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NINGBO LVTANG BIOTECHNOLOGY CO., LTD.
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NINGBO LVTANG BIOTECHNOLOGY CO., LTD.

Zhejiang,China

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NINGBO LVTANG BIOTECHNOLOGY CO., LTD.

Zhejiang,China

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NINGBO LVTANG BIOTECHNOLOGY CO., LTD.
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NINGBO LVTANG BIOTECHNOLOGY CO., LTD.

Zhejiang,China

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SARS-CoV-2 /Influenza A+B Antigen Detection Kit(Lateral Flow Method)

FOB Price : Get a Price/Quote

Min.Order : 1000 Piece(s)

Certification : CE

Brand Name : TWIZUK

Payment Terms : T/T

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product information

  • brand name : TWIZUK

  • certification : CE

  • min.order : 1000 Piece(s)

  • warranty : \

  • payment terms : T/T

  • Packaging : 1 Test/Box, 5Tests/Box, 25Tests/Box

  • Specification : \

  • place of origin : Zhejiang

product description

Advantage
The test kit for layperson use by NINGBO LVTANG BIOTECHNOLOGY CO.,LTD. can be used for the qualitative, presumptive detection of influenza A and B viral antigens and SARS-CoV-2 antigen from nasal swab specimens with high sensitivity and specificity.
Intended Use
SARS-CoV-2/Influenza A+B Antigen Detection Kit (Colloidal Gold Method) is a rapid visual immunoassay for the qualitative, presumptive detection of influenza A and B viral antigens and SARS-CoV-2 antigen from nasal swab specimens. 
This test kit is for in vitro diagnostic use only. It's intended for layperson use and for people age 7 years or above, children 7-14 years of age should be tested by an adult (over 18 years old). People over 65 years of age should seek help with the test. This product is designed to be used at home or similar environment by a layperson as an aid in the rapid differential diagnosis of acute influenza type A and type B virus and SARS-CoV-2 infection. It only provides a presumptive screening test result for the influenza type A and type B virus and SARS-CoV-2 virus. It is required that patients confirmed positive result to contact their State or Territory Coronavirus testing services and request a laboratory PCR test. A negative result cannot be fully relied on to determine the tested patient is influenza type A and type B virus and SARS-CoV-2 free. Should the patients have symptoms be requested a laboratory PCR test and follow the medical advice.

Sensitivity, Specificity and Accuracy
SARS-CoV-2
A total of 665 various types of samples are tested. Compared with the COVID-19 Coronavirus Real Time PCR Kit (RT-PCR), the SARS-CoV-2/Influenza A+B Antigen Detection Kit  (Colloidal Gold Method) (See below Table for details)

Clinical sample		 COVID-19 Coronavirus Real Time PCR Kit (RT-PCR)
Total
Positive Negative
SARS-CoV-2/Influenza A+B Antigen Detection Kit (N line)  

 (Colloidal Gold Method)		 Positive 145 0 145
Negative 3 517 520
Total 148 517 665

Sensitivity:97.97% (95% CI: 94.19%-99.58%) 
Specificity:100% (95% CI: 98.67%-100.00%)
Accuracy:99.46% (95% CI:98.43%-99.89%)

Influenza A
A total of 665 various types of samples are tested. Compared with the  cobas® Liat® Influenza A/B & RSV Assay(RT-PCR), the SARS-CoV-2/Influenza A+B Antigen Detection Kit  (Colloidal Gold Method) (See below Table for details)
 

Clinical sample		  cobas® Liat® Influenza A/B & RSV Assay(RT-PCR)
Total
Positive Negative
SARS-CoV-2/Influenza A+B Antigen Detection Kit  (A line) 
 		 Positive 155 0 155
Negative 4 506 510
Total 159 506 665
 
Sensitivity:97.48% (95% CI:93.68%-99.31%) 
Specificity:100% (95% CI: 99.27%-100.00%)
Accuracy: 99.40% (95% CI:98.47%-99.84%)

Influenza B
A total of 665 various types of samples are tested. Compared with the cobas® Liat® Influenza A/B & RSV Assay(RT-PCR), the SARS-CoV-2/Influenza A+B Antigen Detection Kit  (Colloidal Gold Method) (See below Table for details)

Clinical sample		  cobas® Liat® Influenza A/B & RSV Assay(RT-PCR)
Total
Positive Negative
SARS-CoV-2/Influenza A+B Antigen Detection Kit  (B line)
 		 Positive 144 1 145
Negative 5 515 520
Total 149 516 665
 
Sensitivity:96.64% (95% CI:92.34%-98.90%) 
Specificity:99.81% (95% CI: 98.92%-100.00%)
Accuracy: 99.10% (95% CI:98.05%-99.67%)

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NINGBO LVTANG BIOTECHNOLOGY CO., LTD.

Ordinary verified

Business Type Manufacturer

Country / Region Zhejiang,China

Main Products General Examination Instruments, Disposable medical consumables, In vitro Diagnosis Consumables, In vitro Diagnosis Reagents, Blood Diagnosis Reagents, Immune Diagnostic Reagents, Biochemical Diagnostic Reagents, POCT Diagnostic Reagents, Medical Design & Manufacturing Products, Others

Main Markets EasternEurope,EasternAsia,WesternEurope

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SARS-CoV-2 /Influenza A+B Antigen Detection Kit(Lateral Flow Method)
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product information

product description

Advantage
The test kit for layperson use by NINGBO LVTANG BIOTECHNOLOGY CO.,LTD. can be used for the qualitative, presumptive detection of influenza A and B viral antigens and SARS-CoV-2 antigen from nasal swab specimens with high sensitivity and specificity.
Intended Use
SARS-CoV-2/Influenza A+B Antigen Detection Kit (Colloidal Gold Method) is a rapid visual immunoassay for the qualitative, presumptive detection of influenza A and B viral antigens and SARS-CoV-2 antigen from nasal swab specimens. 
This test kit is for in vitro diagnostic use only. It's intended for layperson use and for people age 7 years or above, children 7-14 years of age should be tested by an adult (over 18 years old). People over 65 years of age should seek help with the test. This product is designed to be used at home or similar environment by a layperson as an aid in the rapid differential diagnosis of acute influenza type A and type B virus and SARS-CoV-2 infection. It only provides a presumptive screening test result for the influenza type A and type B virus and SARS-CoV-2 virus. It is required that patients confirmed positive result to contact their State or Territory Coronavirus testing services and request a laboratory PCR test. A negative result cannot be fully relied on to determine the tested patient is influenza type A and type B virus and SARS-CoV-2 free. Should the patients have symptoms be requested a laboratory PCR test and follow the medical advice.

Sensitivity, Specificity and Accuracy
SARS-CoV-2
A total of 665 various types of samples are tested. Compared with the COVID-19 Coronavirus Real Time PCR Kit (RT-PCR), the SARS-CoV-2/Influenza A+B Antigen Detection Kit  (Colloidal Gold Method) (See below Table for details)

Clinical sample		 COVID-19 Coronavirus Real Time PCR Kit (RT-PCR)
Total
Positive Negative
SARS-CoV-2/Influenza A+B Antigen Detection Kit (N line)  

 (Colloidal Gold Method)		 Positive 145 0 145
Negative 3 517 520
Total 148 517 665

Sensitivity:97.97% (95% CI: 94.19%-99.58%) 
Specificity:100% (95% CI: 98.67%-100.00%)
Accuracy:99.46% (95% CI:98.43%-99.89%)

Influenza A
A total of 665 various types of samples are tested. Compared with the  cobas® Liat® Influenza A/B & RSV Assay(RT-PCR), the SARS-CoV-2/Influenza A+B Antigen Detection Kit  (Colloidal Gold Method) (See below Table for details)
 

Clinical sample		  cobas® Liat® Influenza A/B & RSV Assay(RT-PCR)
Total
Positive Negative
SARS-CoV-2/Influenza A+B Antigen Detection Kit  (A line) 
 		 Positive 155 0 155
Negative 4 506 510
Total 159 506 665
 
Sensitivity:97.48% (95% CI:93.68%-99.31%) 
Specificity:100% (95% CI: 99.27%-100.00%)
Accuracy: 99.40% (95% CI:98.47%-99.84%)

Influenza B
A total of 665 various types of samples are tested. Compared with the cobas® Liat® Influenza A/B & RSV Assay(RT-PCR), the SARS-CoV-2/Influenza A+B Antigen Detection Kit  (Colloidal Gold Method) (See below Table for details)

Clinical sample		  cobas® Liat® Influenza A/B & RSV Assay(RT-PCR)
Total
Positive Negative
SARS-CoV-2/Influenza A+B Antigen Detection Kit  (B line)
 		 Positive 144 1 145
Negative 5 515 520
Total 149 516 665
 
Sensitivity:96.64% (95% CI:92.34%-98.90%) 
Specificity:99.81% (95% CI: 98.92%-100.00%)
Accuracy: 99.10% (95% CI:98.05%-99.67%)
NINGBO LVTANG BIOTECHNOLOGY CO., LTD.
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