Home ꄲ HUMAN ꄲ Healfo SARS-CoV-2 Antigen Rapid Test

Healfo SARS-CoV-2 Antigen Rapid Test

ꄲNext： Single Channel Fluorescence immunoassay analyzer

INTENDED USE

The Healfo SARS-CoV-2 Antigen Rapid Test is an in vitro immunochromatographic assay for qualitative detection of nucleocapsid protein antigen of the SARS-CoV-2 virus in nasopharyngeal (NP) swab specimens directly or after the swabs have been added to viral transport media from individuals who are suspected of COVID-19 by their healthcare provider.

It is intended to aid in the rapid diagnosis of SARS-CoV-2 infections. The Healfo SARS-CoV-2 Antigen Rapid Test does not differentiate between SARS-CoV and SARS-CoV-2.

The novel coronaviruses belong to the β genus. COVID-19 is an acute respiratory infectious disease. Entire human populations 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, dry cough, and loss of taste and smell. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases. This test is for detection of SARS-CoV-2 nucleocapsid protein antigen. Antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Rapid diagnosis of SARS-CoV-2 infection will help healthcare professionals to treat patients and control the disease more efficiently and effectively.

TEST PRINCIPLE

The Healfo SARS-CoV-2 Antigen Rapid Test is an immunochromatographic membrane assay that uses highly sensitive monoclonal antibodies to detect nucleocapsid protein from SARS-CoV-2 in nasopharyngeal (NP) swab. The test strip is composed of the following parts: namely sample pad, reagent pad, reaction membrane, and absorbing pad. The reagent pad contains the colloidal-gold conjugated with the monoclonal antibodies against the nucleocapsid protein of SARS-CoV-2; the reaction membrane contains the secondary antibodies for nucleocapsid protein of SARS-CoV-2. The whole strip is fixed inside a plastic device. When the sample is added into the sample well, conjugates dried in the reagent pad are dissolved and migrate along with the sample. If SARS-CoV-2 antigen presents in the sample, a complex formed between the anti-SARS-2 conjugate and the virus will be captured by the specific anti-SARS-2 monoclonal antibodies coated on the test line region (T). Absence of the T line suggests a negative result. To serve as a procedural control, a red line will always appear in the control line region (C) indicating that proper volume of sample has been added and membrane wicking has occurred.

MATERIAL

Material Provided:

There are three kit sizes. The kit component configurations are provided below:

Components	HF0012C	HF0012
Components	1 Test/Set	25 Test/Set
Kit Size (#of Tests)	1	25
Test Cassette (#)	1	25
Sample Diluent (#of extraction tubes)	1	25
Sample Swab	1	25
Sample Vial Rack	/	1
IFU Leaflet	1	1

*Sampel swabs may be provided separately.

Reagents and Materials Purchased Separately

A control set consisting of a positive and a negative control is provided and purchased separately from the kit. See instruction on the use of control under Quality Control.

Material Required But Not Provided：

Timer

STORAGE AND STABILITY

1. Store the Healfo SARS-CoV-2 Antigen Rapid Test at 2-30˚C.

2. If stored at 2-8˚C, ensure that the test device is brought to 15-30˚C before opening.
3. Do not freeze the kit or store the kit over 30˚C.

SPECIMEN COLLECTION AND PREPARATION

Preparation for sample collection：

Please refer to the following CDC guide on COVID-19 sample collection: https://www.cdc.gov/coronavirus/2019-ncov/lab/guidelines-clinical-specimens.html

Before collecting a sample, prepare sample extraction buffer vial as follows:

1.Label an extraction tube. Insert the test extraction tube into the tube rack provided in the kit. Make sure that the tube is standing firm and reaches the bottom of the stand.

2.open the cover of the Sample Diluent tube.

Collection of a nasopharyngeal swab specimen：

1.Carefully insert the swab into the nostril of the patient, reaching the surface of posterior nasopharynx.

2.Rotate the swab several times.

3.Withdraw the swab from the nasal cavity.

4.If a deviated septum or blockage create difficulty in obtaining the specimen from one nostril, use the same swab to obtain the specimen from the other nostril.

5.Follow “Sample Extraction from a Swab” to extract the sample.

Collection of a throat swab specimen：

1.If necessary, use a tongue suppressor to suppress tongue.

2.Insert swab into the posterior pharynx and tonsillar areas.

3.Rub swab over both tonsillar pillars and posterior oropharynx and avoid touching the tongue, teeth, and gums.

4.Follow “Sample Extraction from a Swab” to extract the sample.

Sample extraction from a swab

1.Remover the cover of the extraction tube.

2.Insert the swab into the extraction tube of the extraction buffer.

2.Roll the swab at least 6 times while pressing the head against the bottom and side of the tube.

3.Leave the swab in the extraction tube for 1 minute.

4.Squeeze the tube several times with fingers from outside of the tube to immerse the swab. Remove the swab.

5.Close the cover of the sample extraction tube. Sample mixture solution will be used as test sample.

TEST PROCEDURE

Allow the test device, test sample and buffer to equilibrate to room temperature (15-30°C) prior to testing.

1.Remove test device from the sealed pouch just prior to the testing and lay flat on work bench.

2.Remove the cover of the sample extraction tube.

3.reverse the sample extraction tube and add 4 drops (about 90 μl) of sample mixture into the sample window by squeezing the extracted solution tube.

4.Wait for the colored band(s) to appear. The result should be read in 15 minutes. Do not interpret the result after 20 minutes.

INTERPRETATION OF RESULTS

1.Valid Assay

1.1A testing is valid when the C line develops.

1.2When only the C line develops, the test result indicates the absence of SARS-CoV-2 virus antigen in the sample and hence likely no infection.

1.3When both the C and T line develop, the test result indicates the presence of SARS-CoV-2 virus antigen in the sample and hence likely infection.

2.Invalid Assay

If the C Line does not develop, the assay is invalid regardless whether the color of T line is present. Repeat the assay with a new device.

PERFORMANCE CHARACTERISTICS

Clinical Sensitivity and Specificity

The Healfo SARS-CoV-2 Antigen Rapid Test has been evaluated with specimens obtained from patients. A commercialized molecular assay was used as the reference method. The results show that the Healfo SARS-CoV-2 Antigen Rapid Test has a high overall accuracy.

Table 1: The COVID-19 Antigen Rapid Test vs PCR

Method	Results	RT-PCR		Total
		Positive	Negative
Healfo SARS COV-2 Antigen Rapid Test	Positive	67	1	68
	Negative	2	178	180
Total Results		69	179	248

Relative Sensitivity: 97.1%

Relative Specificity: 99.4%

Accuracy: 98.8%

QUALITY CONTROL

1. Internal Control: This test contains a built-in control to satisfies the quality control requirements. The C Line develops after addition of the specimen and sample diluent. If the C Line does not develop, the test is invalid, indicating that the test should be repeated.

2. Positive and Negative Control: Positive and negative controls should be tested to ensure the proper performance of the assay, particularly under the following circumstances: 1) new kits (new lot or new shipment); 2) new user; 3) new test environment (e.g., natural light vs. artificial light).; 4) abnormal storge environment (outside of 2-30°C); 5) abnormal working environment (outside of 15-30°C); 6) To investigate the cause of repeated invalid results;

WARNINGS AND PRECAUTIONS

1.This package insert must be read completely before performing the test. Failure to follow directions in insert may yield inaccurate test results.

2.Test results should be read between 15 and 20 minutes after a specimen is applied to the sample well. Results read after 20 minutes may give erroneous results.

3.Do not open the sealed pouch until you are ready to conduct the assay. Once opened, the cassettes should be used within 2 hours.

4.Do not use expired devices.

5.Bring all reagents to room temperature (15-30°C) before use.

6.Do not use the components of any other type of test kit as a substitute for the components in this kit.

7.Wear protective clothing and disposable gloves while handling the kit reagents and clinical specimens. Wash hands thoroughly after performing the test.

8.Do not smoke, drink, or eat in areas where specimens or kit reagents are being handled.

9.Dispose of all specimens and materials used to perform the test as biohazardous waste.

10.Handle the negative and positive controls in the same manner as patient specimens for operator protection.

11.Do not perform the test in a room with strong air flow, i.e. an electric fan or strong air-conditioning.

LIMITATIONS OF PROCEDURE

The etiology of respiratory infection caused by microorganisms other than SARS-CoV-2 will not be established with this test. The Healfo SARS-CoV-2 Antigen Rapid Test is capable of detecting both viable and non-viable SARS-CoV-2. The performance of the Healfo SARS-CoV-2 Antigen Rapid Test depends on antigen load and may not correlate with viral culture results performed on the same specimen.

2.Failure to follow the Test Procedure may adversely affect test performance and/or invalidate the test result.

3.If the test result is negative and clinical symptoms persist, additional testing using other clinical methods is recommended. A negative result does not at anytime rule out the presence of SARS-CoV-2 antigens in specimen, as they may be present below the minimum detection level of the test or if the sample was collected or transported improperly.

4.As with all diagnostic tests, a confirmed diagnosis should only be made by a physician after all clinical and laboratory findings have been evaluated.

5.Positive test results do not rule out co-infections with other pathogens.

6.Positive test results do not differentiate between SARS-CoV and SARS-CoV-2.

7.Negative results should be treated as presumptive and confirmed with an FDA authorized molecular assay, if necessary, for clinical management, including infection control.

INdEX of CE SYMBOLS