Page 8 - HSP-Assure Test Info Booklet Direct Final 12_2020

reinfection.

Negative: The colored line in the control region (C) changes from blue 15. A negative result can occur if the quantity of the anti-SARS-CoV-2 antibodies present in the Table 2. IgG/IgM NPA for the Assure COVID-19 IgG/IgM Rapid Test Device

to red. No line appears n IgM or IgG test regions. specimen is below the detection limits of the assay, or the antibodies that are detected are not # PCR IgG (Assure Device) IgM (Assure Device)
i

present during the stage of disease in which a sample is collected. Site Negative Antibody NPA 95%CI Antibody NPA 95%CI

16. Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus Negative Negative
strains, such as coronavirus HKU1, NL63, OC43, or 229E. (Site 1+3+4) 96 96 100% 96.2%-100% 94 97.9% 92.7%-99.4%

17. Results from antibody testing should not be used to diagnose or exclude SARS-CoV-2 infection Serum
or to inform infection status. (Site 2)

18. Not for the screening of donated blood. Venous Whole Blood 9 9 100% 70.1%-100% 9 100% 70.1%-100%

Invalid: Control line (C) is still completely or partially blue, and fails to Combined Sites (Serum

completely change from blue to red. Insufficient buffer volume or The sensitivity of the test is impacted after being open for one hour-the intensity of the T line becomes + Blood) 105 105 100% 96.5%-100% 103 98.1% 93.3%-99.5%

incorrect procedural techniques are the most likely reasons for control weak. Testing must be performed within one hour after opening the pouch.

line failure. Review the procedure and repeat the procedure with a new
test device. If the problem persists, discontinue using the test kit Conditions of Authorization for the Laboratory The NPA/specificity of the Assure COVID-19 IgG/IgM Rapid Test Device for IgG/IgM is 99.04%.

immediately and contact your local distributor.
The Assure COVID-19 IgG/IgM Rapid Test Device Letter of Authorization, along with the authorized Study II: Independent Clinical Agreement Validation

Fact Sheet for Healthcare Providers, the authorized Fact Sheet for Recipients, and other authorized The COVID-19 IgG/IgM Rapid Test Device from Assure Tech. (Hangzhou) Co., Ltd. was tested on

labeling are available on the FDA website: 2020-06-15 at the Frederick National Laboratory for Cancer Research (FNLCR) sponsored by the

https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations National Cancer Institute (NCI). The test was validated against a panel of previously frozen samples
NOTE: -medical-devices/vitro-diagnostics-euas. consisting of 30 SARS-CoV-2 antibody-positive serum samples and 80 antibody-negative serum and

1. The color intensity in the test region may vary depending on the concentration of analytes Authorized laboratories using the Assure COVID-19 IgG/IgM Rapid Test Device (“your product” in the plasma samples. Each of the 30 antibody-positive samples was confirmed with a nucleic acid

present in the specimen. Therefore, any shade of color in the test region should be considered conditions below), must adhere to the Conditions of Authorization indicated in the Letter of amplification test (NAAT) and both IgM and IgG antibodies were confirmed to be present in all 30

positive. Note that this is a qualitative test only, and cannot determine the concentration of Authorization as listed below: samples. The presence of antibodies in the samples was confirmed by several orthogonal methods prior

analytes in the specimen. 1. Authorized laboratories* using your product will include the test result reports, all authorized Fact to testing with the Assure COVID-19 IgG/IgM Rapid Test Device. The presence of IgM and IgG

2. Insufficient specimen volume, incorrect operating procedure or expired tests are the most likely Sheets. Under exigent circumstances, other appropriate methods for disseminating these Fact Sheets antibodies specifically was confirmed by one or more comparator methods. Antibody-positive samples

reasons for control band failure. may be used, which may include mass media. were selected at different antibody titers.

2. Authorized laboratories using your product will use your product as outlined in the Instructions for All antibody-negative samples were collected prior to 2020 and include: i) Seventy (70) samples

QUALITY CONTROL Use. Deviations from the authorized procedures, including theauthorized clinical specimen types, selected without regard to clinical status, “Negatives” and ii) Ten (10) samples selected from banked

authorized control materials, authorized other ancillary reagents and authorized materialsrequired to use serum from HIV+ patients, “HIV+”. Testing was performed by one operator using one lot of the Assure

Internal Procedural Controls your product are not permitted. COVID-19 IgG/IgM Rapid Test Device. Confidence intervals for sensitivity and specificity were

CLSI EP12-A2 (2008).

The Assure COVID-19 IgG/IgM Rapid Test Device has built-in (procedural) controls.Each test device 3. Authorized laboratories that receive your product will notify the relevant public health authorities of calculated per a score method described in

has an internal standard zone to ensure proper sample flow. The user should confirm that the blue band their intent to run your product prior to initiating testing. For evaluation of cross-reactivity with HIV+, it was evaluated whether an increased false positive rate

should be always located at the “C” region before testing, and the red band should be always present 4. Authorized laboratories using your product will have a process in place for reporting test results to among antibody-negative samples with HIV was statistically higher than the false positive rate among

before result interpretation. healthcare providers and relevant public health authorities, as appropriate. antibody-negative samples without HIV (for this, a confidence interval for the difference in false

External Positive and Negative Controls 5. Authorized laboratories will collect information on the performance of your product and report to positive rates was calculated per a score method described by Altman). The results and data analysis are

and 4 below.

Good laboratory practice suggests testing positive and negative external controls to ensure that the test DMD/OHT7-OIR/OPEQ/CDRH（ via email: CDRH-EUA-Reporting@fda.hhs.gov） and Assure Tech shown in the Tables 3
reagents are working and that the test is correctly performed. (Hangzhou Co., Ltd). (via email: contact@direagent.com) any suspected occurrence of false reactive or

false non-reactive results and significant deviations from the established performance characteristics of Table 3. Summary Results
LIMITATIONS OF THE TEST your product of which they become aware. Assure COVID-19 Comparator Method

For use under an Emergency Use Authorization Only 6. All laboratory personnel using your product must be appropriately trained in immunoassay techniques IgG/IgM Rapid Test Positive Negative Negative, Total

1. Use of the Assure COVID-19 IgG/IgM Rapid Test Device is limited to laboratory personnel who and use appropriate laboratory and personal protective equipment when handling this kit and use your Positive Device (IgM/IgG) + (IgM/IgG) - HIV+ 27

product in accordance with

the
authorized labeling. All laboratory personnel using the assay must also
0
IgM+/IgG+
0

27
have been trained. Not for home use. be trained in and be familiar with the interpretation of results of the product.

2. The Assure COVID-19 IgG/IgM Rapid Test Device is 7. Assure Tech. (Hangzhou Co., Ltd), authorized distributors, and authorized laboratories using your IgM+, IgG- 3 1 0 4
for in vitro diagnostic use only. The test

should be used for the detection of SARS-CoV-2 antibodies in venous whole blood, fingerstick product will ensure that any records associated with this EUA are maintained until otherwise notified by IgM-, IgG+ 0 0 0 0

whole blood, serum or plasma specimens only. Neither quantitative value nor the rate of increase FDA. Such records will be made available to FDA for inspection upon request. Negative IgM-/IgG- 0 69 10 79

in SARS-CoV-2 antibody concentration can be determined by this qualitative test. *Use of this test with all authorized specimen types is limited to laboratories certified under the Clinical Total (n=110) 30 70 10 110

3. The Assay Procedure and the Interpretation of Assay Result must be followed closely when Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, that meet requirements to

testing for the presence of SARS-CoV-2 virus specific antibodies in the serum, plasma or whole perform moderate or high complexity tests.

blood specimen from individual subjects. For optimal test performance, proper sample collection Table 4. Summary Statistics
is critical. Failure to follow the procedure may give inaccurate results. This test is also authorized for use with fingerstick whole blood specimens only at the Point of Care Measure Estimate Confidence Interval

4. Reading test results earlier than 15 minutes after the addition of Buffer may yield erroneous (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of

results. Do not interpret the results after 30 minutes. Compliance, or Certificate of Accreditation. IgM+ Sensitivity (PPA) (30/30) 100% (88.7%; 100%)

5. Adding more or less than 1 drop of specimen may lead to erroneous results. IgM- Specificity (NPA) (79/80) 98.8% (93.3%; 98.8%)

6. Adding 1 drop of buffer or more than 4 drops of buffer may lead to erroneous results. PERFORMANCE CHARACTERISTICS IgG+ Sensitivity (PPA) (27/30) 90.0% (74.4%; 96.5%)

7. The Assure COVID-19 IgG/IgM Rapid Test Device will only indicate the presence of IgG- Specificity (NPA) (80/80)100% (95.4%; 100%)

SARS-CoV-2 antibodies in the specimen and should not be used for the diagnosis of acute Clinical Evaluation Combined Sensitivity (30/30) 100% (88.7%; 100%)
SARS-CoV-2. A molecular assay should be used to evaluate symptomatic patients for acute Combined Specificity (79/80) 98.8% (93.3%; 98.8%)

COVID-19. Combined PPV for prevalence = 5% 80.8% (40.9%; 96%)
8. In the early onset of symptom, anti-SARS-Cov-2 IgM and IgG antibody concentrations may be Study I Combined NPV for prevalence =

below detectable levels. Total of 61 positive and 105 negative serum or venous whole blood samples were collected at 4 different 5% 100% (99.4%; 100%)

9. SARS-CoV-2 IgG antibodies may be below detectable levels in patients who have been exhibiting study sites. These samples were tested with both RT-PCR method for SARS-CoV-2 infection and
symptoms for less than 15 days. Assure COVID-19 IgG/IgM Rapid Test device for antibodies. The obtained PPA/sensitivity and Cross-reactivity with HIV+ (0/10) 0% -----------------
following tables.

10. A high dose “hook effect” may occur where the color intensity of test band decreases as the NPA/specificity results are summarized in not detected
concentration of anti-SARS-CoV-2 IgG/IgM increases. If a “hook effect” is suspected, dilution Table 1. IgG/IgM PPAfor the Assure COVID-19 IgG/IgM Rapid Test Device

of specimens may increase color intensity of the test band. IgG (Assure Device) IgM (Assure Device) Study III

11. Results from immunosuppressed patients should be interpreted with caution. Site Days from # PCR Antibody Antibody Total of 42 positive and 113 negative fingerstick whole blood samples were collected and tested at 3

12. As with all diagnostic tests, all results must be interpreted together with other clinical symptom Positive Positive PPA 95%CI Positive PPA 95%CI different POC sites. These samples were tested with both RT-PCR method for SARS-CoV-2 infection

information available to the physician. and Assure COVID-19 IgG/IgM Rapid Test device for antibodies. The PPA/sensitivity and

13. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis (Site 1+3+4) 0-7 days 8 7 87.5% 52.9%-97.8% 8 100% 67.6%-100% NPA/specificity results are summarized in following tables.

for patient management decisions. Antibodies may not be detected in the first few days of Serum 8-14 days 15 13 86.7% 62.1%-96.3% 13 86.7% 62.1%-96.3%
infection; the sensitivity of the Assure COVID-19 IgG/IgM Rapid Test Device early after ≥15 days 25 25 100% 86.7%-100% 21 84% 65.3%-93.6%
infection is unknown. False positive results for IgM and IgG antibodies may occur due to (Site 2) 0-7 days 1 1 100% 20.7%-100% 1 100% 20.7%-100% Table 5. IgG/IgM PPA for the Assure COVID-19 IgG/IgM Rapid Test Device

cross-reactivity from pre-existing antibodies or other possible causes. Consider other information Venous 8-14 days 3 3 100% 43.9%-100% 3 100% 43.9%-100%

including clinical history and local disease prevalence, in assessing the need for a second but Whole Blood ≥15 days 9 9 100% 70.1%-100% 9 100% 70.1%-100% Days from # PCR IgG (Assure Device) IgM (Assure Device)

different serology test to confirm an immune response. Site symptom Positive Antibody PPA 95%CI Antibody PPA 95%CI

14. It is unknown at this time if the presence of antibodies to SARS-CoV-2 confers immunity to Positive Positive

Number:1110032033 REV1.4 Effective date: 2020-09-22 Page 2/3