Healfo SARS-CoV-2 Ag Saliva Rapid Test

The Test Card is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from 2019-nCoV in saliva specimens directly collected from individuals who are suspected of COVID-19 by their healthcare provider within the first 7 days of symptom onset.

Results are for the identification of 2019-nCoV nucleocapsid protein antigen. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status Positive results do not rule out bacterial infection or co-infection with other viruses the agent detected may not be the definite cause of disease.

Negative results should be treated as presumptive, and do not rule out 2019-nCoV infection and should not be used as the sole basis for treatment or patient management decisions. including infection control decisions. Negative results should be considered in the context of a patient's recent exposures, history, and the presence of clinical signs and symptoms consistent with COVID-19, and confirmed with a molecular assay, if necessary, for patient management. The Test Card is intended for use by trained clinical laboratory personnel specifically instructed and trained in vitro diagnostic procedures.

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.

This Card uses double-antibody sandwich to legally detect the antigen of novel coronavirus (2019-nCoV) in saliva samples. 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 Provided:

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

Components	HF0015C	HF0015
	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
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  

1. Store the test card as packaged between 2-30°C.

2. The Test Card is stable until the expiration date printed on the outer packing, the product will be expired after 24 months.

3. Do not use beyond the expiration date.

4. Do not freeze any contents of the test.5. The test card must remain in the sealed pouch until use.

 

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

1. Insert the sponge end of the saliva swab into mouth. Actively swab the inside of the mouth and tongue to collect oral fluid for 90 seconds.

2. Remove the saliva swab from the mouth when the sponge become fully saturated and the inductor turn blue.

3. Do not eat or drink any things for 2 hours before the test

4. The samples should be used as soon as possible after collected.5. Samples should not be inactivated.

NOTE:

1.When sampling, gently hold it in mouth and let saliva naturally adsorb on the sponge.

2.Don't press the sponge with tongue and don't bite the sponge with teeth.

3.Any saliva specimen is appropriate for testing but the saliva specimen collected in the morning, before mouth rinsed, eating or drinking, is recommended.

Before test, please read the instructions carefully.

1. Take the test card to equilibrate to room temperature.

2. Unpack the aluminum foil bag, place the test card horizontally on the table and mark it.

3. Insert the saliva swab into the test card holder and push down saliva swab. The bump at the end of the saliva swab must be into the hole of the test card holder.

4. As the test begins to work, the purple color move across the result window in the center of the test device.

5. Wait for 15 minutes and read the results.

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

This product can only perform qualitative analysis on the detection object.

Positive Result:

If both C and T lines are visible within 10 minutes, the test result is positive and valid.

Note: Specimens containing very low levels of target antibodies may develop two colored lines over 10 minutes.

Negative Result:

If test area (T line) has no color and the control area displays a colored line, the result is negative and valid.

Invalid Result:

The test result is invalid if a colored line does not form in the control region. The sample must be re-tested, using a new test card.

 

1.Clinical Verification

The performance of Test Card was established with 243 sample collected from symptomatic patients, who with symptoms onset within 7 days.

Method	Results	Comparative RT-PCR		Total
		Positive	Negative
Healfo SARS-CoV-2 Antigen Rapid Test	Positive	110	2	112
	Negative	5	126	131
Total Results		115	128	243

Relative Sensitivity: 95.65%，95CI（90.22，98.13）

Relative Specificity: 98.44%，95CI（94.48，99.57）

Accuracy: 97.12%，95CI（94.17，98.60）

The performance of Test Card with positive results stratified by the comparative method cycle threshold (Ct) counts were collected and assessed to better understand the correlation of assay performance to the cvcle threshold. As presentec in the table below, the positive agreement of the Test Card is higher with samples of a Ct count <25.

Healfo SARS-CoV-2 Antigen Rapid Test	Comparative RT-PCR（positive by Ct Value）
	Positive>25(Ct<=25)	Positive（Ct>25）
Detection Positive	91	19
Total	92	23
Positive Agreement	98.91%	82.60%

2. Limit of Detection

The experimental results show that for the virus culture concentration above 100 TCID50/mL, the positive rate of detection is greater than or equal to 95%. For the virus culture concentration of 50 TCID50/mL and below, the positive rate of detection is lower than 95%. So, the limit of detection of the Test Card is 100 TCID50/mL.

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

If the test result is negative and clinical symptoms persist, additional testing using other clinical methods is recommended. A negative result does not at any time 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.

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

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

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

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

3. Precision

Test 10 replicates of negative and positive by using the reference materials of enterprises. The negative agreement and the positive agreement were 100%.

Test three different lots kits including positive and negative reference materials of enterprises. The negative results and the positive results were 100%.

4. Hook Effect

The Test Card was tested up to 1.6 x 105 TCID/ml of heat-inactivated 2019-nCoy strain and no high-dose effect was observed.

 

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; 

 

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.

 

1. For in vitro diagnostic use

2.Use appropriate precautions in the collection, handling, storage, and disposal of patient samples and used test contents.

3 Use of Nitrile, Latex (or equivalent) gloves is recommended when handling patient samples.

4. Do not reuse the used Test Card or saliva swab.

5. Should never open the foil pouch of the Test Card exposing it to the ambient environment until the Test Card is ready for immediate use.

6. Discard and do not use any damaged or dropped Test Card or material.

7. Inadequate or inappropriate sample collection, storage, and transport may yield false test results.

8. Sample collection and handling procedures require specific training and guidance.

9. To obtain accurate results. do not use visually bloody or overly viscous samples.

10. To obtain accurate results, an opened and exposed Test Card should not be used.

11. Testing should be performed in an area with adequate ventilation.

12. Wear suitable protective clothing, gloves, and eye/face protection when handling the contents of this test.

13. Wash hands thoroughly after handling.

       Consult instructions for use                   Use by

       For in vitro diagnostic use only                Catalog #

       Store between 2-30°C                       Lot Number

        Do not reuse                             Tests per kit

        Authorized Representative

       

       Date of manufacture                        Manufacturer

 

Healvet Medtech GZ Ltd.

Add: B201, Building 2, No.6 Xinrui Road, Hi-Tech Industrial Development Zone, Guangzhou, P.R.China

Tel: +86-020-61855600 / +86-13828472609

Email: Healvet@healfo.com

CMC Medical Devices & Drugs S.L.

C/ Horacio Lengo N18, CP29006, Málaga-Spain

info@cmcmedicaldevices.com

DOC Version No.: HF0015-20210309EN