GenBody COVID-19 Total Solution

Expected Use

The GenBody COVID-19 Ag is a rapid immunochromatographic diagnostic test (RDT) designed for qualitative analysis detection of SARS-CoV-2 nucleocapsid protein antigen in direct nasopharyngeal (NP) or exterior nasal (NA) swab samples from people suspected of COVID-19 by their healthcare provider within the first six days of onset of symptoms, or people without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over two to three days with at least 24 hours and no more than 48 hours between tests.

Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988. (CLIP), 42 U.S.C. §263a, which meet the requirements for tests of moderate, high, or exempt complexity. The product is licensed for use at the point of care (POC), that is, inpatient care settings operating under a CLIA. Certificate of Waiver, Certificate of Compliance or Certificate of Accreditation.

The results are for the identification of the SARS-CoV-2 nucleocapsid antigen. The antigen is generally detectable in Nasopharyngeal (PN) or anterior nasal (AN) swab samples during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with the patient’s history and other diagnostic information is necessary to determine the status of the infection. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definitive cause of the disease. Laboratories inside the United States and its territories must report all results to the appropriate public health authorities.

Negative results should be treated as presumptive and can be confirmed with a molecular assay, if necessary for patient management. Negative results do not rule out SARS-CoV-2 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 compatible with COVID-19.

Explanation Of The Test

COVID-19 (short for “Coronavirus Disease 2019”) is a disease recognized for the first time in 2019 that is caused by a type of new coronavirus called SARS-CoV-2. Due to its rapid spread, the World Health Organization (WHO) recognized the disease as a global pandemic on March 11, 2020. People infected with SARS-CoV-2 can have a variety of symptoms ranging from asymptomatic infection to severe respiratory illness and even death. The virus is mainly transmitted from person to person through respiratory particles, even by people without symptoms.

The GenBody COVID-19 Ag Test is a rapid and qualitative immunochromatographic assay for the determination of the presence of SARS-CoV-2 antigens in human nasopharyngeal or anterior nasal swab specimens. The test strip Each device contains mouse monoclonal antibodies against the SARS-CoV-2 nucleocapsid protein (NP). When the sample contains SARS-CoV-2 antigens, anti-SARS-CoV-2 monoclonal antibodies that are colloidal coupled gold binds to SARS-CoV-2 antigens in the sample to form an antigen-antibody complex. This complex is then captured by immobilized anti-SARS-CoV-2 monoclonal antibodies on the test line, and a visible line appears in the membrane, while unbound dye complexes continue to migrate beyond the test line area.

Internal quality control

Each GenBody COVID-19 Agriculture Test Device has a built-in internal procedural control. The reddish-purple line appearing in position “C” is internal procedural control. This procedural control line indicates that sufficient flow has occurred and the functional integrity of the test device has been maintained. A different reddish-purple control line should always appear if the test was successful. If the control line does not appear, the test result is invalid and a new test must be performed.

External quality control

Good laboratory practice includes the use of external controls to ensure proper kit performance. Using the external controls provided in the kit, it is recommended that external control tests be performed with each new operator and before using a new lot or shipment of GenBody COVID-19 Ag kits to confirm the expected Quality control (QC) results. The frequency of additional quality control testing should be determined according to your laboratory standard quality control procedures and local, state, and federal regulations or accreditation requirements.

After confirmation of the expected results, the kit is ready for use with patient samples. The GenBody COVID19 Ag Kit contains two control swabs. Test control swabs in the same way as patient samples. When positive control is tested, reddish-purple lines appear at positions C and T.

Test Procedures

Procedural Notes

• Allow test devices, reagents, samples, and/or controls to equilibrate to room temperature (15 ~ 30 ° C) before the test.
• Do not open the foil pouch until one is ready to test.
• Label the device with the identification of the patient or control to be tested.
• Place the test device on a level surface.
• Used specimens, swabs, tubes, and test devices should be treated as biohazard waste.

Results Analysis

1) Positive result: Two reddish-purple lines appear in the test window, one at the position of the test line (T) and the other at the position of the control line (C).

Note: The test line (reddish-violet line) may vary in hue and intensity (light or dark, weak or strong) depending on the concentration of antigen detected. The intensity of the control line should not be compared to that of the test line for the interpretation of the test result. Any slight reddish-purple visible in the test line should be interpreted as positive.

Note: Additional confirmatory testing with a molecular test may also be required for positive results if there is a low probability of SARS-CoV-2 infection, such as in people with no known exposure to SARS-CoV-2 or who reside in communities with a low prevalence of infection.

2. Negative result: only a reddish-purple line appears at the position of the control line (C) with no line in the test line position (T).

Note: If the first test result is negative for people without symptoms, people should be retested with a second test after 24 hours, but no more than 48 hours. Negative results should be treated as presumptive and confirmed with a molecular assay, if necessary, for patient management.

Note: For serial testing programs, additional confirmatory testing with a molecular test for negative results may be necessary after the second negative result for asymptomatic patients if there is a high probability of SARS-CoV-2 infection, such as in an individual with close contact with COVID-19 or with suspected exposure to COVID-19 or in communities with a high prevalence of infection.

3) Invalid Result: If a line does not appear at the control line position (C) within 15 minutes, the test result is invalid. Retest with a new Ag GenBody COVID-19 Test Device.

Storage And Stability

• The GenBody COVID-19 Ag Kit should be stored between 2 and 30 ° C (35.6 to 86 ° F).
• The kit components in the GenBody COVID-19 Ag Kit are stable until the expiration date printed on the label.
• The test device should remain in the sealed foil pouch until use.

Warnings And Precautions

1) For in vitro diagnostic use only.
2) This product has not been cleared or approved by the FDA; but it has been cleared by the FDA under a EUA for use by laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform tests of moderate, high or exempt complexity. This product is licensed for use in the Point of Care (POC), that is, inpatient care settings operating under a CLIA Certificate of Waiver, Certified of Compliance or Certificate of Accreditation.
3) Federal law restricts the sale of this device to or on the order of a licensed physician (the US only).
4) This product has been authorized only for the detection of SARS-CoV-2 proteins, not for any other viruses or pathogens.
5) The emergency use of this product is only authorized for the duration of the declaration that the circumstances exist that justifies the authorization of the emergency use of in vitro diagnostics for the detection and/or diagnosis of COVID-19 under Section 564 (b) (1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3 (b) (1) unless the statement is finalized or the authorization is revoked earlier.
6) Laboratories within the United States and its territories must report all results to the public health laboratories.

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