Page 8 - HSP-Assure Test Booklet FDA Auth Booklet - FINAL 7_2020RV2

in the specimen. Therefore, any shade of color in the test region should be considered positive. 3. Authorized laboratories that receive your product will notify the relevant public health authorities of Combined Sites (Serum +
Note that this is a qualitative test only, and cannot determine the concentration of analytes in the their intent to run your product prior to initiating testing. 105 105 100% 96.5%-100%
specimen. 4. Authorized laboratories using your product will have a process in place for reporting test results to Blood)
2. Insufficient specimen volume, incorrect operating procedure or expired tests are the most likely healthcare providers and relevant public health authorities, as appropriate.
reasons for control band failure. 5. Authorized laboratories will collect information on the performance of your product and report to
DMD/OHT7-OIR/OPEQ/CDRH（via email: CDRH-EUA-Reporting@fda.hhs.gov）and Assure Tech
QUALITY CONTROL (Hangzhou Co., Ltd). (via email: contact@direagent.com) any suspected occurrence of false reactive or Table 3. IgM PPA for the Assure COVID-19 IgG/IgM Rapid Test Device
false non-reactive results and significant deviations from the established performance characteristics of
Internal Procedural Controls your product of which they become aware. # PCR Assure COVID-19 IgG/IgM Rapid Test
The Assure COVID-19 IgG/IgM Rapid Test Device has built-in (procedural) controls. Each test device 6. All laboratory personnel using your product must be appropriately trained in immunoassay techniques Days post
has an internal standard zone to ensure proper sample flow. The user should confirm that the blue band and use appropriate laboratory and personal protective equipment when handling this kit and use your Site symptom Positive Device
should be always located at the “C” region before testing, and the red band should be always present product in accordance with the authorized labeling. All laboratory personnel using the assay must also be at any
before result interpretation. trained in and be familiar with the interpretation of results of the product. onset #Positive PPA 95%CI
External Positive and Negative Controls 7. Assure Tech. (Hangzhou Co., Ltd), authorized distributors, and authorized laboratories using your time Results
Good laboratory practice suggests testing positive and negative external controls to ensure that the test product will ensure that any records associated with this EUA are maintained until otherwise notified by
reagents are working and that the test is correctly performed. FDA. Such records will be made available to FDA for inspection upon request. ≤7 8 8 100% 67.6%-100%
*The Letter of Authorization refers to, “Laboratories certified under the Clinical Laboratory Improvement
LIMITATIONS OF THE TEST Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform moderate or high 62.1%-
For use under an Emergency Use Authorization Only complexity tests” as “authorized laboratories”. (Site 1+3+4) 8-14 15 13 86.7% 96.3%
1. Use of the Assure COVID-19 IgG/IgM Rapid Test Device is limited to laboratory personnel who PERFORMANCE CHARACTERISTICS Serum
have been trained. Not for home use. 65.3%-
2. The Assure COVID-19 IgG/IgM Rapid Test Device is for in vitro diagnostic use only. The test Clinical Evaluation ≥15 25 21 84%
should be used for the detection of SARS-CoV-2 antibodies in whole blood, serum or plasma 93.6%
specimens only. Neither quantitative value nor the rate of increase in SARS-CoV-2 antibody ≤7 1 1 100% 20.7%-100%
concentration can be determined by this qualitative test. Study I (Site 2)
3. The Assure COVID-19 IgG/IgM Rapid Test Device is not validated for finger stick blood. Total of 61 positive and 105 negative serum or venous whole blood samples were collected at 4 different Venous Whole 8-14 3 3 100% 43.9%-100%
4. The Assay Procedure and the Interpretation of Assay Result must be followed closely when testing study sites. These samples were tested with both RT-PCR method for SARS-CoV-2 infection and Assure
for the presence of SARS-CoV-2 virus specific antibodies in the serum, plasma or whole blood COVID-19 IgG/IgM Rapid Test device for antibodies. The obtained sensitivity and specificity results are Blood ≥15 9 9 100% 70.1%-100%
specimen from individual subjects. For optimal test performance, proper sample collection is summarized in following tables.
critical. Failure to follow the procedure may give inaccurate results. Table 1. IgG PPA for the Assure COVID-19 IgG/IgM Rapid Test Device Combined Sites
5. Reading test results earlier than 10 minutes after the addition of Buffer may yield erroneous results. 80.2%-
Do not interpret the results after 20 minutes. # PCR Assure COVID-19 IgG/IgM Rapid Test (Serum + - 61 55 90.2%
6. The Assure COVID-19 IgG/IgM Rapid Test Device will only indicate the presence of SARS-CoV- Days post Blood) 95.4%
2 antibodies in the specimen and should not be used for the diagnosis of SARS-CoV-2. Positive Device
7. In the early onset of symptom, anti-SARS-Cov-2 IgM and IgG antibody concentrations may be Site symptom at any
below detectable levels. onset #Positive
8. A high dose “hook effect” may occur where the color intensity of test band decreases as the time PPA 95%CI Table 4. IgM NPA for the Assure COVID-19 IgG/IgM Rapid Test Device
concentration of anti-SARS-CoV-2 IgG/IgM increases. If a “hook effect” is suspected, dilution of Results
specimens may increase color intensity of the test band. 52.9%- Assure COVID-19 IgG/IgM Rapid Test
9. Results from immunosuppressed patients should be interpreted with caution. ≤7 8 7 87.5%
10. As with all diagnostic tests, all results must be interpreted together with other clinical information 97.8% # PCR Device
available to the physician. (Site 1+3+4) Site
11. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis 62.1%- Negative #Negative
for patient management decisions, IgM antibodies may not be detected in the first few days of Serum 8-14 15 13 86.7% Results NPA 95%CI
infection; the sensitivity of the Assure COVID-19 IgG/IgM Rapid Test Device early after infection 96.3%
is unknown. False positive results for IgM and IgG antibodies may occur due to cross-reactivity ≥15 25 25 100% 86.7%-100% (Site 1+3+4) 92.7%-
from pre-existing antibodies or other possible causes. Samples with positive results should be 96 94 97.9%
confirmed with alternative testing method(s) and clinical findings. (Site 2) ≤7 1 1 100% 20.7%-100% Serum 99.4%
12. A negative result can occur if the quantity of the anti-SARS-CoV-2 antibodies present in the
specimen is below the detection limits of the assay, or the antibodies that are detected are not Venous Whole 8-14 3 3 100% 43.9%-100% (Site 2)
present during the stage of disease in which a sample is collected. 9 9 100% 70.1%-100%
13. Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, Blood ≥15 9 9 100% 70.1%-100% Venous Whole Blood
such as coronavirus HKU1, NL63, OC43, or 229E.
14. Results from antibody testing should not be used to diagnose or exclude SARS-CoV-2 infection Combined Sites Combined Sites (Serum + 105 103 98.1% 93.3%-
or to inform infection status. 86.5%- Blood) 99.5%
15. Not for the screening of donated blood. (Serum + - 61 58 95.1% 98.3%
Blood)
The sensitivity of the test is impacted after being open for one hour-the intensity of the T line becomes Study II: Independent Clinical Agreement Validation
weak. Testing must be performed within one hour after opening the pouch. The COVID-19 IgG/IgM Rapid Test Device from Assure Tech. (Hangzhou) Co., Ltd. was tested on 2020-
Table 2. IgG NPA for the Assure COVID-19 IgG/IgM Rapid Test Device 06-15 at the Frederick National Laboratory for Cancer Research (FNLCR) sponsored by the National
Conditions of Authorization for the Laboratory Cancer Institute (NCI). The test was validated against a panel of previously frozen samples consisting of
Assure COVID-19 IgG/IgM Rapid Test
The Assure COVID-19 IgG/IgM Rapid Test Device Letter of Authorization, along with the authorized 30 SARS-CoV-2 antibody-positive serum samples and 80 antibody-negative serum and plasma samples.
Each of the 30 antibody-positive samples was confirmed with a nucleic acid amplification test (NAAT)
Fact Sheet for Healthcare Providers, the authorized Fact Sheet for Recipients, and other authorized # PCR Device and both IgM and IgG antibodies were confirmed to be present in all 30 samples. The presence of
labeling are available on the FDA website: https://www.fda.gov/medical-devices/coronavirus-disease- Site antibodies in the samples was confirmed by several orthogonal methods prior to testing with the Assure
2019-covid-19-emergency-use-authorizations-medical-devices/vitro-diagnostics-euas. Negative #Negative COVID-19 IgG/IgM Rapid Test Device. The presence of IgM and IgG antibodies specifically was
Authorized laboratories using the Assure COVID-19 IgG/IgM Rapid Test Device (“your product” in the NPA 95%CI confirmed by one or more comparator methods. Antibody-positive samples were selected at different
conditions below), must adhere to the Conditions of Authorization indicated in the Letter of Authorization Results antibody titers.
as listed below:
1. Authorized laboratories* using your product will include the test result reports, all authorized Fact (Site 1+3+4) 96 96 100% 96.2%-100% All antibody-negative samples were collected prior to 2020 and include: i) Seventy (70) samples selected
without regard to clinical status, “Negatives” and ii) Ten (10) samples selected from banked serum from
Sheets. Under exigent circumstances, other appropriate methods for disseminating these Fact Sheets may Serum HIV+ patients, “HIV+”. Testing was performed by one operator using one lot of the Assure COVID-19
be used, which may include mass media.
2. Authorized laboratories using your product will use your product as outlined in the Instructions for Use. (Site 2) IgG/IgM Rapid Test Device. Confidence intervals for sensitivity and specificity were calculated per a
score method described in CLSI EP12-A2 (2008).
Deviations from the authorized procedures, including the authorized clinical specimen types, authorized 9 9 100% 70.1%-100% For evaluation of cross-reactivity with HIV+, it was evaluated whether an increased false positive rate
control materials, authorized other ancillary reagents and authorized materials required to use your product Venous Whole Blood
are not permitted. among antibody-negative samples with HIV was statistically higher than the false positive rate among
Revision 1.2 Effective date: 2020-07-06 Page 2/3