The SARS-CoV-2 Rapid Antigen Test is a lateral fl ow rapid chromatographic immunoassay for the qualitative detection of nucleocapsid antigen to SARS-CoV-2 present in human nasal samples. This test is intended for use as an aid in detection of SARS-CoV-2 infection in individuals suspected of with clinical symptoms onset within 5 days. Results are for the identification of SARS-CoV-2 nucleocapsid antigen.
Antigen is generally detectable in human nasal swab samples during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation patient history and other diagnostic information is necessary to determine infection status. Positive results do not rule out bacterial infection or coinfection 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 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 consistent and confi rmed with a molecular assay, if necessary, for patient management.
The SARS-CoV-2 Rapid Antigen Test is intended for use in laboratory or POC settings by healthcare professionals, or self-collection under the supervision of a healthcare worker. INTRODUCTION Coronaviruses can cause a variety of acute and chronic diseases.
Common signs of a person infected with a coronavirus include respiratory symptoms, fever, cough, shortness of breath, and dyspnea. In more severe cases, infection can cause pneumonia, severe acute respiratory syndrome, kidney failure, and even death. In late 2019 a new coronavirus, later named SARS-CoV-21 , was identifi ed in a cluster of pneumonia cases, and the World Health Organization described the global SARS-CoV-2 situation as pandemic on March 11, 20202 .
The disease associated with SARS-CoV-2 infection was named (COronaVIrus Disease 2019)3. PRINCIPLE OF THE TEST The SARS-CoV-2 Rapid Antigen Test has two pre-coated lines: A “C” Control line and a “T” Test line on the surface of the nitrocellulose membrane.
Both the control line and test line in the result window are not visible before applying any samples. Mouse monoclonal anti-SARS-CoV-2 antibody is coated on the test line region and mouse monoclonal anti-Chicken IgY antibody is coated on the control line region. Mouse monoclonal anti-SARS-CoV-2 antibody conjugated with color particles are used as detectors for the SARS-CoV-2 antigen device.
During the test, the SARS-CoV-2 antigen in the sample interacts with monoclonal anti-SARS-CoV-2 antibody conjugated with color particles making an antigen-antibody color particle complex. This complex migrates on the membrane via capillary action to the test line, where it is captured by the mouse monoclonal antiSARS-CoV-2 antibody. A colored test line becomes visible in the result window if SARS-CoV-2 antigens are present in the sample.
LIMITATIONS 1.
The test procedure, precautions and interpretation of results for this test must be followed strictly when testing. 2. The test should be used for the detection of SARS-CoV-2 antigen in human nasal swab samples. 3. This test cannot be used for quantifying SARS-CoV-2 antigen concentration. 4. Failure to follow the test procedure and interpretation of test results may adversely affect test performance and/or produce invalid results. 5. The immune response cannot be assessed with this test and needs other testing methods. 6.
The test result should not be used as a sole basis for treatment or patient management decisions, and should be considered in the context of the patient’s recent exposures, history and the presence of clinical signs and symptoms consistent.
A negative result may occur if the concentration of antigen in a sample is below the detection limit of the test or if the sample was collected or transported improperly. Therefore a negative test result does not eliminate the possibility of SARS-CoV-2 infection, and should be confirmed by a molecular assay, if necessary for patient management. 8.
Positive test results do not rule out co-infections with other pathogens. 9. Positive test results do not differentiate between SARS-CoV-2 and SARS-CoV. 10.
Negative test results are not intended to rule in or rule out other coronavirus infection. 11.The performance of this device has not been assessed in a population vaccinated against. 9901-NCOV-03G Roche order number 09365397043 ▪ Positive and negative controls are supplied with each kit.
Positive and negative controls should be performed as real specimens. ▪ It is recommended that positive and negative controls be run once for each new lot, once for each untrained operator, as required by test procedures in these instructions and in accordance with local, state and federal regulations or accreditation requirements. Preparing a QC 1. Check the expiry date on the foil pouch of the controls. Do not use the controls if the expiry date has passed. 2.
Open the pouch of the positive or negative control and put the positive or negative control swab into an extraction buffer tube. Stir the swab more than 5 times. 3. Remove the swab while squeezing the sides of the tube to extract the liquid from the swab. 4. Press the nozzle cap tightly onto the tube. QC procedure 1. Place the test device on a flat surface and apply 3 drops of extracted sample at a 90 degree angle to the specimen well of the test device. 2. Read the test result in 15‑30 minutes. Do not read test results after 30 minutes. It may give false results.
Result Interpretation Positive result with positive control Pass Negative result with negative control Pass Negative result with positive control Fail Positive result with negative control Fail Control line not visible Invalid. Repeat with a new test device. SPECIFIC PERFORMANCE DATA Clinical evaluation Clinical performance of the SARS-CoV-2 Rapid Antigen Test Nasal was evaluated using nasal swab samples from 696 subjects in a prospective study at a clinical center in Germany.
The study cohort included adults at high risk for SARS-CoV-2 infection according to clinical suspicion. 311 subjects underwent nasal sampling performed by healthcare professionals and 385 subjects followed instructions to obtain a nasal swab sample by themselves. Self-collection was performed under the supervision of healthcare workers without interference or assistance. Test procedures and result reading were always performed by healthcare professionals.
RT-PCR tests (Roche cobas® SARS-CoV-2 and TibMolbiol SARS-CoV-2 E-gene assay) using combined nasopharyngeal/oropharyngeal swab samples were used as the comparator methods. Nasal sampling always preceded the combined NP/OP sampling. The following tables summarize the patient and performance characteristics of the SARS-CoV-2 Rapid Antigen Test Nasal.
The relative sensitivity was 89.6 % (Ct value ≤ 30; 95 % CI: 79.7 % - 95.7 %) for professionally collected samples, and 89.1 % (Ct value ≤ 30; 95 % CI: 78.8 % - 95.5 %) for self-collected samples. For patients for whom days post symptom onset was known, and was 0-5 days, the relative sensitivity in comparison to RT-PCR was 86.7 % (95 % CI: 75.4 % - 94.1 %) for professionally collected nasal samples and 88.9 %(95 % CI: 77.4 % - 95.8 %) for self-collected nasal samples.
The relative specificity in comparison to RT-PCR was 99.1 % (95 % CI: 96.9 % -99.9 %) for professionally collected nasal samples and 99.0 % (95% CI: 97.2 % -99.8 %) for self-collected nasal samples. In total, nasal swab samples from 150 PCR-positive and 546 PCR-negative individuals were evaluated using the SARS-CoV-2 Rapid Antigen Test Nasal. The relative sensitivity and relative specificity were 82.7 % (95 % CI: 75.6 % - 88.4 %) and 99.1 % (95 % CI: 97.9 % - 99.7 %), respectively.
Clinical Performance of the ROCHE Rapid Test:
Sensitivity: 96.52%.
Specificity: 99.86%.
It is suggested not only in high prevalence situations, but also where the prevalence is low (the most critical situation), since the performance is far above the limits indicated in the circular of the Ministry and it is therefore one of is the testing ECDC proposes with 'performance closer to RT-PCR'.
Valid for travel to other EU countries
The Roche Rapid Pap smear is included in the European Community Rapid Test List as a valid test for travel within the EU.
Sensitive to variants
The test was also performed on samples of the South African, English, Indian and Brazilian variants, with positive results (see brochure in the download section of the product sheet).
Roche Rapid Smear Specifications
- Type of test: qualitative
- Sample Type: Nasopharyngeal
- Result time: 15 min (time window 15-30 min)
- Storage Temperature: 2-30 C / 36-86 F
- Test stability (open package): 1 hour after opening the test package
- Control: Positive and negative controls are optional components.
Kit contents
- The kit is ready to use and contains all the materials needed to perform the test
- The device for performing the test (each packaged separately with a dehydrating tablet)
- A tube for the extraction pad
- A mouthpiece cap
- A sterile cotton swab
- A film (which can be applied to the device when the test is performed outdoors)
- Instructions
- quick guide