Instructions For Use (English)

 

 

Lumivi Diagnostics’™ SARS-CoV-2 IgG Rapid Test Kit

Instructions for Use

 

 

 

 

For in vitro diagnostic use


 

Intended Use:

The Lumivi Diagnostics’™ SARS CoV-2 IgG Rapid Test is a single use, rapid lateral flow chromatographic immunoassay intended for the qualitative detection of IgG antibodies to SARS-CoV-2 in plasma and serum. The test is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.  Currently, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity.  The Lumivi Diagnostics’™ SARS CoV-2 IgG Rapid Test is intended for use by laboratory personnel or other healthcare professionals.  The Lumivi Diagnostics’™ SARS CoV-2 IgG Rapid Test is for laboratory use only, not for point-of-care use.

  • This assay is not intended to be used for screening patients or as an aid for diagnosis of patients with suspected COVID-19 infection.
  • This assay is not intended for home testing (or self-testing).
  • Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions.
  • Negative results must be combined with clinical observations, patient history, and epidemiological information.
  • False negative results can occur in elderly and immunocompromised patients.
  • False positive results for IgG antibodies may occur due to cross-reactivity from pre-existing antibodies or other possible causes.

 

Summary and Explanation:

Lumivi Diagnostics’™ SARS CoV-2 IgG Rapid Test Kit is a lateral flow chromatographic immunoassay that is visually read (i.e., does not require instrumentation) and intended for qualitative detection of immunoglobulin (Ig)G antibodies to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in human serum and plasma (sodium citrate, sodium heparin, and EDTA). Currently, it is unknown how long antibodies persist following infection with SARS-CoV-2 and whether the presence of antibodies confers protective immunity. The SARS-CoV-2 IgG Rapid Test Kit should not be used to diagnose acute SARS-CoV-2 infection or Coronavirus Disease 2019 (COVID-19). This test is designed to detect IgG antibodies to SARS-CoV-2, which are generally detectable in a patient’s blood several days after initial infection, although the duration for which antibodies are detectable post-infection is not well characterized. The sensitivity of the SARS-CoV-2 IgG Rapid Test Kit early after infection (< 5 days) is unknown due to the variable time to seroconversion. Negative results do not preclude acute SARS-CoV-2 infection. If acute infection is suspected, direct testing for SARS-CoV-2 viral RNA or antigen is necessary. Zeta

Laboratory and healthcare professionals should follow regulatory requirements for reporting result(s).

The Lumivi Diagnostics’ SARS-CoV-2 IgG Rapid Test Kit is only for use under the Health Canada Interim Order (IO).

 

Principle:

Each Lumivi Diagnostics’™ SARS-CoV-2 IgG Rapid Test is individually packaged in a non-sterile foil pouch containing desiccant and a dropper bottle containing non-sterile Running Buffer. The sample is added to the sample well of the Test first and Running Buffer is added to the sample well right after the sample addition.

The sample will migrate by capillary action along the test cartridge. If anti-SARS-CoV-2 virus IgG is present in the sample, it binds to the SARS-CoV-2 recombinant protein present in the sample pad to form an immunocomplex. As the immunocomplex continues to migrate, it is captured by the monoclonal anti-human IgG line (IgG).

The test also contains an internal control line with immobilized polyclonal goat anti-rabbit IgG antibody. As the sample migrates from the conjugate pad, it will carry the rabbit IgG conjugate toward the internal control line that and is captured by the immobilized goat anti-rabbit IgG antibody. If no internal control line (CON) is observed, the test result is invalid, and the sample must be retested

The test line results are visible in the Test result window at 15 minutes. A visible pinkish-purple band in the CON area, with the absence of a visible pinkish-purple band in the IgG area, indicates that SARS-CoV-2 IgG antibody was not detected, and the test result is negative. The presence of a visible pinkish-purple band at the CON area and the presence of a distinct band in the "IgG" test area indicates that SARS-CoV-2 IgG antibody was detected, and the test result is positive.  Please refer to section “Interpretation of Results” for further details.

 

Reagents:

The Lumivi Diagnostics’™ SARS-CoV-2 IgG Rapid Test Kit is comprised of the following components:

  1. 25 x Lumivi Diagnostics’™ SARS-CoV-2 IgG Rapid Test
  2. 1 x 5 mL Running Buffer in a dropper bottle
  3. 1 x Instructions for Use (package Insert)

 

The product can be stored at 2–30°C.

 

Sample Collection and Preparation:

Plasma or serum may be used as samples for this procedure. For plasma, collect blood in a tube containing heparin, sodium citrate, or EDTA. If serum samples are to be used, collect the blood in a tube without anticoagulant and allow to clot for at least 20 minutes before centrifugation. Samples from patients who have been treated with anticoagulants may require a longer coagulation period; completion of the clotting process should be observed before centrifugation and should be established by each laboratory. After centrifugation, the clot does not need to be removed from serum samples before extracting an aliquot for testing. Plasma and serum samples should be stored at 2–8°C if not tested immediately. If the sample is not tested within 3 days, it should be stored at –20˚C for longer storage.  Sample collection, storage and processing is based on Public Health Ontario guidance for COVID-19 Serology samples (see reference below) and industry normal for serum and plasma collection and handling.

 

Materials Required but Not Included in the SARS-CoV-2 Rapid Test Kit:

  • Blood collection tube
    • Serum
    • Plasma (sodium citrate, sodium heparin, or EDTA)
  • Vortex mixer
  • Sample storage tubes
  • Desktop centrifuge (for blood collection tubes and small storage tubes)
  • Adjustable pipettes (15 μL)
  • Sterile pipette tips with filters
  • Powder free latex gloves
  • Timer

 

Procedure:

  1. Open the foil pouch, remove the Lumivi Diagnostics’™ SARS-CoV-2 IgG Rapid Test and place the Test on a level surface.
  2. Label the Test with the patient’s identification.
  3. Using a pipette, add 15 μL of patient sample (plasma or serum) into the sample well.
  4. Add 3 drops of Running Buffer into the sample well.
  5. The Test results are visible at 15 minutes. For interpretation of results, please see below.

 

Procedural Notes:

  • Do not use this product beyond the expiration date.
  • Wear protective clothing and disposable gloves while handling kit reagents and samples. All samples should be handled as if they are potentially infectious. Wash hands thoroughly after performing the test.
  • The results of the Test are invalid if total volumes (sample and running buffer) are < 100 μL or > 200 μL are used. These volumes may cause a lack of flow with the kit or overflow of the kit, respectively.
  • If serum or plasma samples have been stored in the refrigerator, allow them to return to room temperature and mix samples properly before testing.
  • For samples stored at -20°C, avoid multiple freeze-thaw cycles.
  • Do not use grossly hemolyzed or turbid samples for testing.
  • If the Lumivi Diagnostics’™ SARS-CoV-2 IgG Rapid Test was stored in the refrigerator, allow it to return to room temperature before testing.
  • The Lumivi Diagnostics’™ SARS-CoV-2 IgG Rapid Test should remain in its sealed pouch until ready to perform the test(s). Once opened, the test cassette/cartridge must be used within 1 hour.
  • Do not use the components of any other type of test kit as a substitute for the components in this kit.
  • Observe established procedures for proper disposal of samples and the used Test (biohazardous waste).

 

Interpretation of Results

 

  1. Negative (-)

A visible pinkish-purple band in the CON area, with the absence of a visible pinkish-purple band in the IgG area, indicates that the SARS-CoV-2 IgG antibody was not detected, and the test result is negative.

  1. Positive (+)

A visible pinkish-purple band in the CON area and a visible pinkish-purple band in the IgG area indicates that the SARS-CoV-2 IgG antibody was detected, and the test result is positive.

  1. Invalid

A visible pinkish-purple band in the CON area should always appear. If no visible pinkish-purple band is present in the CON area at 15-minutes, the Test is invalid, and the sample must be retested using a new Test.

 

 

Notes:

  • The results of the SARS-CoV-2 IgG Rapid Test are interpreted visually without the need for instrumentation.
  • No quantitative interpretation should be made based on the intensity and/or order of appearance of bands.
  • The intensity and order of appearance of the CON and IgG bands may vary in different samples.
  • Samples that showed negative results at 15 minutes must not be read after that time because weak bands may appear upon prolonged standing.
  • The color intensity of positive bands may change if the kit is left standing for a long period of time.

 

Limitations:

  • The results of the Lumivi Diagnostics’™ SARS-CoV-2 IgG Rapid Test are not intended to be used as an aid for diagnosis of patients with suspected SARS CoV-2 infection or for screening of donated blood.
  • The results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions.
  • Testing with a virus diagnostic technology should be performed to evaluate for active infection in symptomatic individuals.
  • The intensity of the test band is not necessarily correlated with SARS-CoV-2 antibody titer in the sample, and the results must be combined with clinical observations, patient history, and epidemiological information.
  • A negative result can occur if the quantity of antibodies for the SARS-CoV-2 virus present in the sample is below the detection limit of the Test, or the virus has undergone minor amino acid mutation(s) in the epitope recognized by the antibody detected by the Test.
  • False negative results can occur in elderly and immunocompromised patients.
  • 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 serology test to confirm an adaptive immune response.
  • False positive results may occur due to cross-reactivity from pre-existing antibodies or other possible causes.

 

This Test has been authorized only to detect the presence of IgG antibodies against SARS CoV-2, not for any other viruses or pathogens. This test has not been cleared or licensed by Health Canada; the test has been authorized by Health Canada under the IO. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of SARS-CoV-2/COVID-19 under unless the authorization is terminated or revoked sooner.

This product should only be used by a trained professional, and is not intended for home use, self-testing, or point of care use. The package insert must be read completely before performing the test. Failure to follow directions described in the package insert may yield inaccurate test results.

 

User Quality Control:

The presence of a band in the "CON" area acts as an internal positive procedural control to ensure valid performance of the test. In the absence of a band in the "CON" area, the test is invalid and must be repeated. In addition, if the test has been performed correctly and the Test is working properly, the background in the result window will become clear such that a result is distinct. This may be considered an internal negative procedural control. If a problem persists, contact IPOC Dx Technical Support Services for assistance.

 

Performance Characteristics

 

CLINICAL AGREEMENT STUDY:

 

Clinical patient samples serum or plasma (in EDTA, sodium heparin, or sodium citrate) samples were collected from 286 subjects for which 57 COVID-19 positive patients confirmed by an FDA authorized SARS-CoV-2 PCR test and 229 subjects were negative for SARS-CoV-2 prior to December 2019 (pre-pandemic). Testing of the clinical samples using the Lumivi Diagnostics’™ SARS-CoV-2 IgG Rapid Test Kit was conducted at International Point of Care, Toronto, Ontario, Canada.  The samples were randomized and blinded.

 

CLINICAL SENSITIVITY (Positive Percent Agreement – PPA)

 

Table 1 - Clinical Performance Results Summary – Sensitivity

 

 

 

Lumivi Diagnostics’™ SARS-CoV-2 IgG Rapid Test - Results

Days from diagnosis to sample retrieval

Number of samples tested

Total IgG antibody positive results

Total IgG antibody PPA

95% CI*

0-7 days

1

1

–

–

8-14 days

12

12

–

–

≥15 days

43

42

–

–

TOTAL

57

56

98.2%

90.7%, 99.7%

* Confidence interval (CI) for sensitivity and specificity were calculated per a score method described in CLSI EP12-A2 (2008)

 

CLINICAL SPECIFICITY (Negative Percent Agreement – NPA)

 

Table 2. -  Clinical Performance Results – Specificity

 

 

Lumivi Diagnostics’™ SARS-CoV-2 IgG Rapid Test - Results

Number of samples tested

Negative results

Overall NPA (95% CI)

229

225

98.2% (95.6%, 99.3%)

 

 

CROSS-REACTIVITY

Table 3 -

Virus/Bacteria/Parasite Antibody positive

Number of samples

Positive results

Negative results

Human coronavirus 229E

21

0

21

Human coronavirus OC43

18

0

18

Human coronavirus HKU1

11

0

11

Adenovirus

6

0

6

Parainfluenza virus 1-4

15

0

15

Influenza A

8

0

8

Influenza B

12

0

12

Human Metapneumovirus (hMPV)

5

1

4

Enterovirus

6

0

6

Respiratory syncytial virus

10

0

10

Rhinovirus

5

0

5

Epstein-Barr virus

13

0

13

Haemophilus influenza

12

0

12

Bordetella pertussis

3

0

3

HIV

5

1

4

HBV

6

0

6

Mycoplasma pneumonia

10

0

10

Chlamydia pneumonia

5

0

5

Anti-nuclear antibodies (ANA)

5

0

5

Human anti-mouse antibodies (HAMA)

5

0

5

 

CLASS SPECIFICITY

A class specificity study was conducted to demonstrate that the SARS- CoV-2 IgG Rapid Test Kit does not detect SARS- CoV-2 IgM antibodies. A negative plasma pool was spiked with recombinant human IgG or recombinant human IgM and run on the Lumivi Diagnostics’™ SARS-CoV-2 IgG Rapid Test.  The summary table reports the number of tests with a visible line over the total number of test run (i.e., 5 tests with positive control line over 5 tests would be reported as 5/5).

 

Sample

Control Line

Test Line

Recombinant Human IgG

5/5

5/5

Recombinant Human IgM

5/5

0/5

Control

2/2

0/2

The results reported for the study demonstrate that the Lumivi Diagnostics’™ SARS-CoV-2 IgG Rapid Test Kit is antibody class   specific.

 

 

INTERFERENCE

 

Interferent

Test concentration
(as per CLSI EP07, use 20×
where possible)

Result

 

Hemoglobin (low)

5 mg/mL

No interference

Hemoglobin (high)

10 mg/mL

No interference

Bilirubin (conjugated)

0.4 mg/mL

No interference

Albumin (protein)

213.5 mg/mL

No interference

Triglyceride (total)

21.5 mg/mL

No interference

Total IgM

1 mg/mL

No interference

Total IgG*

Not Applicable*

Not Applicable*

Rheumatoid factor

–

No interference

Anti-nuclear antibodies

–

No interference

Antibodies developed against protein expression system used to generate recombinant antigens

Murine anti-HEK293

1 mg/mL

No interference

Antibodies developed against protein expression system used to generate recombinant antigens

Murine anti-E. coli

1 mg/mL

No interference

Human anti-mouse antibodies

–

No interference

Acetaminophen

0.6 mg/mL

No interference

Acetylsalicylic acid

6 mg/mL

No interference

Ibuprofen

1 mg/mL

No interference

Ascorbic acid

0.21 mg/mL

No interference

 

 

HOOK EFFECT

 

Concentration of recombinant

Total positive result

0 ng/mL in low-positive plasma sample

0/3

250 ng/mL in low-positive plasma sample

0/3

500 ng/mL in low-positive plasma sample

3/3

1 mcg/mL in low-positive plasma sample

3/3

1.30 mcg/mL in low-positive plasma sample

3/3

3 mcg/mL in low-positive plasma sample

3/3

5 mcg/mL in low-positive plasma sample

3/3

10 mcg/mL in low-positive plasma sample

3/3

25 mcg/mL in low-positive plasma sample

3/3

65 mcg/mL in low-positive plasma sample

3/3

65 mcg/mL in high-positive plasma sample

3/3

 

 

 

Trademarks Used in this Document

Lumivi Diagnostics LP™

 

 

References

https://www.publichealthontario.ca/en/laboratory-services/test-information-index/covid-19-serology