• Reliable Visual COVID 19 Antigen Rapid Test Kit ISO13485 Certificate
  • Reliable Visual COVID 19 Antigen Rapid Test Kit ISO13485 Certificate
Reliable Visual COVID 19 Antigen Rapid Test Kit ISO13485 Certificate

Reliable Visual COVID 19 Antigen Rapid Test Kit ISO13485 Certificate

Product Details:

Place of Origin: China
Brand Name: Vchek
Certification: ISO13485
Model Number: 0674C4

Payment & Shipping Terms:

Minimum Order Quantity: negotiable
Price: negotiable
Packaging Details: 1/5/25test for one box
Delivery Time: 7days
Payment Terms: T/T, Western Union
Supply Ability: 3500000test/day
Get Best Price Contact Now

Detail Information

Sample Type:: Saliva Key Words: IFU EN 2019 NCoV 19 Saliva Ag EASY Test
Storage:: Room Temperature Accuracy:: 99.9%
Using:: Self Test Detection: Nucleocapsid Protein Antigen From 2019 NCoV
High Light:

Reliable Visual COVID 19 Test Kits ISO13485 Certificate

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Reliable Visual COVID 19 Rapid Test Kits ISO13485 Certificate

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Reliable Visual COVID 19 Rapid Test Kit ISO13485 Certificate

Product Description

IFU EN 2019 NCoV 19 Saliva Ag EASY Test

Whistling Test .pdf

 

Reliable and cost-effective SARS CoV-2 antigen rapid test


The easy-to-use test, utilising the standard lateral flow test cassette for the detection of SARS-CoV-2 virus antigen, provides reliable visual results after 10 minutes. The test kit is based on colloidal gold immunoassay technology.

It is an Ideal solution for fast and qualitative results in patients with onset of symptoms between 0-7 days

The collection of the specimen, using either a naso-/oropharyngeal sample or a saliva swab is very simple.

The sample is applied to the buffer tube and, afterwards, the prepared solution will be dripped onto the test strip.

After the incubation time, results are read manually by the operator.

 

 

INTERPRETATION OF TEST RESULTS

This product can only perform qualitative analysis on the detection object.

Positive Result:

If both C and T lines are visible within 10 minutes, the test result is positive and valid.

Negative Result:

If test area (T line) has no color and the control area displays a colored line, the result is negative and valid

Invalid Result:

The test result is invalid if a colored line does not form in the control region. The sample must be re-tested, using a new test.

 

Reliable Visual COVID 19 Antigen Rapid Test Kit ISO13485 Certificate 0

 

MATERIALS AND COMPONENTS

 

Materials provided with the test

 

 

Ingredients Cassette Instructions for use Quick Reference Instructions
 
Specifications
0674C4X001 1 1 NA
0674C4X002 2 1 NA
0674C4X005 3 1 1
0674C4X010 10 1 1
0674C4X020 20 1 1
0674C4X025 25 1 1

 

Materials required but not provided

  • Timer

 

STORAGE AND STABILITY

  • Store the test as packaged between 2-30°C.
  • The Test stable until the expiration date printed on the outer packing, the product will be expired after 24 months.
  • Do not use beyond the expiration date.
  • Do not freeze any contents of the test
  • The test must remain in the sealed pouch until use.

 

TEST PROCEDURE

Before test, please read the instructions carefully.

  • Take the cassette to equilibrate to room temperature.
  • Unpack the aluminum foil bag, take out the cassette.
  • Insert the absorber end of the cassette into mouth. Make sure cassette is horizontal statement.

Reliable Visual COVID 19 Antigen Rapid Test Kit ISO13485 Certificate 1

  • Actively swab the inside of the mouth and tongue to collect oral fluid.
  • Remove the absorber end from the mouth when the purple color move across the result window in the center of the test device.
  • Wait for 10 minutes and read the results.

NOTE:

*When sampling, gently hold it in mouth and let saliva naturally adsorb on the sponge.

*Do not eat, drink, or smoke prior to the test for at least 30 Minutes.

*Any saliva specimen is appropriate for testing but the saliva specimen collected in the morning, before mouth rinsed, eating or drinking, is recommended

 

 

 

INTERNAL CONTROL

The test contains a built-in internal control in the test card. A color band appearing in the control region (C) is designed as an internal control. The appearance of the control line confirms that sufficient flow has occurred, and that the test card is working normally. If the control line does not appear within 10 minutes, it is considered an error in the test result and it is recommended to test again with the same sample and a new device.

 

LIMITATIONS

  • The result of the test should not be taken as a confirmed diagnosis, for clinical reference only. Judgement should be made along with RT-PCR results, clinical symptoms, epidemiological information, and further clinical data.
  • The Test performance depends on the amount of virus (antigen) in the sample and may or may not correlate with viral culture results performed on the same sample.
  • The test must be equilibrated to room temperature (18℃~26℃) before used, otherwise the results may be incorrect
  • A negative test result may occur if the level of antigen in a sample is below the detection limit of the test.
  • Failure to follow the Test Procedure may adversely affect test performance and/or invalidate the test result.
  • React less than 10 minutes may lead a false negative result; React more than 10 minutes may lead a false positive result.
  • Positive test results do not rule out co-infections with other pathogens.
  • Negative test results are not intended to rule in other viral or bacterial infections.
  • Negative results should be treated as presumptive and confirmed with a molecular assay.
  • Clinical performance was evaluated with fresh samples.
  • Users should test specimens as quickly as possible after specimen collection.

 

PERFORMANCE CHARACTERISTIC

1. Clinical Verification

The performance of Test was established with 232 sample collected from symptomatic patients, who with symptoms onset within 7 days.

 

2019-nCoV Saliva Ag EASY TEST Comparative RT-PCR Test Result
(Immunochromatography)
  Positive (+) Negative (-) Total
Detected Positive 108 1 109
Detected Negative 7 116 123
Total 115 117 232
Sensitivity 93.91%, 95% CI (87.97,97.02)
Specificity 99.15%, 95% CI (95.32, 99.85)
Accuracy 96.55%, 95% CI (93.34, 98.24)

 

Positive results broken down by days since symptom onset:

Days since symptom onset RT-PCR Positive (+) 2019-nCoV Saliva Ag EASY CHECK PPA
(Immunochromatography)
1 13 13 100%
2 32 32 100%
3 52 51 98.08%
4 69 67 97.10%
5 86 83 96.51%
6 102 97 96.00%
7 115 108 93.91%

 

Positive results broken down by CT value:

 

2019-nCoV Saliva Ag EASY TEST Comparative RT-PCR Method
(Immunochromatography) (Positive by Ct Value)
  Positive (Ct<=25) Positive (25<Ct)
Detected Positive 69 39
Total 70 45
Positive agreement 98.57% 86.67%

 

2. Limit of Detection

The experimental results show that for the virus culture concentration above 100 TCID50/mL, the positive rate of detection is greater than or equal to 95%. For the virus culture concentration of 50 TCID50/mL and below, the positive rate of detection is lower than 95%. So, the limit of detection of the Test Card is 100 TCID50/mL.

3. Cross-reactivity

Cross-reactivity of the test card was evaluated. The results showed no cross reactivity with the following specimen.

 

No. Specimen type Conc.
1 HCoV-HKU1 105 TCID50/mL
2 Staphylococcus aureus 106 CFU / mL
3 Streptococcus pyogenes 106 CFU / mL
4 Measles virus 105 TCID50/mL
5 Paramyxovirus parotitis 105 TCID50/mL
6 Adenovirus 3 105 TCID50/mL
7 Mycoplasma pneumoniae 106 CFU / mL
8 Parainfluenza virus 2 105 TCID50/mL
9 Human Metapneumovirus (hMPV) 105 TCID50/mL
10 Human coronavirus OC43 105 TCID50/mL
11 Human coronavirus 229E 105 TCID50/mL
12 Human coronavirus NL63 104 TCID50/mL
13 MERS-Coronavirus EMC/2012 104 TCID50/mL
14 Bordetella parapertussia 106 CFU / mL
15 Influenza B (Victoria strain) 105 TCID50/mL
16 Influenza B (Y strain) 105 TCID50/mL
17 Influenza A (H1N1 2009) 105 TCID50/mL
18 Influenza A (H3N2) 105 TCID50/mL
19 Avian influenza virus (H7N9) 105 TCID50/mL
20 Avian influenza virus (H5N1) 105 TCID50/mL
21 Epstein-Barr virus 105 TCID50/mL
22 Enterovirus CA16 105 TCID50/mL
23 Rhinovirus 105 TCID50/mL
24 Respiratory syncytial virus 105 TCID50/mL
25 Streptococcus pneumoniae 106 CFU / mL
26 Candida albicans 106 CFU / mL
27 Chlamydia pneumoniae 106 CFU / mL
28 Bordetella pertussis 106 CFU / mL
29 Pneumocystis jirovecii 106 CFU / mL
30 Mycobacterium tuberculosis 106 CFU / mL
31 Legionella pneumophila 106 CFU / mL


4. Interference Substances

The test results do not be interfered with the substance at the following concentration:

 

 

No. Interference substances Conc.
1 Whole Blood 4%
2 Ibuprofen 1mg / mL
3 Tetracycline 3µg / mL
4 Chloramphenicol 3µg / mL
5 Erythromycin 3µg / mL
6 Tobramycin 5%
7 Throat spray(Menthol) 15%
8 Mupirocin 10mg/mL
9 Throat lozenge(Menthol) 1.5mg/mL
10 Tamiflu (Oseltamivir) 5mg/mL
11 Naphthoxoline hydrochloride nasal drops 15%
12 Mucin 0.50%
13 Fisherman's Friend 1.5mg/mL
14 Compound Benzocain Gel 1.5mg/mL
15 Cromoglycate 15%
16 Sinex (Phenylephrine Hydrochloride) 15%
17 Afrin (Oxymetazoline) 15%
18 Fluticasone propionate spray 15%

 

5. Precision

1. Test 10 replicates of negative and positive by using the reference materials of enterprises. The negative agreement and the positive agreement were 100%.

2. Test three different lots kits including positive and negative reference materials of enterprises. The negative results and the positive results were 100%

6. Hook Effect

The Test Card was tested up to 1.6 × 105 TCID50/ml of heat-inactivated 2019-nCoV strain and no high-dose effect was observed.

 

PRECAUTIONS

  • For in vitro diagnostic use.
  • Use appropriate precautions in the collection, handling, storage, and disposal of patient samples and used test contents.
  • Use of Nitrile, Latex (or equivalent) gloves is recommended when handling patient samples.
  • Do not reuse the used Test Card or saliva swab.
  • Should never open the foil pouch of the Test Card exposing it to the ambient environment until the Test Card is ready for immediate use.
  • Discard and do not use any damaged or dropped Test Card or material.
  • Inadequate or inappropriate sample collection, storage, and transport may yield false test results.
  • Sample collection and handling procedures require specific training and guidance.
  • To obtain accurate results, do not use visually bloody or overly viscous samples.
  • To obtain accurate results, an opened and exposed Test Card should not be used.
  • Testing should be performed in an area with adequate ventilation.
  • Wear suitable protective clothing, gloves, and eye/face protection when handling the contents of this test.
  • Wash hands thoroughly after handling.

KEY TO SYMBOLS USED

Reliable Visual COVID 19 Antigen Rapid Test Kit ISO13485 Certificate 2 Materials Included   Reliable Visual COVID 19 Antigen Rapid Test Kit ISO13485 Certificate 3 Test Cassette
Reliable Visual COVID 19 Antigen Rapid Test Kit ISO13485 Certificate 4Reliable Visual COVID 19 Antigen Rapid Test Kit ISO13485 Certificate 5 Instructions for Use   Reliable Visual COVID 19 Antigen Rapid Test Kit ISO13485 Certificate 6 Date of
Manufacturer
Reliable Visual COVID 19 Antigen Rapid Test Kit ISO13485 Certificate 7 Consult Instructions   Reliable Visual COVID 19 Antigen Rapid Test Kit ISO13485 Certificate 8 Do Not Reuse
For Use
Reliable Visual COVID 19 Antigen Rapid Test Kit ISO13485 Certificate 9 Store at 2°C~30°C   Reliable Visual COVID 19 Antigen Rapid Test Kit ISO13485 Certificate 10Reliable Visual COVID 19 Antigen Rapid Test Kit ISO13485 Certificate 11 Catalogue Number
Reliable Visual COVID 19 Antigen Rapid Test Kit ISO13485 Certificate 12Reliable Visual COVID 19 Antigen Rapid Test Kit ISO13485 Certificate 13 Expiration Date   Reliable Visual COVID 19 Antigen Rapid Test Kit ISO13485 Certificate 14 Keep away from Sunlight
Reliable Visual COVID 19 Antigen Rapid Test Kit ISO13485 Certificate 15 Manufacturer   Reliable Visual COVID 19 Antigen Rapid Test Kit ISO13485 Certificate 16Reliable Visual COVID 19 Antigen Rapid Test Kit ISO13485 Certificate 17 Tests per Kit
Reliable Visual COVID 19 Antigen Rapid Test Kit ISO13485 Certificate 18Reliable Visual COVID 19 Antigen Rapid Test Kit ISO13485 Certificate 19 Lot Number   Reliable Visual COVID 19 Antigen Rapid Test Kit ISO13485 Certificate 20Reliable Visual COVID 19 Antigen Rapid Test Kit ISO13485 Certificate 21 In Vitro Diagnostic Medical Device
Reliable Visual COVID 19 Antigen Rapid Test Kit ISO13485 Certificate 22 Keep Dry      
Reliable Visual COVID 19 Antigen Rapid Test Kit ISO13485 Certificate 23 Guangzhou Decheng Biotechnology Co., LTD
Room 218, Building 2, No.68, Nanxiang Road, Science City, Huangpu District, 510000, Guangzhou P.R.China
TEL:+86-020-82557192
service@dochekbio.com
www.dochekbio.com
 
Reliable Visual COVID 19 Antigen Rapid Test Kit ISO13485 Certificate 24 CMC Medical Devices & Drugs S.L. Reliable Visual COVID 19 Antigen Rapid Test Kit ISO13485 Certificate 25
C/ Horacio Lengo Nº 18, CP 29006,
Málaga, Spain

 

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