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Saliva Test SARS-CoV-2 Antigen IVD Kit Lollipop Whitelist CE Certification

Saliva Test SARS-CoV-2 Antigen IVD Kit Lollipop Whitelist CE Certification

MOQ: 500 test
Price: Negotiable
Standard Packaging: color packing
Delivery Period: 5-7 days
Payment Method: T/T
Supply Capacity: 500000 per day
Detail Information
Place of Origin
USA
Brand Name
REAGEN
Certification
CE,FDA,ANVISA
Model Number
RNS92048A
Temperature:
4~30℃
Accuracy:
90%-99.0%
Aging:
5-15 Min
Minimum Order Quantity:
500 test
Price:
Negotiable
Packaging Details:
color packing
Delivery Time:
5-7 days
Payment Terms:
T/T
Supply Ability:
500000 per day
High Light:

SARS-CoV-2 Antigen IVD Kit Lollipop

,

Saliva Test IVD Kit

,

CE SARS-CoV-2 Antigen IVD Kit

Product Description

SARS-CoV-2 Antigen IVD Kit Lollipop(Saliva)Whitelist CE Certification

Product Performance Index

 

Clinical verification

In order to evaluate the diagnostic performance, this study used COVID-19-positive specimens from 120 individuals and COVID-19-negative specimens from 400 individuals. These specimens were tested and confirmed by the RT-PCR method. The results are as follows:

 

Method Clinically confirmed (RT-PCR)

Total

results

Antigen test card

 

Results Positive Negative
Positive 115 6 121
Negative 5 394 399
Total 120 400 520
 

 

Sensitivity:95.83%(115/120),95%CI(90.54%,98.63%)

Specificity:98.50%(394/400),95%CI(96.76%,99.45%)

Total coincidence rate: 97.88%(509/520),95%CI(96.25%,98.94%)

 

Limitations of Inspection Methods

 

1. This product is only suitable for the detection of human saliva samples. It detects the virus content in the sample extract, regardless of whether the virus is infectious. Therefore, the test results of the same sample using this product may not be correlated with the virus culture results.

2. The test card of this product need to be restored to room temperature before use. Improper temperature may cause abnormal test result.

3. During the testing process, the test results did not match the clinical results due to insufficient saliva collection samples or improper collection and specimen extraction operations.

4. During the use of this product, you need to strictly follow the operating steps of the manual. Improper operating steps and envi-ronmental conditions may cause abnormal test results.

5. The positive test result of this product cannot distinguish between SARS-CoV and SARS-CoV-2.

6. A negative test result of this product cannot rule out the possibility of other pathogens being positive.

7. Negative test results are recommended to be verified with nucleic acid detection reagents to avoid the risk of missed test.

Saliva Test SARS-CoV-2 Antigen IVD Kit Lollipop Whitelist CE Certification 0Saliva Test SARS-CoV-2 Antigen IVD Kit Lollipop Whitelist CE Certification 1Saliva Test SARS-CoV-2 Antigen IVD Kit Lollipop Whitelist CE Certification 2

 

products
PRODUCTS DETAILS
Saliva Test SARS-CoV-2 Antigen IVD Kit Lollipop Whitelist CE Certification
MOQ: 500 test
Price: Negotiable
Standard Packaging: color packing
Delivery Period: 5-7 days
Payment Method: T/T
Supply Capacity: 500000 per day
Detail Information
Place of Origin
USA
Brand Name
REAGEN
Certification
CE,FDA,ANVISA
Model Number
RNS92048A
Temperature:
4~30℃
Accuracy:
90%-99.0%
Aging:
5-15 Min
Minimum Order Quantity:
500 test
Price:
Negotiable
Packaging Details:
color packing
Delivery Time:
5-7 days
Payment Terms:
T/T
Supply Ability:
500000 per day
High Light

SARS-CoV-2 Antigen IVD Kit Lollipop

,

Saliva Test IVD Kit

,

CE SARS-CoV-2 Antigen IVD Kit

Product Description

SARS-CoV-2 Antigen IVD Kit Lollipop(Saliva)Whitelist CE Certification

Product Performance Index

 

Clinical verification

In order to evaluate the diagnostic performance, this study used COVID-19-positive specimens from 120 individuals and COVID-19-negative specimens from 400 individuals. These specimens were tested and confirmed by the RT-PCR method. The results are as follows:

 

Method Clinically confirmed (RT-PCR)

Total

results

Antigen test card

 

Results Positive Negative
Positive 115 6 121
Negative 5 394 399
Total 120 400 520
 

 

Sensitivity:95.83%(115/120),95%CI(90.54%,98.63%)

Specificity:98.50%(394/400),95%CI(96.76%,99.45%)

Total coincidence rate: 97.88%(509/520),95%CI(96.25%,98.94%)

 

Limitations of Inspection Methods

 

1. This product is only suitable for the detection of human saliva samples. It detects the virus content in the sample extract, regardless of whether the virus is infectious. Therefore, the test results of the same sample using this product may not be correlated with the virus culture results.

2. The test card of this product need to be restored to room temperature before use. Improper temperature may cause abnormal test result.

3. During the testing process, the test results did not match the clinical results due to insufficient saliva collection samples or improper collection and specimen extraction operations.

4. During the use of this product, you need to strictly follow the operating steps of the manual. Improper operating steps and envi-ronmental conditions may cause abnormal test results.

5. The positive test result of this product cannot distinguish between SARS-CoV and SARS-CoV-2.

6. A negative test result of this product cannot rule out the possibility of other pathogens being positive.

7. Negative test results are recommended to be verified with nucleic acid detection reagents to avoid the risk of missed test.

Saliva Test SARS-CoV-2 Antigen IVD Kit Lollipop Whitelist CE Certification 0Saliva Test SARS-CoV-2 Antigen IVD Kit Lollipop Whitelist CE Certification 1Saliva Test SARS-CoV-2 Antigen IVD Kit Lollipop Whitelist CE Certification 2

 

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