LG Chem AdvanSure SARS-CoV-2 IgG(S1) ELISA Human Serum and Plasma Antibodies Instruction Manual

AdvanSure™ SARS-CoV-2
IgG(S1) ELISA
Instruction for Use
May. 2022 (REV07)

For In Vitro Diagnostic Use
SCE0001K00
LG CHEM Ltd.

Diagnostic-dong, LG Chem song plant, 151 Osongsaengmyeong 1-ro, Osong-up, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do, Republic of Korea Medical Technology Promedt Consulting GmbH Altenhofstrasse 80 66386 St. Ingbert Germany
For in vitro diagnostic use only.
For prescription use only.
For use under emergency use authorization only.

INTENDED USE

The adventure TM SARS-CoV-2 IgG(S1) ELISA is an Enzyme-Linked Immunosorbent Assay (ELISA) intended for the qualitative detection of IgG antibodies to SARS-CoV-2 in human serum and plasma (dipotassium EDTA, sodium heparin, or sodium citrate). The adventure TM SARS-CoV-2 IgG(S1) ELISA is intended for use as an aid in identifying individuals with an adaptive immune response to SARS- CoV-2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. The adventure SARS-CoV-2 IgG(S1) ELISA should not be used to diagnose or exclude acute SARS-CoV2 infection. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C 263a, that meet requirements to perform high complexity tests.

Results are for the detection of SARS CoV-2 IgG antibodies. IgG antibodies to SARS-CoV-2 are generally detectable in the blood several days after initial infection, although the duration of time antibodies is present post-infection is not well characterized. Individuals may have detectable viruses present for several weeks following seroconversion. Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities. Negative results do not preclude acute SARS-CoV-2 infection. If the acute infection is suspected, direct testing for SARS-CoV-2 is necessary. False-positive results for AdvanSure TM SARS-CoV-2 IgG(S1) ELISA may occur due to cross-reactivity from pre-existing antibodies or other possible causes. Samples should only be tested from individuals who are 15 days or more post symptom onset. The adventure TM SARS-CoV-2 IgG(S1) ELISA is only for use under the Food and Drug Administration’s Emergency Use Authorization.

PRINCIPLE

adventure TM SARS-CoV-2 IgG(S1) ELISA is a one-step antigen capture format ELISA for the qualitative detection of anti-SARS-CoV-2 IgG(S1) antibodies in human serum and plasma. First reaction: SARS-CoV-2 IgG(S1) antibodies in test sample are incubated with sample dilution buffer and recombinant SARS-CoV-2 S1 domain bound on microwell. Second reaction: After washing, SARS-CoV-2 IgG(S1) antibodies from the sample bound to the antigen on microwell are detected by a secondary antibody conjugated to HRP (anti-human IgG conjugated with peroxidase). Substrate color development reaction: Tetramethylbenzidine (TMB) solution containing hydrogen peroxide is added to the well. If the detection antibody is present, the TMB will oxidize resulting in light blue color development dependent upon the amount of bound detection antibody. The substrate reaction is stopped by adding 1N sulfuric acid. The intensity of the color is measured with an ELISA reader (spectrophotometer) at 450nm.

COMPOSITION

bottle
| Stop|    SOLN
---|---
Stop Solution, ready for use| 1N Sulfuric acid| 75ml, 1 bottle
| Wash| SOLN
---|---
Washing Solution (20X)| PBS buffer (20X)| 110 ml 1 bottle
| Control| +
---|---
Positive Control| Human Serum or plasma (< 50%), PBS buffer| 0.8 ml
| Control| –
---|---
Negative Control| Human Serum or plasma (< 50%), PBS buffer| 1.3 ml
Calibrator| Calibrator| Human Serum or plasma (< 50%), PBS buffer| 1.3 ml
| Plate sealing film| –| 10 each
| Protective foil pouch| –| 1 each

MATERIALS AND EQUIPMENT REQUIRED BUT NOT PROVIDED

1. Adjustable micropipettes and filtered tips
   i. 1~10µl
   ii. 20~200µl
   iii. 200~1000µl

2. ELISA washer
   i. Recommended. Washing of the microwell plates can also be carried out manually

3. ELISA Reader
   i. The wavelength of 450nm
   ii. Reference wavelength of 650nm

4. Vortex mixer

5. Tabletop centrifuge

6. Incubator (37°C)

7. Distilled water

8. Corning tube (15ml, 50ml)

9. Microtube (1.5ml)

10. Digital timer

11. Lab wipes

12. Disposable gloves

TEST PROCESS

1. SPECIMEN PREPARATION
   • Procure the appropriate sample type
   a. 10µl of either serum or plasma (EDTA, Heparin, Citrate) samples can be used in the assay.
   i. If samples are frozen, they must be completely thawed at room temperature prior to testing.
   ii. Solid materials, such as blood corpuscles or blood coagulation components, should be removed by centrifugation prior to use.
   • Sample should be properly mixed for 5 to 10 seconds using a vortex mixer before centrifugation.
   Important:
   • Avoid using samples containing inhibitors of horseradish peroxidase (HRP) (e.g. sodium azide), which may result in false-negative results.
   • Pay close attention to sample quality as hemolysis may lead to inaccurate results.

2. TEST PREPARATION
   Preparation of washing solution
   ① Before beginning analysis, prepare the necessary amount of washing solution with 20X washing concentrate and dilute it to 20-fold with distilled or deionized water at room temperature.
   ② For each well, approximately 3mL of washing solution is used but additional volume may be needed depending on the washing method or instruments used. 1X Washing solution volume = 3 ml x (sample number + 6)

Caution

• Use distilled or deionized water only, with the exception to any deionized water prepared by polystyrene ion-exchange resin because such preparation may result in the inactivation of HRP.
• Avoid using metal containers for storage.

Preparation of substrate solution (TMB)
① Dilute the proper amount of Tetramethylbenzidine (TMB) concentrate with substrate dilution buffer in accordance with the number of wells that will be used before using substrate solution.
② For each well, 100µl of substrate solution is used but additional volume may be needed for the solution loss by repeated pipetting.
1X Substrate solution volume = 100µl x (Sample number + 6)

Caution

• Avoid using metal-containing containers or pipettes which may result in color development of prepared substrate solution.
• Use distilled water only in order to avoid contamination with metal ions often found in tap water.
• Avoid any body contact with TMB concentrate which contains DMSO and mix well before dilution with buffer solution.
• Take care not to contaminate substrate solution with sodium azide, a commonly used preservative, which is also an inhibitor of HRP.
• TMB concentrate may occasionally freeze during storage in the refrigerator, but it can still be used after complete dissolution.
• Diluted TMB solution should be prepared again if the color of the solution is not colorless anymore (e.g. turns from colorless to blue).

3. ASSAY PROCESS
①Bring the microwell plate to room temperature about 30 minutes prior to use and mix well.
②Determine the number of wells needed for the test as below.
One (1) well is used to test one (1) sample.
For each test, 6 additional wells (2 negative controls, 2 positive controls, and 2 calibrators) are needed apart from the number of test samples.
A number of wells = Sample number + 6
③After recording the position of the wells for control reagents and test samples, dispense 100µl of sample diluent into each well except for the substrate blank.
④Dispense 10µl of negative, positive control, calibrator, and test samples into each well, gently shake for about 5 ~ 10 seconds making certain of no spillage. If necessary, cover the plate with a sealer.
⑤Incubate the sealed plate at 37±1°C for 60±5 minutes.
⑥After reaction, remove the plate sealer and wash 5 times as follows. First, remove any remaining contents of the wells with an aspirator then fill completely with the washing solution and leave the plate for 5 ∼15 seconds. Repeat the process of aspiration 5 times and invert the plate and tap on absorbent tissue to remove excess washing solution. ⑦Except for substrate blank, dispense 100µl of conjugate solution into all wells and seal with plate sealer.
⑧Incubate the sealed plate at 37±1°C for 30±1 minutes. After the reaction, take off the plate sealer, remove any remaining contents of the wells with an aspirator and wash 5 times with a washing solution. Invert the plate and tap on absorbent tissue to remove excess washing solution.
⑨Dispense 100µl of substrate solution into all wells including the substrate blank.
⑩Incubate at 18 ~ 30°C in a dark place, for 30±1 minutes.
⑪Dispense 100µl of stop solution into all wells including substrate blank.
⑫If there is moisture under the plate wipe the bottom of the plate with a lab wipe since moisture can interfere with measurement results. Read the microwell plate at a wavelength of 450nm. For dual-wavelength readers, set the reference wavelength of 650nm.

Caution

• DO NOT open the microwell plate until it has come to room temperature for 30 minutes. The coated antigen is sensitive to moisture.
• Any unused wells should be stored at 2 ~ 8°C in the supplied foil zipper bag with desiccant
• DO NOT touch the bottom of any unused wells

QUALITY CONTROL

Positive and negative controls are provided with the kit. These controls are required as internal controls in order to identify reagent failure. Two (2) replicates of the positive control and two (2) replicates of the negative control must be used with each test. The negative control is produced by pooling several previously-confirmed negative sera or plasma samples. The positive control is produced by pooling several previously-confirmed positive serum or plasma samples and diluted with the pooled negative specimens. The optical density (OD) value for each negative control must be greater than or equal to -0.005 and less than or equal to 0.2. If one of two values is outside this range, the test must be repeated once. The mean OD of positive control is calculated by averaging the two OD values obtained for positive control. The OD value for positive control must be greater than or equal to 0.800 and the difference between two values must be less than or equal to 0.650. If any of the two values is (are) outside the criteria, the test must be repeated once.

INTERPRETATION OF THE RESULT

The mean optical density of the calibrator is calculated by averaging the two OD values obtained for the calibrator. The OD value for each calibrator must be greater than or equal to -0.005 and less than or equal to 0.2. If the OD value is measured between -0.005 to 0.000, it should be rounded up to 0.000 for the calculation of the mean OD. If one of two values is outside this range, the test must be repeated. The mean optical density of positive control is calculated by averaging the two OD values obtained for positive control. The OD value for positive control must be greater than or equal to 0.800 and the difference between two values must be less than or equal to 0.650. If any of the conditions are outside the criteria, the test must be repeated. Calculate the cut-off value according to the following formula: Cut-off = Mean OD of calibrator + 0.260 Calculate the S/Co (Signal to cutoff ratio) according to the following formula S/Co = Sample OD /Cut-off

than or equal to -0.005 and less than or equal to 0.2. (-0.005 ≤ NC < 0.2)
Positive Control (PC)| Valid| The OD value for positive control must be greater than or equal to 0.800 and the difference between two values must be less than or equal to 0.650. (PC ≥ 0.8 and│PC1 – PC2│< 0.65)
S/Co Value| Interpretation| Remark
---|---|---
S/Co < 1.0| Negative| Samples with S/Co less than 1.0 are considered nonreactive and no further testing is required. IgG antibodies for SARS-Cov-2 are not detected.
S/Co ≥ 1.0| Positive| Samples with S/Co greater than or equal to 1.0 are considered as reactive. IgG antibodies for SARS-CoV-2 are detected.

STORAGE CONDITION

This kit should be stored at 2 ~ 8 °C. Please refer to the printed expired date on the product package. The reagents are stable for 10 days from the opening date when stored at 2 ~ 8 °C.

ANALYTICAL PERFORMANCE

1. Analytical Specificity
Cross-reactivity
The cross-reactivity of the AdvanSure TM SARS-CoV-2 IgG(S1) ELISA was evaluated by testing SARS-CoV-2 seronegative specimens from patients with antibodies to other coronaviruses or medical conditions. A total of 76 specimens from 10 different categories were tested. There was no cross- reaction (false-positive results) observed with the AdvanSure TM SARS-CoV-2 IgG(S1) ELISA in any of the specimens that were tested. The results are summarized in the table below.

Class Specificity
adventure TM SARS-CoV-2 IgG(S1) ELISA assay demonstrates class-specific reactivity only to human IgG isotypes. No binding interactions were observed with anti-SARS-CoV-2 IgM antibodies.

Interference
Potential interfering substances, IgA, IgM, and IgE were tested in human serum to determine if they were above physiologically relevant levels, and whether they could cause false positives or false negatives on AdvanSure TM SARS-CoV-2 IgG(S1) ELISA. Two (2) positive specimens and one (1) negative specimen were spiked with potential interfering substances and elevated IgA, IgM, IgE. The samples were subsequently tested in duplicates and interference was observed with hemoglobin, total protein, bilirubin, and IgM. The used substances are summarized in the table below.

Interfering substance| Test Concentration| Interfering substance| Test Concentration
---|---|---|---
Cholesterol| 250 (mg/dL)| IgA| 350 (mg/dL)
Hemoglobin| 500 (mg/dL)| IgM| 250 (mg/dL)
Bilirubin| 20 (mg/dL)| IgE| 43000 (ug/dL)
Protein (Albumin)| 12 g/dL| IgD| 3 (mg/dL)

2. Matrix Equivalency
To investigate the utility of plasma samples, five (5) negative matrix sets of serum and corresponding plasma (K2 E DTA, Sodium Heparin, and Sodium Citrate plasma from the same donors) were evaluated at four (4) different concentrations (negative, high negative, low positive, high positive). The results are summarized in the table below.

Passing Bablok Regression Equation (S/Co)
Y =Plasma, X=Serum| 0.9338x+0.0000| 0.9197x+0.0049| 1.0579x-0.0015
Slope (95% C.I)| 0.8905 – 0.99865| 0.8755 – 0.9849| 0.9864 – 1.692
R2| 0.9839| 0.9798| 0.9767

CLINICAL PERFORMANCE

1. Positive Percent Agreement Studies
Two Positive Percent Agreement (PPA) studies were conducted with retrospective serum specimens from subjects where SARS-CoV-2 infection status was confirmed with an FDA emergency use authorized RT-PCR test. For PPA study #1, the adventure TM SARS-CoV-2 IgG(S1) ELISA displayed a 16.7% PPA in study subjects confirmed positive for infection status by RT-PCR within 0 to 7 days. From 8 to 14 days post-RT-PCR confirmation, the PPA was 100%, and for ≥15 days post- RT-P CR confirmation the PPA was 100%. The following table provides PPA by the time of sampling from RT-PCR confirmation:

| AdvanSure TM SARS-CoV-2 IgG(S1) ELISA
---|---
Days from PCR confirmed| Number of Subjects Tested| IgG Positive results| IgG PPA| 95% CI
0-7 days| 12| 2| 16.7%| 4.7-44.8%
8-14 days| 12| 12| 100%| 75.8-100%
≥15 days| 41| 41| 100%| 91.4-100%

For PPA study #2, the adventure TM SARS-CoV-2 IgG(S1) ELISA displayed a 41.2% P PA for ≤ 7 days from symptom onset. From 8 to 14 days from symptom onset, the P PA was 87%, and for ≥15 days post-symptom onset the PPA was 98.9%. The following table provides PPA by time post-symptom onset:

| AdvanSure TM SARS-CoV-2 IgG(S1) ELISA
---|---
Days from Symptom Onset| Number of Subjects Tested| IgG Positive results| IgG PPA| 95% CI
0-7 days| 17| 7| 41.2%| 21.6-64.0%
8-14 days| 46| 40| 87.0%| 74.3-93.9%
≥15 days| 87| 86| 98.9%| 93.8-99.8%

2. Negative Percent Agreement
Two Negative Percent Agreement (NPA) studies were conducted with serum specimens from 400 study subjects: 200 serum samples collected before the COVID-19 pandemic started and were presumed negative for the purposes of the study and 200 serum samples confirmed negative for SARS-CoV-2 infection status by an FDA emergency use authorized RT-PCR test. The following tables provide NPA results with samples collected before and after the start of the COVID-19 pandemic:

| Pre-Pandemic Specimens AdvanSure TM SARS-CoV-2 IgG(S1) ELISA
---|---
Number of Subjects Tested| IgM Negative Results| IgG NPA (95% CI)
200| 199| 99.5% (CI: 97.2-99.9%)
| Confirmed Negative Specimens AdvanSure TM SARS-CoV-2 IgG(S1) ELISA
---|---
Number of Subjects Tested| IgM Negative Results| IgG NPA (95% CI)
200| 198| 99.0% (CI: 96.4-99.7%)

INDEPENDENT CLINICAL AGREEMENT VALIDATION STUDY

adventure TM SARS-CoV-2 IgG(S1) ELISA was tested on April 01. 2022 at the Frederick National Laboratory for Cancer Research (FNLCR), a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI). The test was validated against a panel of previously frozen samples consisting of 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) and both IgM and IgG antibodies were confirmed to be present in all 30 samples. The presence of antibodies in the samples was confirmed by several orthogonal methods prior to testing with the COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma). The presence of IgM and IgG antibodies specifically was confirmed by one or more comparator methods. All antibody-positive samples were selected at different antibody titers. 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 HIV+ patients, “HIV+”. For evaluation of cross-reactivity with HIV+, it was evaluated whether an increased false-positive rate among antibody-negative samples with HIV was statistically higher than the false positive rate among antibody-negative samples without HIV (for this, a confidence interval for the difference in false-positive rates was calculated per a score method described by Altman). The results and data analysis are shown in the tables below.

Summary Results

AdvanSure TM SARS-CoV-2 IgG(S1) ELISA| Comparator Method| Total
---|---|---
Antibody Positive| Antibody Negative
Negative| HIV+
IgG +| 30| 1| 0| 31
IgG –| 0| 69| 10| 79
Total| 30| 70| 10| 110

Summary Statistics

Limitation of this study

• Samples were not randomly selected, and sensitivity and specificity estimates may not be indicative of the real-world performance of the device.
• These results are based on serum and plasma samples only and may not be indicative of performance with other sample types, such as whole blood, including finger stick blood.
• The number of samples in the panel is a minimally viable sample size that still provides reasonable estimates and confidence intervals for test performance, and the samples used may not be representative of the antibody profile observed in patient populations.

WARNINGS AND PRECAUTIONS

This product can only be used by those who received professional training in vitro diagnostic tests. For in vitro diagnostic use This product has not been FDA cleared or approved but has been authorized for emergency use by the FDA under a EUA for use by authorized laboratories This product has been authorized only for detecting the presence of IgG antibodies to SARS-CoV-2, not for any other viruses or pathogens The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of 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 declaration is terminated or authorization is revoked sooner

SAFETY PRECAUTIONS

CAUTION

All samples and reagents containing human-derived substances should be regarded as potentially infectious and handled properly in accordance with appropriate regulations.

WARNING

Sulfuric acid in the stop solution is a hazardous substance and can cause severe burns and eye damage, so care must be taken when using it. This product contains sodium azide, which generates toxic gas when it reacts with acidic substances, and highly explosive metal azides when it reacts with lead or copper, so care must be taken when using it. When handling samples and reagents, take care not to let them get in contact with the skin, eyes, or mucous membranes by wearing safety glasses, protective clothing, and gloves. When contact is made, immediately wash with a large amount of water. Wash your hands thoroughly after each analysis. After the analysis, use purified water to clean the surface of the experiment table used, and disinfect with freshly prepared 0.5% sodium hypochlorite.

HANDLING PRECAUTIONS

Do not smoke or eat food while handling samples and test reagents. Do not pipette reagents by mouth, and it is recommended to use sterile disposable pipettes or disposable pipette tips. Do not reuse disposable items (tips, experimental gloves, tubes, etc.) and microwell plates. Reagents other than stop solutions and concentrated detergents should not be used in combination with reagents from other batches. Take care not to splatter aerosols when handling all samples and reagents. Dispose of in accordance with appropriate waste regulations. If the product packaging is damaged, or there is a leak in the reagent bottle, it should not be used because it can lead to misjudgment of results due to contamination or degradation. Take care not to mix it with other test reagents or to place a cap of another solution on it.

LIMITATIONS

A negative result for an individual subject indicates the absence of detectable anti-SARS-CoV-2 antibodies. Negative results do not preclude SARS- CoV-2 infection and should not be used as the sole basis for patient management decisions. A negative result can occur if the quantity of antibodies for the SARS-CoV-2 virus present in the specimen is below the detection limit of the assay, the antibodies that are detected are not present during the stage of disease in which a sample is collected or if the virus has undergone minor amino acid mutation(s) in the epitope recognized by the antibody used in the test. False-positive results may occur due to cross- reactivity from pre-existing antibodies or other possible causes. A positive result may not indicate previous SARS-CoV-2 infection. Consider other information, including clinical history and local disease prevalence, in assessing the need for a second but different serology test to confirm an immune response. Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E. Not for the screening of donated blood. It is not known at this time if the presence of antibodies to SARS-CoV-2 confers immunity to infection. Use of AdvanSure TM SARS-CoV-2 IgG(S1) ELISA is limited to laboratory personnel who have been trained. Not for home use.
This assay has not been evaluated with fingerstick specimens. This test is not authorized for use with fingerstick whole blood. The performance of this test has not been established in individuals who have received a COVID-19 vaccine. The clinical significance of a positive or negative antibody result following COVID-19 vaccination has not been established, and the result from this test should not be interpreted as an indication or degree of protection from infection after vaccination. The performance of this test was established based on the evaluation of a limited number of clinical specimens. The samples for the positive percent agreement study were collected between April 2020 and February 2021 in South Korea. The clinical performance has not been established in all circulating variants but is anticipated to be reflective of the prevalent variants in circulation at the time and location of the clinical evaluation. Performance at the time of testing may vary depending on the variants circulating, including newly emerging strains of SARS-CoV-2 and their prevalence, which change over time. This device should not be used to diagnose or exclude acute SARS-CoV-2 infection. Direct testing for SARS-CoV-2 with a molecular assay should be performed to evaluate acute infection in symptomatic individuals. Performance has only been established with the specimen types listed in the Intended Use. Other specimen types have not been evaluated and should not be used with this assay. The performance of this device has not been established in samples collected from individuals less than 15 days following the onset of symptoms. Samples should be collected from individuals greater than 14 days following the onset of symptoms. Samples should not be tested if collected from individuals less than 15 days post symptom onset. Results are not intended to be used as the sole basis for patient management decisions. Test results should be interpreted in conjunction with clinical observations, patient history, epidemiological information, and other laboratory findings. The presence of 500 mg/dL and higher concentrations of hemoglobin may result in potential false-positive results.

Conditions of Authorization for the Laboratory
The adventure TM SARS-CoV-2 IgG(S1) ELISA Letter of Authorization, along with the Authorized Fact Sheet for Healthcare Providers, the Authorized Fact Sheet for Recipients, and authorized labeling are available on the FDA website: https://www.fda.gov/medical-devices/coronavirus-disease-2019covid-19 -emergency-use-authorizations-medical-devices/in-vitro-diagnostics- euas. Authorized laboratories using the AdvanSure TM SARS-CoV-2 IgG(S1) ELISA must adhere to the Conditions of Authorization indicated in the Letter of Authorization as listed below:

1. Authorized laboratories* using the AdvanSure TM SARS-CoV-2 IgG(S1) ELISA must include with test result reports, all authorized Fact Sheets. Under exigent circumstances, other appropriate methods for disseminating Fact Sheets may be used, which may include mass media.
2. Authorized laboratories using the AdvanSure TM SARS-CoV-2 IgG(S1) ELISA must use the product as outlined in the authorized labeling. Deviations from the authorized procedures, including the authorized instruments, authorized clinical specimen types, authorized control materials, authorized other ancillary reagents and authorized materials required to use your product are not permitted.
3. Authorized laboratories that receive the AdvanSure TM SARS-CoV-2 IgG(S1) ELISA must notify the relevant public health authorities of their intent to run your product prior to initiating testing.
4. Authorized laboratories using the AdvanSure TM SARS-CoV-2 IgG(S1) ELISA must have a process in place for reporting test results to healthcare providers and relevant public health authorities, as appropriate.
5. Authorized laboratories must collect information on the performance of the adventure TM SARS-CoV-2 IgG(S1) ELISA and report to DMD/OHT7-OIR/OPEQ/CDRH (via email: CDRH-EUA-Reporting@fda.hhs.gov) and LG Chem, Ltd. (kellysp@lgchem.com) any suspected occurrence of false positive or false negative results and significant deviations from the established performance characteristics of which they become aware.
6. All laboratory personnel using the AdvanSure TM SARS-CoV-2 IgG(S1) ELISA must be appropriately trained in immunoassay techniques and use appropriate laboratory and personal protective equipment when handling this kit, and use this product in accordance with the authorized labeling. All laboratory personnel using the assay must also be trained in and be familiar with the interpretation of the results of the product.
7. LG Chem, Ltd., authorized distributors, and authorized laboratories using the AdvanSure TM SARS-CoV-2 IgG(S1) ELISA must ensure that any records associated with this EUA are maintained until otherwise notified by FDA. Such records will be made available to FDA for inspection upon request.

*The letter of authorization refers to, “Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform high complexity tests” as “authorized laboratories.”

SYMBOLS

References

• HHS Accessibility & Section 508 | HHS.gov

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