• Home Use COVID 19 Rapid Ag Test Kit , Rapid Test Kit Antigen OEM ODM Service
  • Home Use COVID 19 Rapid Ag Test Kit , Rapid Test Kit Antigen OEM ODM Service
Home Use COVID 19 Rapid Ag Test Kit , Rapid Test Kit Antigen OEM ODM Service

Home Use COVID 19 Rapid Ag Test Kit , Rapid Test Kit Antigen OEM ODM Service

Product Details:

Place of Origin: China
Brand Name: Vchek

Payment & Shipping Terms:

Minimum Order Quantity: negotiable
Price: negotiable
Packaging Details: 1/5/20test 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: Saliva Antigen Rapid Test Kit
Storage:: Room Temperature Accuracy:: 99.9%
Using:: Self Test Detection: Nucleocapsid Protein Antigen From 2019 NCoV
High Light:

Home Use COVID 19 Rapid Ag Test Kit OEM ODM Service

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OEM ODM Home Use COVID 19 Rapid Ag Test Kit

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OEM ODM Service COVID 19 Rapid Ag Test Kit

Product Description

Home Use COVID 19 Rapid Ag Test Kit OEM ODM Service

Key Benefits:

• First and the only no-spit test dedicated to COVID-19 – Its sponge-like pen tip will collect a sufficient volume of specimen in 2 mins without the need to spit and avoiding uncomfortable nasal/throat swabbing.
• ALL IN ONE – No need to waste time setting up a workstation and handle numerous assay components. All you need is one pen that can be used comfortably in any location.

 

 

Test Principle


Anti-SARS-CoV-2 antibodies are immobilized on the test region of the nitrocellulose membrane. Anti-SARS-CoV-2 antibodies conjugated to coloured particles are immobilized on the conjugated pad. A sample is added to the extraction buffer which is optimized to release the SARS-CoV-2 antigens from specimen. During testing, target antigens, if present in the saliva samples, will be released into the extraction buffer individually packed in the kit. Consequently, the extracted antigens will bind to anti-SARS-CoV-2 antibodies conjugated to coloured particles.

 

PRINCIPLE OF THE TEST

This test uses double-antibody sandwich to legally detect the antigen of novel coronavirus (2019-nCoV) in saliva samples. During detection, the gold labeled anti-2019-nCoV monoclonal antibody in the labeling pad binds to the 2019-nCoV antigen in the sample to form a complex, and the reaction complex moves forward along the nitrocellulose membrane under the action of chromatography, it is captured by the anti-2019-nCoV monoclonal antibody pre-coated by the detection zone (T) on the nitrocellulose membrane, and finally a red color reaction line is formed in the T zone. If the sample does not contain 2019-nCoV antigen, a red color reaction line cannot be formed in the T zone. Regardless of whether the sample to be tested contains 2019-nCoV antigen, a red reaction line will always form in the quality control area (C).

 

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.

 

Sample Processing:

  • Take out the buffer tube, open the dripper cap.
  • Gently turn the saliva collector and tighten it onto the buffer tube.
  • Spit saliva into the oval mouth of the saliva collector,make the saliva flow into the tube completely until to 1000uL marker line.
  • Remove the saliva collector.
  • Close the dripper cup and tighten it.
  • Shake the tube at least 10 times, make sure the saliva mixes well with sample buffer.
  • Break the dripper head

Home Use COVID 19 Rapid Ag Test Kit , Rapid Test Kit Antigen OEM ODM Service 0

 

 

 
  Home Use COVID 19 Rapid Ag Test Kit , Rapid Test Kit Antigen OEM ODM Service 1

Home Use COVID 19 Rapid Ag Test Kit , Rapid Test Kit Antigen OEM ODM Service 2

 

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

 

 

 

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.

 

Home Use COVID 19 Rapid Ag Test Kit , Rapid Test Kit Antigen OEM ODM Service 3

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 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.


4. Interference Substances

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

 

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

Home Use COVID 19 Rapid Ag Test Kit , Rapid Test Kit Antigen OEM ODM Service 4 Materials Included   Home Use COVID 19 Rapid Ag Test Kit , Rapid Test Kit Antigen OEM ODM Service 5 Test Cassette
Home Use COVID 19 Rapid Ag Test Kit , Rapid Test Kit Antigen OEM ODM Service 6Home Use COVID 19 Rapid Ag Test Kit , Rapid Test Kit Antigen OEM ODM Service 7 Instructions for Use   Home Use COVID 19 Rapid Ag Test Kit , Rapid Test Kit Antigen OEM ODM Service 8 Date of
Manufacturer
Home Use COVID 19 Rapid Ag Test Kit , Rapid Test Kit Antigen OEM ODM Service 9 Consult Instructions   Home Use COVID 19 Rapid Ag Test Kit , Rapid Test Kit Antigen OEM ODM Service 10 Do Not Reuse
For Use
Home Use COVID 19 Rapid Ag Test Kit , Rapid Test Kit Antigen OEM ODM Service 11 Store at 2°C~30°C   Home Use COVID 19 Rapid Ag Test Kit , Rapid Test Kit Antigen OEM ODM Service 12Home Use COVID 19 Rapid Ag Test Kit , Rapid Test Kit Antigen OEM ODM Service 13 Catalogue Number
Home Use COVID 19 Rapid Ag Test Kit , Rapid Test Kit Antigen OEM ODM Service 14Home Use COVID 19 Rapid Ag Test Kit , Rapid Test Kit Antigen OEM ODM Service 15 Expiration Date   Home Use COVID 19 Rapid Ag Test Kit , Rapid Test Kit Antigen OEM ODM Service 16 Keep away from Sunlight
Home Use COVID 19 Rapid Ag Test Kit , Rapid Test Kit Antigen OEM ODM Service 17 Manufacturer   Home Use COVID 19 Rapid Ag Test Kit , Rapid Test Kit Antigen OEM ODM Service 18Home Use COVID 19 Rapid Ag Test Kit , Rapid Test Kit Antigen OEM ODM Service 19 Tests per Kit
Home Use COVID 19 Rapid Ag Test Kit , Rapid Test Kit Antigen OEM ODM Service 20Home Use COVID 19 Rapid Ag Test Kit , Rapid Test Kit Antigen OEM ODM Service 21 Lot Number   Home Use COVID 19 Rapid Ag Test Kit , Rapid Test Kit Antigen OEM ODM Service 22Home Use COVID 19 Rapid Ag Test Kit , Rapid Test Kit Antigen OEM ODM Service 23 In Vitro Diagnostic Medical Device
Home Use COVID 19 Rapid Ag Test Kit , Rapid Test Kit Antigen OEM ODM Service 24 Keep Dry      
Home Use COVID 19 Rapid Ag Test Kit , Rapid Test Kit Antigen OEM ODM Service 25 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
 
Home Use COVID 19 Rapid Ag Test Kit , Rapid Test Kit Antigen OEM ODM Service 26 CMC Medical Devices & Drugs S.L. Home Use COVID 19 Rapid Ag Test Kit , Rapid Test Kit Antigen OEM ODM Service 27
C/ Horacio Lengo Nº 18, CP 29006,
Málaga, Spain

 

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