JOYSBIO SARS-CoV-2 IgG/Neutralizing antibody Rapid Test Kit Instruction Manual

: June 6, 2024
: JOYSBIO

Table of Contents

PRODUCT NAME
PACKAGE AND SPECIFICATION
INTENDED USE
TEST PRINCIPLE
COMPONENT
SPECIMEN COLLECTION AND PREPARATION
TEST METHOD
****INTERPRETATION OF TEST RESULTS
LIMITATIONS OF TEST METHOD
PERFORMANCE CHARACTERISTICS
PRECAUTIONS
BASIC INFORMATION
Documents / Resources
- Read User Manual Online (PDF format)
- Download This Manual (PDF format)

SARS-CoV-2 IgG/Neutralizing antibody Rapid Test Kit
Instruction Manual

SARS-CoV-2 IgG/Neutralizing antibody Rapid Test Kit
(Colloidal Gold)|
Instructions for Use (IFU)

PRODUCT NAME

SARS-CoV-2 IgG/Neutralizing antibody Rapid Test Kit (Colloidal Gold)

PACKAGE AND SPECIFICATION

20Tests/box (1Test ×20) 40 Tests /box (1Test ×40)

INTENDED USE

For in vitro qualitative detection of human IgG antibodies against SARS-CoV-2 and neutralizing antibodies that block the interaction between the receptor- binding domain of the viral spike glycoprotein (RBD) with the ACE2 cell surface receptor in serum, plasma, and whole blood. This test is only provided for use by clinical laboratories or to healthcare workers for point-of-care testing, and not for at-home testing. Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2, or 2019-nCoV) is an enveloped non-segmented positive-sense RNA virus. It is the cause of coronavirus disease 2019 (COVID-19), which is contagious in humans. SARS-CoV-2 has several structural proteins including spike (S), envelope (E), membrane (M) and nucleocapsid (N). The spike protein (S) contains a receptor-binding domain (RBD), which is responsible for recognizing the cell surface receptor, angiotensin-converting enzyme-2 (ACE2). It is found that the RBD of the SARS-CoV-2 S protein strongly interacts with the human ACE2 receptor leading to endocytosis into the host cells of the deep lung and viral replication. Infection with the SARS-CoV-2 initiates an immune response, which includes the production of antibodies in the blood. The secreted antibodies provide protection against future infections from viruses because they remain in the circulatory system for months to years after infection and will bind quickly and strongly to the pathogen to block cellular infiltration and replication. These antibodies are named neutralizing antibodies. For in vitro diagnostic use only. For professional use only

TEST PRINCIPLE

For the detect of human IgG antibodies against SARS-CoV-2, the Kit use the immunocapture method. For the detection of neutralizing antibodies, this Kit is a blocking rapid detection tool, which mimics the virus neutralization process. The protein-protein interaction between RBD and hACE2 can be blocked by neutralizing antibodies against SARS-CoV-2 RBD. Key components: the recombinant novel coronavirus antigen and chicken IgY labeled by colloidal gold areas tracers, the nitrocellulose membrane was coated with mouse anti- human IgG antibody, human ACE2 receptor protein (hACE2), and goat anti-chicken IgY antibody. When specimens are processed and added to the test device, neutralizing antibodies present in the specimen will bind to the RBD labeled colloidal gold and block the protein-protein interaction between RBD and hACE2. The unbound RBD labeled colloidal gold, as well as any RBD, labeled colloidal gold bound to non-neutralizing antibody will be captured on the test line (2). human IgG antibodies against SARS-CoV-2 will combine with colloidal gold-labeled novel coronavirus antigen to form a complex, which is captured by the mouse anti-human IgG antibody coated on the test line (1) form a colored band. The colloidal gold-labeled chicken IgY antibody is bound to the goat anti-chicken IgY antibody coated on the control line (C), which acts as a quality control line. The test line(2) will get weaker as the increasing concentration of the neutralizing antibodies and disappear at a high concentration of the neutralizing antibodies.

COMPONENT

Parts	20Tests/Kit	40Tests/Kit	Main components
Test Kit	20Tests/ICit (1Testx20)	40Tests/Kit
(1Test x40)	The detection line was coated with mouse anti-human IgG antibody,

STORAGE AND STABILITY

Store at 4~30ºC in the sealed pouch up to the expiration date, and the validity is tentatively 24 months. Do not freeze.
The test cassette should be used within 1 hour after taking it out from the aluminum foil bag. Sample diluent should be re-capped in time after use. 3. Keep away from sunlight, moisture, and heat.

SPECIMEN COLLECTION AND PREPARATION

The recommended samples for this kit are serum, plasma, whole blood. Plasma and whole blood can be collected by blood collection tube or centrifuge tube with EDTA-2Kor heparin sodium anticoagulant.
The samples collected with the correct medical technology should be returned to room temperature before testing. Jaundice, hemolysis, lipemia, and cloudy samples cannot be used.

Severe hemolytic or heat-inactivated specimens are not recommended. 3. Samples should be tested as soon as possible. If the test cannot be completed within 8 hours, the
samples can be stored at low temperatures. Serum and plasma can be stored for 7 days at 2-8or for 6 months at -20, and whole blood can be stored for 3 days at 2-8. Do not freeze and thaw samples repeatedly.

TEST METHOD

Bring the test kit, specimen to room temperature. Tear off the foil pouch, take out the test strip/cassette and place the test kit on a clean and level surface.
Add 20µL whole blood or 10µL serum (or plasma) into the square hole using a calibrated pipet. Then add 90 µL (3 drops) of the Sample Diluent into a circular hole. For each individual’s specimen, use
Read the test results between 25 and 30 minutes. Do not read the results after 30 minutes（When reading the results, please place the test card in the direction shown in the figure below）

****INTERPRETATION OF TEST RESULTS

IgG Positive and Neutralizing antibody Negative: Three lines appear. One colored line should be in the control line region (C), a colored line appears in IgG test line (1) region and a colored line appears in Neutralizing antibody test line (2) region which is darker or equal to Cline.
IgG Positive and Neutralizing antibody Positive: Three lines appear. One colored line should be in the control line region (C), a colored line appears in the IgG test line (1) region and a colored line appears in Neutralizing antibody test line (2) region which is lighter than Cline.
NEGATIVE: Two lines appear. One colored line should be in the control line region (C), and a colored line appears in Neutralizing antibody test line (2) region which is darker or equal to the C line.
INVALID: Control line fails to appear. Insufficient buffer volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the procedure with a new test cassette. If the problem persists, discontinue using the test kit immediately and contact your local distributor.
Result determination time: The result should be judged within 25~30 minutes after the sample is added into the sample loading well, and the result displayed after 30 minutes is invalid.

LIMITATIONS OF TEST METHOD

This product is only suitable for qualitative tests and auxiliary diagnoses.
The test results are only for clinical reference and should not be the only basis for clinical diagnosis and treatment. The clinical management of patients should be considered in combination with their symptoms, physical signs, medical history, other laboratory tests, therapeutic reactions, and epidemiological information.
The hemolytic, lipemia, jaundice, and contaminated samples may affect the test results. Such samples should be avoided.
We do not test all types of collection tubes that may be used for this kit; therefore, for blood sample collection tubes from different manufacturers, different results may be obtained due to different raw materials and additives. Each laboratory shall make its own judgment on the suitability of the blood collection tubes.

PERFORMANCE CHARACTERISTICS

1. Assay Cross-Reactivity Cross-reactivity of the Kit was evaluated using serum or plasma samples (collected before August 2019) which contain antibodies to the pathogens listed below. No false positivity was found with the following:
Table 1: Cross-reactivity Results

IgM/IgG potential cross-reactant

2. Potentially Endogenous Interfering Substances Low titer COVID-19 antibody- positive serum samples and COVID-19 antibody negative serum samples were spiked with one of the following substances to specified concentrations and tested in multiple replicates. No false positivity or false negativity was found with the following:

Bilirubin Conjugated	0.3 mg/mL	Antibody (HAMA) Human Serum Albumin	50 mg/mL
Hemoglobin	8 mg/mL	Levofloxacin	200 mg/L
Human Anti-mouse	780 ng/mL	a-IFN	200 mg/L
Bilirubin Unconjugated	0.4 mg/mL	Abidol	50 mg/L
Triglycerides	15 mg/mL	Tobramycin	10 mg/L.
Cholesterol	5 mg/mL	Ribavirin	40 mg/L
Rheumatoid Factor	2000 IU/mL	Ceftriaxone	420 mg/L
Histamine hydrochloride	4 mg/L	Meropenem	210 mg/L
Oseltamivir carboxylate	1 mg/L	Human IgM	0.5 mg/mL
Zanamivir	1 mg/L	Human IgG	9 mg/mL

PRECAUTIONS

This product is only used for in vitro diagnosis, not for other purposes; do not use expired reagents.
All reagent components, samples, and various wastes should be treated as infectious agents. At the same time, this product is a one-time use product, and it should be destroyed centrally in accordance with the local infectious disposal law or laboratory regulation.
Proper specimen collection, storage, and transport are critical to the performance of this test.
Testing should be applied by professionally trained staff working in certified laboratories or clinics at which the sample(s) is taken by qualified medical personnel.
Please read the instructions carefully before operation, and follow the instructions. During use, all laboratory reagent handling precautions must be followed.
Please use fresh samples as much as possible, and avoid using samples contaminated with bacteria, hemolysis, jaundice, or excessive blood lipid.
The results of this kit are invalid after 30 minutes.
Do not use reagents beyond the stated expiration date.

WARNINGS

A negative result can occur if the titer of antibodies against the SARS-CoV-2 virus present in the specimen is below the sensitivity of the kit.
If symptoms persist and the result from the SARS-CoV-2 neutralization test is negative, it is recommended to collect a new sample from the patient a few days later and test it again.
Not for the screening of donated blood.
Do not smoke, drink, or eat in areas where specimens or kit reagents are being handled.
Dispose of all specimens and materials used to perform the test as biohazardous waste.
Handle the negative and positive controls in the same manner as patient specimens for operator protection.
Do not perform the test in a room with strong airflow, i.e. an electric fan or strong air-conditioning.

EXPLANATION OF LABELS

IVD| In Vitro Diagnostic Use| **| See Instruction for Use| REF| Catalog #
---|---|---|---|---|---
LOT**| Batch Number| | Expiry Date| | Manufacturing Date
| Do not reuse| | Store between 4-30°C| | Keep away from Sunlight
| Keep Dry| | Manufacturer| | EU Authorized
Representative
| CE Mark|

BASIC INFORMATION

JOYSBIO(Tianjin) Biotechnology Co., Ltd.
Tianjin International Joint Academy of Biotechnology& Medicine 9th floor No.220,
Dongting Road, TEDA 300457 Tianjin China
Lotus NL B.V.
Address: Koningin Julianaplein 10,le
Verd,2595AA, The Hague, Netherlands.
DATE OF APPROVAL AND AMENDMENT OF IFU: Jun-2020