• Lateral Flow Saliva Test Kit Room Temperature Easy Storage Rapid Test for home use
Lateral Flow Saliva Test Kit Room Temperature Easy Storage Rapid Test for home use

Lateral Flow Saliva Test Kit Room Temperature Easy Storage Rapid Test for home use

Product Details:

Place of Origin: China
Brand Name: Vchek

Payment & Shipping Terms:

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

Lateral Flow Saliva Test Kit Room Temperature Easy Storage

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Room Temperature Lateral Flow Saliva Test Kit Easy Storage

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Easy Storage Lateral Flow SalivaTest for home use

Product Description

Lateral Flow Saliva Test Kit Room Temperature Easy Storage

SARS-CoV-2 Saliva Antigen Rapid Test Kit is an in vitro diagnostic rapid test for the qualitative detection of SARS-CoV-2 Antigen (Ag) in human saliva specimens from individuals who meet COVID-19 clinical criteria. This SARS-CoV-2 Saliva Antigen Rapid Test Kit detects current infection during the acute phase of COVID-19, while the coronavirus is still present in large quantities in the respitory tract (nasopharynx).

 

 

COVID-19 Saliva Rapid Antigen Test is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 viral nucleoprotein antigens in Oral Fluid from individuals suspected of COVID-19 infection. Viral antigens are tested through visual interpretation of colour development. Antibodies specific to the Nucleocapsid (N) protein of SARS-CoV-2 are coated on the test line region on the membrane of the test cassette. A sample is added to the extraction reagent which is optimized to release the SARS-CoV-2 antigens from specimen. This test is intended for professional use only.

 

 

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

 

 

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

 

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

 

Lateral Flow Saliva Test Kit Room Temperature Easy Storage Rapid Test for home use 0

 

 

 
  Lateral Flow Saliva Test Kit Room Temperature Easy Storage Rapid Test for home use 1

Lateral Flow Saliva Test Kit Room Temperature Easy Storage Rapid Test for home use 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.

Lateral Flow Saliva Test Kit Room Temperature Easy Storage Rapid Test for home use 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.

 

Lateral Flow Saliva Test Kit Room Temperature Easy Storage Rapid Test for home use 4

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 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.

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 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

Lateral Flow Saliva Test Kit Room Temperature Easy Storage Rapid Test for home use 5 Materials Included   Lateral Flow Saliva Test Kit Room Temperature Easy Storage Rapid Test for home use 6 Test Cassette
Lateral Flow Saliva Test Kit Room Temperature Easy Storage Rapid Test for home use 7Lateral Flow Saliva Test Kit Room Temperature Easy Storage Rapid Test for home use 8 Instructions for Use   Lateral Flow Saliva Test Kit Room Temperature Easy Storage Rapid Test for home use 9 Date of
Manufacturer
Lateral Flow Saliva Test Kit Room Temperature Easy Storage Rapid Test for home use 10 Consult Instructions   Lateral Flow Saliva Test Kit Room Temperature Easy Storage Rapid Test for home use 11 Do Not Reuse
For Use
Lateral Flow Saliva Test Kit Room Temperature Easy Storage Rapid Test for home use 12 Store at 2°C~30°C   Lateral Flow Saliva Test Kit Room Temperature Easy Storage Rapid Test for home use 13Lateral Flow Saliva Test Kit Room Temperature Easy Storage Rapid Test for home use 14 Catalogue Number
Lateral Flow Saliva Test Kit Room Temperature Easy Storage Rapid Test for home use 15Lateral Flow Saliva Test Kit Room Temperature Easy Storage Rapid Test for home use 16 Expiration Date   Lateral Flow Saliva Test Kit Room Temperature Easy Storage Rapid Test for home use 17 Keep away from Sunlight
Lateral Flow Saliva Test Kit Room Temperature Easy Storage Rapid Test for home use 18 Manufacturer   Lateral Flow Saliva Test Kit Room Temperature Easy Storage Rapid Test for home use 19Lateral Flow Saliva Test Kit Room Temperature Easy Storage Rapid Test for home use 20 Tests per Kit
Lateral Flow Saliva Test Kit Room Temperature Easy Storage Rapid Test for home use 21Lateral Flow Saliva Test Kit Room Temperature Easy Storage Rapid Test for home use 22 Lot Number   Lateral Flow Saliva Test Kit Room Temperature Easy Storage Rapid Test for home use 23Lateral Flow Saliva Test Kit Room Temperature Easy Storage Rapid Test for home use 24 In Vitro Diagnostic Medical Device
Lateral Flow Saliva Test Kit Room Temperature Easy Storage Rapid Test for home use 25 Keep Dry      
Lateral Flow Saliva Test Kit Room Temperature Easy Storage Rapid Test for home use 26 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
 
Lateral Flow Saliva Test Kit Room Temperature Easy Storage Rapid Test for home use 27 CMC Medical Devices & Drugs S.L. Lateral Flow Saliva Test Kit Room Temperature Easy Storage Rapid Test for home use 28
C/ Horacio Lengo Nº 18, CP 29006,
Málaga, Spain
 

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