Sarscov2 Antigen Rapid Test (POCT)

• Customization: Available
• Type: Detection Card
• Syringe: None
• Model NO.: HCOV016GP
• 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 SARSCoV2 Antigen Rapid Test (POCT) is a rapid chromatographic immunoassay for the qualitative detection of novel coronavirus  in human nasopharyngeal, oropharyngeal and nasal 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 SARSCoV2 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 SARSCoV2 Antigen Rapid Test (POCT) has been compared with a commercial gold standard reagent (PCR). The result showed the relative sensitivity and specificity

1. Nasopharyngeal swab 

Method		Gold standard reagent (PCR)		Total Results
SARSCoV2 Antigen Rapid Test (POCT)	Results	Positive	Negative
	Positive	115	0	115
	Negative	2	200	202
Total Result		117	200	317

Relative Sensitivity: 98.29% (95%CI: 93.60%~99.91%)  
Relative Specificity: 100% (95%CI:97.73%~100.00%) 
Accuracy: 99.37% (95%CI:97.58%~99.98%)

1. Oropharyngeal swab

Method		Gold standard reagent (PCR)		Total Results
SARSCoV2 Antigen Rapid Test (POCT)	Results	Positive	Negative
	Positive	124	0	124
	Negative	7	200	207
Total Result		131	200	331

Relative Sensitivity: 94.66% (95%CI: 89.19%~97.58%)  
Relative Specificity: 100% (95%CI:97.73%~100.00%) 
Accuracy: 97.89% (95%CI:95.61%~99.06%)
2. Limit of Detection (LOD)
The limit of detection of the SARSCoV2 Antigen Rapid Test (POCT) has been studied. The LOD of the test to the SARSCoV2 N protein is around 100Pg/mL. The LOD of the test to the SARSCoV2 virus (inactivated) is about 1.4X10² TCID₅₀/mL.     
3. Cross-reactivity:
No cross reaction was observed to the SARSCoV2 Antigen Rapid Test (POCT) 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 SARSCoV2 Antigen Rapid Test (POCT) 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