SARS-Cov2 Antigen Rapid Test (Nasal Swab)

• Customization: Available
• Type: Detection Card
• Syringe: None
• Model NO.: HCOV017G
• Blood Sampling Needle: None
• Breathing Pattern: None
• Animal Anesthesia Machine Control Method: None
• Assay Time: 5-10 Minutes
• Delivery Time: 3~5days After Get Payment
• Payment: T/T, Western Union, Paypal
• Customized: Accpet
• Transport Package: Carton
• Specification: 10Tests/Kit
• Trademark: PETX
• Origin: Hangzhou
• HS Code: 38220010
• Production Capacity: 5000000PCS/Year

Product Description

INTENDED USE
The SARS-CoV2 Antigen Rapid Test (Nasal Swab) is a rapid chromatographic immunoassay for the qualitative detection of novel coronavirus SARS-CoV2 in human nasal swab specimen.

MATERIALS

Materials Provided

1. Foil pouches, each contains one test cassettes, and one desiccant bag
2. Assay buffer tubes (0.5ml each) with tips
3. Disposable Sampling swabs
4. Instruction for use
5. Positive control swab and negative control swab

Materials Required But Not Provided

1. Specimen collection container
2. Timer

INTERPRETATION OF RESULTS

• Positive (+): Two colored lines appear. One colored line should always appear in the control line region (C) and another line should be in the T line region.
• *NOTE: The intensity of the color in the test line regions may vary depending on the concentration of SARS-CoV2 present in the specimen. Therefore, any shade of color in the test line region should be considered positive and recorded as such.
• Negative (-): One colored line appears in the control line region (C). No line appears in the T line region.
• Invalid: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test. If the problem persists, discontinue using the test kit immediately and contact your local distributor.

PERFORMANCE CHARACTERISTICS

1. Sensitivity, Specificity and Accuracy
The SARS-CoV2 Antigen Rapid Test (Nasal Swab) has been compared with a commercial gold standard reagent (PCR). The result showed the relative sensitivity and specificity

Method		Gold standard reagent (PCR)		Total Results
SARS-CoV2 Antigen Rapid Test	Results	Positive	Negative
	Positive	103	0	103
	Negative	7	100	107
Total Result		110	100	210

Relative Sensitivity: 93.64% (95%CI: 87.23%~97.10%)  
Relative Specificity: 100% (95%CI:95.56%~100.00%) 
Accuracy: 96.67% (95%CI:93.15%~98.51%)
2. Limit of Detection (LOD)
The limit of detection of the SARS-CoV2 Antigen Rapid Test (Nasal Swab) has been studied. The LOD of the test to the SARS-CoV2 N protein is around 100Pg/mL. The LOD of the test to the SARS-CoV2 virus (inactivated) is about 1.4X10² TCID₅₀/mL.     
3. Cross-reactivity:
No cross reaction was observed to the SARS-CoV2 Antigen Rapid Test (Nasal Swab) when samples enriched with the following respiratory symptoms relative pathogens.  

Substance	Concentration	Result
Coronavirus HCoV-229E	1X10^6TCID50/mL	positive
Coronavirus HCoV-HKU1	1X10^6TCID50/mL	negative
Coronavirus HCoV-OC43	1X10^6TCID50/mL	negative
Coronavirus HCoV-NL63	1X10^6TCID50/mL	negative
Parainfluenza virus	1X10^5TCID50/mL	negative
H1N1 Influenza A virus	1X10^5TCID50/mL	negative
H3N2 influenza A virus	1X10^5TCID50/mL	negative
H7N9 influenza A virus	1X10^5TCID50/mL	negative
Influenza B virus	1X10^6TCID50/mL	negative
Mycoplasma pneumoniae	1X10^6CFU/mL	negative
Adenovirus	1X10^5TCID50/mL	negative
Respiratory syncytial virus	1X10^5TCID50/mL	negative
Enterovirus 71	1X10^5TCID50/mL	negative
Mumps virus	1X10^5TCID50/mL	negative
Measles virus	1X10^5TCID50/mL	negative
Streptococcus pneumoniae	1X10^6CFU/mL	negative
Bordetella parapertussis	1X10^6CFU/mL	negative
Mycobacterium tuberculosis	1X10^6CFU/mL	negative

4. Interfering Substances:
The following compounds and other respiratory symptoms relative virus have been tested using the SARS-CoV2 Antigen Rapid Test (Nasal Swab) and no interference was observed.

substance	concentration	result
alpha-interferon	3millionIU	No interference
Purified Mucin	1000ng/mL	No interference
Whole Blood	20μg/mL	negative
Budesonide Nasal Spray	200μL/mL	negative
	1.0mg/mL	negative
Oxymetazoline	1.0mg/mL	negative
HAMA	1.0mg/mL	negative
Fluticasone propionate	0.5mg/mL	negative