• 2019-nCoV Ag Saliva Rapid Test Kit Corona Saliva Antigen High Accurate
  • 2019-nCoV Ag Saliva Rapid Test Kit Corona Saliva Antigen High Accurate
  • 2019-nCoV Ag Saliva Rapid Test Kit Corona Saliva Antigen High Accurate
2019-nCoV Ag Saliva Rapid Test Kit Corona Saliva Antigen High Accurate

2019-nCoV Ag Saliva Rapid Test Kit Corona Saliva Antigen High Accurate

Product Details:

Place of Origin: China
Brand Name: Vchek
Certification: CE
Model Number: 0619C4

Payment & Shipping Terms:

Minimum Order Quantity: negotiable
Price: negotiable
Delivery Time: 10-15days
Payment Terms: T/T, Western Union
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:

Corona Saliva Antigen Test Kit

,

High Accurate Saliva Antigen Test Kit

Product Description

Corona Saliva Antigen Test Kit High Accurate For Diagnostic Use

Description

If you don’t like the idea of nasal or throat swabs tests, our new highly accurate Saliva tests could be the answer.

 

These lateral flow tests are accurate, fast, and comfortable to use, and more importantly, it eliminates the close contact with the examiners, reducing the risk of viral exposure.”

 

Our New COVID-19 Antigen test from dispenses with the unpleasant and sometimes painful nasopharyngeal swabs and can provide evidence of a possible COVID-19 outbreak within the office comfortably within 10minutes with only a little saliva with a gold standard specificity of 100% and a remarkable sensitivity of 94%.

 

Each Coronavirus Ag Colloidal Gold Saliva Lateral Flow Test includes all necessary reagents and requires no additional specialist equipment to conduct a successful COVID-19 test in only 10 minutes, this makes the test ideally suited for workplace testing schemes.

 

 

SUMMARY AND EXPLANATION

The novel coronaviruses belong to the β genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel coronavirus are the main source of infection; asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases.

 

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

 

 

INTENDED USE

The Test Kit is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from 2019-nCoV in saliva specimens directly collected from individuals who are suspected of COVID-19 by their healthcare provider within the first 7 days of symptom onset.

Results are for the identification of 2019-nCoV nucleocapsid protein antigen. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease.

Negative results should be treated as presumptive, and do not rule out 2019-nCoV infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions. Negative results should be considered in the context of a patient’s recent exposures, history, and the presence of clinical signs and symptoms consistent with COVID-19, and confirmed with a molecular assay, if necessary, for patient management.

The Test Kit is intended for use by trained clinical laboratory personnel specifically instructed and trained in vitro diagnostic procedures.

 

This reagent 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 kits

Specifications

 

Ingredients

0619C4X001 0619C4X005 0619C4X010 0619C4X015 0619C4X020
Cassette 1 5 10 15 20
Saliva collector 1 5 10 15 20
Buffer with tube 1 5 10 15 20
Instructions for use 1 1 1 1 1
Quick Reference Instructions NA 1 1 1 1
 

Note: The components in different batches of the kit cannot be mixed.

Materials required but not provided

  • Timer

STORAGE AND STABILITY

  • Store the Test Kit as packaged between 2-30°C.
  • The Test Kit is 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 Kit must remain in the sealed pouch until use.

SAMPLE REQUIREMENTS

  • The saliva should be gently spitted in to oval mouth of the saliva collector.
  • Do not eat, drink or smoke prior to the test for at least 30 minutes.
  • The samples should be used as soon as possible after collected.
  • Samples should not be inactivated.

TEST PROCEDURE

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

2019-nCoV Ag Saliva Rapid Test Kit Corona Saliva Antigen High Accurate 0

 

 

 
  2019-nCoV Ag Saliva Rapid Test Kit Corona Saliva Antigen High Accurate 1

2019-nCoV Ag Saliva Rapid Test Kit Corona Saliva Antigen High Accurate 2

 

Test Procedure

Before test, please read the instruction manual.

  • Take the sample buffer and test cassette to equilibrate to room temperature.
  • Unpack the aluminum foil bag, place the test cassette horizontally on the table and mark it.
  • Add 80μL (3 drops) of the processed sample to the sample well, and timed. Recommended to use a pipette to take buffer/samples to reduce deviations.
  • As the test begins to work, the purple color move across the result window in the center of the test device.
  • Wait for 10 minutes and read the results.

2019-nCoV Ag Saliva Rapid Test Kit Corona Saliva Antigen High Accurate 3

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 Kit.

LIMITATIONS

  • The result of the Test Kit 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.
  • Test Kit 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 Kit 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 Kit was established with 242 sample collected from symptomatic patients, who with symptoms onset within 7 days.

Sensitivity: 95.04% (115/121), 95% CI (89.60,97.71)

Specificity: 98.54% (135/137), 95% CI (94.83, 99.60).

2019-nCoV Ag Saliva Rapid Test Kit (Immunochromatography) Comparative RT-PCR Test Result
Positive (+) Negative (-) Total
Detected Positive 115 2 117
Detected Negative 6 135 141
Total 121 137 258

The performance of Test Kit with positive results stratified by the comparative method cycle threshold (Ct) counts were collected and assessed to better understand the correlation of assay performance to the cycle threshold, As presented in the table below, the positive agreement of the Test Kit is higher with samples of a Ct count <25.

2019-nCoV Ag Saliva Rapid Test Kit (Immunochromatography)

Comparative RT-PCR

Method

(Positive by Ct Value)

Positive (Ct<=25)

Positive

(Ct>25)

Detected Positive 95 20
Total 96 25
Positive agreement 98.95% 80.00%

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 Kit is 100 TCID50/mL

  • Cross-reactivity


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 Kit 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 kit or saliva collector.
  • Should never open the foil pouch of the Test Kit exposing it to the ambient environment until the Test Kit is ready for immediate use.
  • Discard and do not use any damaged or dropped Test Kit 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 Kit 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

2019-nCoV Ag Saliva Rapid Test Kit Corona Saliva Antigen High Accurate 4 Materials Included   2019-nCoV Ag Saliva Rapid Test Kit Corona Saliva Antigen High Accurate 5 Test Card  
2019-nCoV Ag Saliva Rapid Test Kit Corona Saliva Antigen High Accurate 6 Instructions for Use   2019-nCoV Ag Saliva Rapid Test Kit Corona Saliva Antigen High Accurate 7 Saliva Collector  
2019-nCoV Ag Saliva Rapid Test Kit Corona Saliva Antigen High Accurate 8

Consult Instructions

For Use

  2019-nCoV Ag Saliva Rapid Test Kit Corona Saliva Antigen High Accurate 9

Date of

Manufacturer

 
2019-nCoV Ag Saliva Rapid Test Kit Corona Saliva Antigen High Accurate 10 Store at 2°C~30°C   2019-nCoV Ag Saliva Rapid Test Kit Corona Saliva Antigen High Accurate 11 Do Not Reuse  
2019-nCoV Ag Saliva Rapid Test Kit Corona Saliva Antigen High Accurate 12 Expiration Date   2019-nCoV Ag Saliva Rapid Test Kit Corona Saliva Antigen High Accurate 13 Catalogue Number  
2019-nCoV Ag Saliva Rapid Test Kit Corona Saliva Antigen High Accurate 14 Manufacturer   2019-nCoV Ag Saliva Rapid Test Kit Corona Saliva Antigen High Accurate 15 Keep away from Sunlight  
2019-nCoV Ag Saliva Rapid Test Kit Corona Saliva Antigen High Accurate 16 Lot Number   2019-nCoV Ag Saliva Rapid Test Kit Corona Saliva Antigen High Accurate 17 Tests per Kit  
2019-nCoV Ag Saliva Rapid Test Kit Corona Saliva Antigen High Accurate 18 Keep Dry   2019-nCoV Ag Saliva Rapid Test Kit Corona Saliva Antigen High Accurate 19 In Vitro Diagnostic Medical Device  

2019-nCoV Ag Saliva Rapid Test Kit Corona Saliva Antigen High Accurate 20

 

 

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

sales@dochekbio.com

www.dochekbio.com

 

 
2019-nCoV Ag Saliva Rapid Test Kit Corona Saliva Antigen High Accurate 21

CMC Medical Devices & Drugs S.L.

C/ Horacio Lengo Nº 18, CP 29006,

Málaga, Spain

2019-nCoV Ag Saliva Rapid Test Kit Corona Saliva Antigen High Accurate 22

 

Doc No.: DC-IN-0619C01 Ver 1.3

Rel.:2021/01/31

 

Want to Know more details about this product
I am interested in 2019-nCoV Ag Saliva Rapid Test Kit Corona Saliva Antigen High Accurate could you send me more details such as type, size, quantity, material, etc.
Thanks!
Waiting for your reply.