNA701
| Test No. / Kit | 1 test, 2 tests, 25 tests / Kit | ||
| Storage | 2~30℃ / 36~86°F | Shelf Life | 24 months |
| Components |
|---|
| Test device |
| Buffer tubes |
| Capillary tubes |
| Alcohol pads |
| Instructions for use |
COVICHEK™ COVID-19 Neutralizing Ab Test detects anti-SARS-CoV-2 neutralizing antibody that block the binding of RBD protein to the human cell receptor ACE2, by using the blocking (RBD protein and ACE2 protein) and double antigen sandwich (RBD protein and RBD protein) immunochromatography. The test card contains: 1) colloidal gold-labeled recombinant novel coronavirus S-RBD antigen, refer control and quality control antibody gold markers; 2) one detection line (T line), one reverse detection line (TR line) and one quality control line (C line) of nitrocellulose membrane. The TR line is immobilized with Human ACE2 protein for detecting novel coronavirus neutralizing antibody; the T line is immobilized with RBD protein; and the C line is immobilized with a quality control antibody. When an appropriate amount of the test sample is added to the sample hole of the test card, the sample will move forward along the test card under the action of the capillary. If the sample contains novel coronavirus neutralizing antibody, the antibody will bind to the colloidal gold-labeled novel coronavirus antigen.
| 1 TEST | 2 TESTS | 25 TESTS |
|---|---|---|
|
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1) High Positive : The intensive colored line appears in the control line region (C) and test line region (T), but no colored line appears in reverse test line region (TR). The result is high positive and neutralizing antibodies provide high protection.
2) Middle Positive : The intensive colored line appears in the control line region (C), and the medium-dense colored lines appear in test line region (T) and reverse test line region (TR) at the same time. The result is middle positive, and neutralizing antibodies provide middle protection.
3) Low Positive : The intensive colored line appears in the control line region (C), the weak-dense colored line appears in test line region (T), and strong-densed colored line appears in reverse test line region (TR) at the same time. The result is low positive and neutralizing antibodies provide weak protection.
4) Negative : The intensive colored line appears in the control line region (C) and reverse test line region (TR), but no colored line appears in test line region (T). The result is negative and no neutralizing antibodies in your body, and you are easily infected with the novel coronavirus If you are exposed to the virus.
5) Invalid : There is no line appeared in the C region, or no line appeared in the T and TR regions at the same time. Insufficient buffer volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the procedure with a new test device. If the problem persists, discontinue using the test kit immediately and contact your local distributor.
In order to manufacture safe and high-quality products, we have secured FDA, CE, GMP facilities and manufacture them with permission from the Korean FDA based on ISO 13485, prepare all kinds of documentary evidencesuch as E.O gas for sterilization, Certificate of Analysis, Gamma- Irradiation, CE mark certification,
ISO, etc. and sell them in Korea and abroad.
ISO 13485
COM
GMP
Manufacturing certificate of medical devices and in vitro diagnostic devices
For further information, please contact WIZCHEM.
Bio Venture Town 401-404, Daejeon Techno-Park, 1662, Yuseong-daero, Yuseong-gu, Daejeon, 34054, Korea
112, Oksansandan 4-ro, Oksan-myeon, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do, 28111, Korea
104, Munpyeongdong-ro 48beon-gil, Daedeok-gu, Daejeon, Korea
168-23, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do, Republic of Korea
Sinjeong-ri, Jeonui-myeon, Sejong-si, Republic of Korea.
Development of functional chemicals and electronic chemical materials
Bio-medi cosmetics with technologies derived from various skin physiological substances
For first aid, hydrofluoric acid burn skin external preparation, hydrofluoric acid neutralizer, etc.
NSA-T1
(80mm breakpoint)
OSA-T1
(80mm breakpoint)