covid-19 human igm igg rapid test€¦ · testing strips (20) colloidal gold-labeled covid-19...

1 PP-PLM-A-080 v1.0

COVID-19 Human IgM IgG Rapid Test Instructions For Use

INTENDED USE

This product is a lateral flow chromatographic immunoassay for rapid, qualitative detection of human IgM and IgG antibodies against COVID-19 virus in human venous whole blood (dipotassium EDTA, sodium heparin, sodium citrate), serum, plasma (dipotassium EDTA, sodium heparin, sodium citrate), and finger prick whole blood (dipotassium EDTA, tripotassium EDTA, no anticogulant). Abnova COVID-19 Human IgM IgG Rapid Test is intended for use as an aid in identifying individuals with immune response to SARS-CoV-2 indicating recent or prior infection. It is unknown how long antibodies persist following infection and if the presence of antibodies confer protective immunity. It should not be used to diagnose acute SARS-CoV-2 infection.

This test is limited to testing in laboratories certified under Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a that meets the requirements to perform moderate or high complexity tests. This test is also authorized for use with finger prick whole blood (dipotassium EDTA, tripotassium EDTA, no anticogulant) at the Point of Care (POC), for example in patient care setting under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.

Positive results demonstrate IgM and/or IgG antibodies to SARS-CoV-2 detectable in blood several days after initial infection. All positive results should be reported to the appropriate public health authorities. Negative results do not preclude acute SARS-CoV-2 infection and should be confirmed with a FDA authorized molecular assay. False positive results may occur due to cross-reactivity from pre-existing antibodies or other possible causes, and should be confirmed using a second, different IgM IgG assay.

BACKGROUND

In 2019, a novel coronavirus was identified as the cause of an outbreak of severe respiratory disease in China. On February 11, 2020, the disease was officially named “Coronavirus Disease 2019” (COVID-19).

1 As the first line of defense against viral

infection, human IgM antibody is generated when one becomes infected with the COVID-19 virus. The level of IgM will rise within 2 weeks and then drop; accordingly, a second antibody IgG, which is more protective than IgM antibody, develops within 4 weeks.

2 Results from antibody testing should not be used as the sole basis to

diagnose or exclude COVID-19 infection or to inform infection status.

PRINCIPLE OF THE TEST

Abnova COVID-19 Human IgM IgG Rapid Test utilizes the technique of chromatography and qualitative immunoassay to detect the presence of IgM and IgG antibodies against COVID-19 virus in human venous whole blood, serum, plasma, and finger prick whole blood. During testing, the blood sample firstly interacts with COVID-19 protein antigens labeled gold nanoparticles in the Sample Zone. By capillary action, the mixed sample flows across the membrane strip. Human IgM antibodies interact with the anti-human IgM antibodies coated in the Result Zone showing a visible colored line. Similarly, a colored line in the IgG test zone demonstrates the presence of human IgG antibodies. Control line must appear every time to ensure the quality of the sample processing.

MATERIALS AND REAGENTS PROVIDED

Abnova COVID-19 Human IgM IgG Rapid Test contains Instruction for Use, COVID-19 Testing Strip, and Sample Buffer.

20 Test Kit:

Testing Strips (20)

Colloidal Gold-Labeled COVID-19 Nucleocapsid (N) Protein

Colloidal Gold-Labeled COVID-19 Receptor-Binding Domain (RBD) Protein

Colloidal Gold-Labeled Chicken IgY Antibody with less than 0.1% Sodium Azide

Goat Anti-Human IgM Antibody

Goat Anti-Human IgG Antibody

Goat Anti-Chicken IgY Antibody with less than 0.1% Sodium Azide

Sample Buffers (20)

Testing Strip Sample Buffer

The Result Zone and Sample Zone of COVID-19 Testing Strip are shown below:

MATERIALS REQUIRED BUT NOT PROVIDED

Tube rack for blood collection tubes

Timer or watch

Personal protective equipments

Minivette® POCT 20µL K3E (Cat# 17.2113.020, Sarstedt)

End-to-End Capillary 20µl K2E (Cat# 19.447, Sarstedt)

Micro Collector no anticoagulant (Cat# U0399, Abnova)

BD Vacutainer® K2E (EDTA) 18.0mg Plus Blood Collection Tube (Cat#

367525, BD)

BD Vacutainer® Sodium Heparin (NH) 75USP Units Blood Collection Tube

(Cat# 367871, BD)

BD Vacutainer® Buffered Sodium Citrate (9NC) Blood Collection Tube (Cat# 363080, BD)

BD Vacutainer® Serum Blood Collection Tube (Cat# 367815, BD)

EXPIRATION DATE

Date of manufacture, expiration date and lot number are indicated on the packaging. Expiration date is 12 months after the date of manufacture.

STORAGE ENVIRONMENT

Store kit at room temperature 15°C - 30°C (59°F - 86°F) and avoid direct exposure to sunlight

Do not freeze or store the kit outside the temperature range described above.

Do not open the kit until ready to use.

Do not use the kit after the expiration date.

WARNING AND PRECAUTIONS

For in vitro diagnostic use only.

This test has not been US FDA approved but authorized under EUA for CLIA-certified laboratories or POC under CLIA Certification of Waiver, Certificate of Compliance, and Certificate of Accreditation.

This test has been authorized only for detection of antibodies from SARS-CoV-2, not for any other viruses or pathogens.

Do not use the kit contents beyond the expiration date printed on the outside of the box.

Test results are visually determined.

Processed the collected blood as indicated in the procedure section to avoid false test results.

Use ONLY THE SAMPLE BUFFER supplied in the kit.

Do not reuse any kit components.

This kit is NOT INTENDED for testing liquid sample such as wash or aspirate samples or sample in transport media.

Testing should be performed in an area with adequate ventilation.

Sodium azide which is harmful if inhaled, swallowed, or exposed to skin. Wash with plenty of water if contact with the skin.

Standard precautions and institutional guidelines should be followed in handling, storing, and disposing of all specimens and all blood and bodily fluids.

Wear protective clothing, glove, and eye/face protection when handling the content of this kit.

Wash hands thoroughly after handling.

Humidity and temperature can adversely affect results.

For additional information on hazard symbols, safety, and handling, and disposal of the components within this kit, please refer to the Safety Data Sheet (SDS) located at www.abnova.com.

Sample Zone (drop blood sample here)

Result Zone C: Control line M: IgM line G: IgG line

DC0301

2 PP-PLM-A-080 v1.0

SAMPLE REQUIREMENT

Whole blood sample should be used fresh. Serum and plasma sample can be stored at 2°C - 8°C for no more than one week. Bring serum and plasma back to room temperature (15°C - 30°C) 15 minutes before use.

VENOUS WHOLE BLOOD, SERUM AND PLASMA TEST PROCEDURE

1. Take out COVID-19 Testing Strip and Sample Buffer, and adjust to room temperature (15°C - 30°C).

2. Place the COVID-19 Testing Strip on a balanced surface.

3. Take 20 μL whole blood, 10μL serum or 10μL plasma with a pipette, and drop the sample into the Sample Zone of the COVID-19 Testing Strip (DO NOT drop the sample into the Result Zone).

4. Wait until the sample has fully penetrated the Sample Zone. Add 4 drops of Sample Buffer vertically to the Sample Zone. (DO NOT drop the Sample Buffer into the Result Zone).

5. Wait up to15 minutes for the colored line(s) to appear and then read the result at 15 minutes (DO NOT read after 20 minutes).

FINGER PRICK WHOLE BLOOD TEST PROCEDURE

1. Twist off the protective cap of the 23G lancet (Cat# 9087, ApexBio Disposable Safety Blood Lancet, ApexBio) and pull it straight out.

2. Clean the fingertip with an alcohol swab. Press the lancet against the puncture site and press the push-button to activate the device.

3. Use the collector (Cat# 17.2113.020, Minivette® POCT 20µL K3E, Sarstedt, Cat# 19.447, End-to-End Capillary 20µl K2E, Sarstedt, Cat# U0399, Micro Collector no anticogulant) to collect the finger prick blood

For the Minivette® K3E or Micro Collector, hold the collector in a horizontal, slightly inclined position. The air ventilation hole at the

end of the piston should not be covered, nor should the piston be completely pushed down. Collect 20μL fresh blood using the entire capillary tip ensuring no air bubbles present.

For the End-to-End Capillary, use the entire capillary to collect 20 μL of fresh blood horizontally. DO NOT move the capillary until it is filled end-to-end with the 20 μL blood sample.

4. Add the blood samples to the Sample Zone of the COVID-19 Testing Strip. (DO NOT unload the sample into the Result Zone)

For the Minivette® K3E or Micro Collector, slightly press down the piston to smoothly dispense the blood sample into the Sample Zone.

For the End-to-End Capillary, hold the capillary vertically to fully touch the Sample Zone. DO NOT move the capillary until the entire blood sample flows into the Sample Zone.

5. Wait until the blood has fully penetrated the Sample Zone. Add 4 drops of Sample Buffer* vertically to the Sample Zone. (DO NOT drop the Sample Buffer into the result zone).

6. Wait up to 15 minutes for the colored line(s) to appear and then read the result at 15 minutes (DO NOT read after 20 minutes).

3 PP-PLM-A-080 v1.0

TEST LIMITATIONS

1. Use of Abnova COVID-19 Human IgM IgG is limited to laboratory personnel who have been trained. Not for home use.

2. This product can only be used to detect the IgG and IgM antibodies of the novel SARS-CoV-2 coronavirus in human venous whole blood, serum, plasma, and finger prick whole blood. It cannot be used with other body fluids or secretions.

3. This product is only for qualitative testing and the specific content of each indicator must be measured using other quantitative methodologies.

4. For optimal test performance, proper sample collection is critical. Failure to follow the procedure may give inaccurate results.

5. Reading test results earlier than 15 minutes after the addition of Sample Buffer may yield erroneous results. Do not interpret the results after 20 minutes.

6. Add incorrect drops of Sample Buffer may lead to erroneous results.

7. In the early onset of symptom, anti-SARS-CoV-2 IgM and IgG antibody concentration maybe below detectable levels.

8. SARS-CoV-2 IgG antibodies may be below detectable levels in patients who have been exhibiting symptoms for less than 14 days.

9. Results from immunosuppressed patients should be interpreted with caution.

10. 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.

11. Negative results may be caused by low concentrations of the novel SARS-CoV-2 coronavirus IgM and IgG antibody in the sample and therefore cannot completely rule out the possibility of infection.

12. False positive results for IgM and IgG antibodies may occur due to cross-reactivity from pre-existing antibodies or other possible causes.

13. False negative results may occur if the viral antigen is below the detection limit of the test or if sample was collected improperly.

14. The results of this test are for clinical reference only and should not be the only basis to diagnose, to exclude SARS-CoV-2 infection or to inform infection status. Results should be used in combination with clinical observations and other testing methods.

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

INTERPRETATION OF RESULTS

Result zone of the COVID-19 Testing Strip indicates human IgM line (M line), IgG line (G line) and control line (C line). C line must appear to ensure the quality of sample processing. Please refer to the diagram below for interpretation:

Note: Report all positive results to the appropriate public health authorities. For invalid results, review the procedure and repeat the procedure with a new test. If the problem persists, discontinue using the test kit and contact local distributors and Abnova.

QUALITY CONTROL

The internal positive control line validates the immunological integrity of the testing strips, proper reagent function, and assures correct test procedure.

The internal controls do not assess proper sample collection technique.

NOTIFICATION

Clinical laboratories and healthcare providers must include this information in their patient test report:

1. This test is limited to testing in laboratories or by healthcare workers. It is considered as a high complexity test by default under CLIA requirements.

2. Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals.

3. Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.

4. 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.

PERFORMANCE CHARACTERISTICS

Reactivity:

COVID-19 nucleocapsid (N) humanized IgM and IgG antibodies validated against SARS-CoV, COVID-19, MERS-CoV, and HCoV-NL63 nucleocapsid proteins demonstrating SARS-CoV and COVID-19 specificity.

Nucleocapsid Protein

COVID-19 Nucleocapsid Humanized IgM Antibody

COVID-19 Nucleocapsid Humanized IgG Antibody

SARS-CoV N + +

COVID-19 N + +

MERS-CoV N - -

HCoV-NL63 N - -

COVID-19 receptor-binding domain (RBD) humanized IgM and IgG antibodies validated against SARS-CoV, COVID-19, MERS-CoV, and HCoV-NL63 RBD proteins demonstrating SARS-CoV and COVID-19 specificity.

RBD Protein COVID-19 RBD

Humanized IgM Antibody COVID-19 RBD

Humanized IgG Antibody

SARS-CoV RBD + +

COVID-19 RBD + +

MERS-CoV RBD - -

HCoV-NL63 RBD - -

COVID-19 humanized IgM and IgG nucleocapsid (N) and RBD antibodies were spiked in decreasing concentrations in K2-EDTA vs. Minivette® K3E normal venous whole blood samples demonstrating class-specific reactivity, repeatability, and limit of detection (LoD) sensitivity.

Spiked

Concentration Result

(IgM/IgG) Expected

Result Result

Agreement

COVID-19 Humanized N IgM Antibody Spiked

(K2-EDTA)

100 μg/mL +/-

+/-

100% (3/3)

50 μg/mL +/- 100% (3/3)

20 μg/mL +/- 100% (20/20)

COVID-19 Humanized N IgG Antibody Spiked

(K2-EDTA)

200 μg/mL -/+

-/+

100% (3/3)

100 μg/mL -/+ 100% (3/3)

50 μg/mL -/+ 100% (20/20)

COVID-19 Humanized N IgM Antibody Spiked

(Minivette® K3E)

100 μg/mL +/-

+/-

100% (3/3)

50 μg/mL +/- 100% (3/3)

20 μg/mL +/- 100% (20/20)

COVID-19 Humanized N IgG Antibody Spiked

(Minivette® K3E)

200 μg/mL -/+

-/+

100% (3/3)

100 μg/mL -/+ 100% (3/3)

50 μg/mL -/+ 100% (20/20)

COVID-19 Humanized S IgM Antibody Spiked

(K2-EDTA)

200 μg/mL +/-

+/-

100% (3/3)

100 μg/mL +/- 100% (3/3)

50 μg/mL +/- 100% (20/20)

COVID-19 Humanized S IgG Antibody Spiked

(K2-EDTA)

400 μg/mL -/+

-/+

100% (3/3)

200 μg/mL -/+ 100% (3/3)

10 μg/mL -/+ 100% (20/20)

COVID-19 Humanized S IgM Antibody Spiked

(Minivette® K3E)

200 μg/mL +/-

+/-

100% (3/3)

100 μg/mL +/- 100% (3/3)

50 μg/mL +/- 100% (20/20)

COVID-19 Humanized S IgG Antibody Spiked

(Minivette® K3E)

400 μg/mL -/+

-/+

100% (3/3)

200 μg/mL -/+ 100% (3/3)

10 μg/mL -/+ 100% (20/20)

4 PP-PLM-A-080 v1.0

Cross-Reactivity:

75 known negative K2-EDTA venous vs. Minivette® K3E finger prick whole blood samples were collected and tested for COVID-19 cross reactivity from a Taiwan population with minimal COVID-19 outbreak and a high prevalence of vaccination against and or infection with Influenza A, B, HBV, HCV, Haemophilus Influenza, alpha and beta 229E, NL63, OC43, HKU1 (non-COVID-19) Coronavirus.

No Sample ID EDTA Venous Blood Result

(IgM/IgG)

EDTA Finger Blood Result

(IgM/IgG)

Expected Result

(IgM/IgG)

Result Agreement

1 N76 -/- -/- -/- yes

2 N78 -/- -/- -/- yes

3 N27 -/- -/- -/- yes

4 N29 -/- -/- -/- yes

5 N7 -/- -/- -/- yes

6 N77 -/- -/- -/- yes

7 N8 -/- -/- -/- yes

8 N4 -/- -/- -/- yes

9 N25 -/- -/- -/- yes

10 N79 -/- -/- -/- yes

11 N74 -/- -/- -/- yes

12 N16 -/- -/- -/- yes

13 N17 -/- -/- -/- yes

14 N28 -/- -/- -/- yes

15 N26 -/- -/- -/- yes

16 N13 -/- -/- -/- yes

17 N72 -/- -/- -/- yes

18 N21 -/- -/- -/- yes

19 N22 -/- -/- -/- yes

20 N80 -/- -/- -/- yes

21 N81 -/- -/- -/- yes

22 N3 -/- -/- -/- yes

23 N82 -/- -/- -/- yes

24 N83 -/- -/- -/- yes

25 N24 -/- -/- -/- yes

26 N59 -/- -/- -/- yes

27 N63 -/- -/- -/- yes

28 N15 -/- -/- -/- yes

29 N14 -/- -/- -/- yes

30 N73 -/- -/- -/- yes

31 N5 -/- -/- -/- yes

32 N75 -/- -/- -/- yes

33 N58 -/- -/- -/- yes

34 N19 -/- -/- -/- yes

35 N84 -/- -/- -/- yes

36 N30 -/- -/- -/- yes

37 N20 -/- -/- -/- yes

38 N85 -/- -/- -/- yes

39 N86 -/- -/- -/- yes

40 N1 -/- -/- -/- yes

41 N11 -/- -/- -/- yes

42 N31 -/- -/- -/- yes

43 N87 -/- -/- -/- yes

44 N88 -/- -/- -/- yes

45 N89 -/- -/- -/- yes

46 N90 -/- -/- -/- yes

47 N91 -/- -/- -/- yes

48 N92 -/- -/- -/- yes

49 N38 -/- -/- -/- yes

50 N61 -/- -/- -/- yes

51 N93 -/- -/- -/- yes

52 N94 -/- -/- -/- yes

53 N60 -/- -/- -/- yes

54 N37 -/- -/- -/- yes

55 N35 -/- -/- -/- yes

56 N34 -/- -/- -/- yes

57 N42 -/- -/- -/- yes

58 N56 -/- -/- -/- yes

59 N51 -/- -/- -/- yes

60 N43 -/- -/- -/- yes

61 N95 -/- -/- -/- yes

62 N50 -/- -/- -/- yes

63 N40 -/- -/- -/- yes

64 N47 -/- -/- -/- yes

65 N41 -/- -/- -/- yes

66 N55 -/- -/- -/- yes

67 N32 -/- -/- -/- yes

68 N45 -/- -/- -/- yes

69 N39 -/- -/- -/- yes

70 N46 -/- -/- -/- yes

71 N96 -/- -/- -/- yes

72 N97 -/- -/- -/- yes

73 N98 -/- -/- -/- yes

74 N99 -/- -/- -/- yes

75 N100 -/- -/- -/- yes

Class Specificity:

COVID-19 humanized IgM and IgG nucleocapsid (N) antibodies were spiked in increasing concentrations in K2-EDTA vs. Minivette® K3E normal venous whole blood samples demonstrating class-specific reactivity and repeatability.

Spiked


(IgM/IgG)

Expected Result

(IgM/IgG)

Result Agreement

K2-EDTA Normal Venous Whole Blood Only

N/A -/- -/- 100% (2/2)

COVID-19 humanized IgM N Antibody Spiked in K2-

EDTA Normal Venous Whole Blood

20 μg/mL +/- +/- 100% (2/2)

50 μg/mL +/- +/- 100% (2/2)

100 μg/mL +/- +/- 100% (2/2)

Minivette® K3E Normal Venous Whole Blood Only

N/A -/- -/- 100% (2/2)

COVID-19 humanized IgM N Antibody Spiked in Minivette® K3 Normal Venous Whole Blood

20 μg/mL +/- +/- 100% (2/2)

50 μg/mL +/- +/- 100% (2/2)

100 μg/mL +/- +/- 100% (2/2)

Spiked


(IgM/IgG)

Expected Result

(IgM/IgG)

Result Agreement

K2-EDTA Normal Venous Whole Blood Only

N/A -/- -/- 100% (2/2)

COVID-19 humanized IgG N Antibody Spiked in K2-

EDTA Normal Venous Whole Blood

50 μg/mL -/+ -/+ 100% (2/2)

100 μg/mL -/+ -/+ 100% (2/2)

200 μg/mL -/+ -/+ 100% (2/2)

Minivette® K3E Normal Venous Whole Blood Only

N/A -/- -/- 100% (2/2)

COVID-19 humanized IgG N Antibody Spiked in

Minivette® K3E Normal Venous Whole Blood

50 μg/mL -/+ -/+ 100% (2/2)

100 μg/mL -/+ -/+ 100% (2/2)

200 μg/mL -/+ -/+ 100% (2/2)

Precision:

Day, operator, humanized nucleocapsid (N) IgM and IgG antibody concentration and kit lot# of COVID-19 Human IgM IgG Rapid Test repeatability and reproducibility study in K2-EDTA vs. Minivette® -K3E venous whole blood.

K2-EDTA Venous Whole Blood

Time Operator Sample Spiked

IgM or IgG Concentration

Kit Lot

Result (IgM/IgG) Expected

Result (IgM/IgG)

Result Agreement

Viewer 1

Viewer 2

Viewer 1

Viewer 2

Day 1

A

K2-EDTA Venous

Whole Blood 0

K9241-DC

-/- -/- -/- 100% (2/2)

100% (2/2)

COVID-19 Humanized N IgM Antibody Spiked in K2-EDTA Venous Whole Blood

20 μg/mL K9241-

DC low+/- low+/- low+/-

100% (2/2)

100% (2/2)

50 μg/mL K9241-

DC moderate+/- moderate+/- moderate+/-

100% (2/2)

100% (2/2)

COVID-19 Humanized N IgG Antibody Spiked in K2-EDTA Venous Whole Blood

50 μg/mL K9241-

DC -/ low+ -/ low+ -/ low+

100% (2/2)

100% (2/2)

100 μg/mL K9241-

DC -/ moderate+ -/ moderate+ -/ moderate+

100% (2/2)

100% (2/2)

Day 1

B

K2-EDTA Venous

Whole Blood 0

K9241-DC

-/- -/- -/- 100% (2/2)

100% (2/2)


20 μg/mL K9241-


100% (2/2)

100% (2/2)

50 μg/mL K9241-


100% (2/2)

100% (2/2)


50 μg/mL K9241-


100% (2/2)

100% (2/2)

100 μg/mL K9241-


100% (2/2)

100% (2/2)

Day 2

A

K2-EDTA Venous

Whole Blood 0

K9242-DC

-/- -/- -/- 100% (2/2)

100% (2/2)


20 μg/mL K9242-


100% (2/2)

100% (2/2)

50 μg/mL K9242-


100% (2/2)

100% (2/2)


50 μg/mL K9242-


100% (2/2)

100% (2/2)

100 μg/mL K9242-


100% (2/2)

100% (2/2)

Day 2

B

K2-EDTA Venous

Whole Blood 0

K9242-DC

-/- -/- -/- 100% (2/2)

100% (2/2)


20 μg/mL K9242-


100% (2/2)

100% (2/2)

50 μg/mL K9242-


100% (2/2)

100% (2/2)

5 PP-PLM-A-080 v1.0


50 μg/mL K9242-


100% (2/2)

100% (2/2)

100 μg/mL K9242-


100% (2/2)

100% (2/2)

Day 3

A

K2-EDTA Venous

Whole Blood 0

K9243-DC

-/- -/- -/- 100% (2/2)

100% (2/2)


20 μg/mL K9243-


100% (2/2)

100% (2/2)

50 μg/mL K9243-


100% (2/2)

100% (2/2)


50 μg/mL K9243-


100% (2/2)

100% (2/2)

100 μg/mL K9243-


100% (2/2)

100% (2/2)

Day 3

B

K2-EDTA Venous

Whole Blood 0

K9243-DC

-/- -/- -/- 100% (2/2)

100% (2/2)


20 μg/mL K9243-


100% (2/2)

100% (2/2)

50 μg/mL K9243-


100% (2/2)

100% (2/2)


50 μg/mL K9243-


100% (2/2)

100% (2/2)

100 μg/mL K9243-


100% (2/2)

100% (2/2)

Minivette® K3E Venous Whole Blood

Time Operator Sample Spiked

IgM or IgG Concentration

Kit Lot

Result (IgM/IgG) Expected

Result (IgM/IgG)

Result Agreement

Viewer 1

Viewer 2

Viewer 1

Viewer 2

Day 1

A


0 K9241-

DC -/- -/- -/-

100% (2/2)

100% (2/2)

COVID-19 Humanized N IgM Antibody

Spiked in Minivette®

K3E Venous Whole Blood

20 μg/mL K9241-


100% (2/2)

100% (2/2)

50 μg/mL K9241-


100% (2/2)

100% (2/2)

COVID-19 Humanized N IgG Antibody

Spiked in Minivette® K3E Finger Prick Whole

Blood

50 μg/mL K9241-


100% (2/2)

100% (2/2)

100 μg/mL K9241-


100% (2/2)

100% (2/2)

Day 1

B


0 K9241-

DC -/- -/- -/-

100% (2/2)

100% (2/2)




20 μg/mL K9241-


100% (2/2)

100% (2/2)

50 μg/mL K9241-


100% (2/2)

100% (2/2)




50 μg/mL K9241-


100% (2/2)

100% (2/2)

100 μg/mL K9241-


100% (2/2)

100% (2/2)

Day 2

A


0 K9242-

DC -/- -/- -/-

100% (2/2)

100% (2/2)




20 μg/mL K9242-


100% (2/2)

100% (2/2)

50 μg/mL K9242-


100% (2/2)

100% (2/2)




50 μg/mL K9242-


100% (2/2)

100% (2/2)

100 μg/mL K9242-


100% (2/2)

100% (2/2)

Day 2

B


0 K9242-

DC -/- -/- -/-

100% (2/2)

100% (2/2)




20 μg/mL K9242-


100% (2/2)

100% (2/2)

50 μg/mL K9242-


100% (2/2)

100% (2/2)




50 μg/mL K9242-


100% (2/2)

100% (2/2)

100 μg/mL K9242-


100% (2/2)

100% (2/2)

Day 3

A


0 K9243-

DC -/- -/- -/-

100% (2/2)

100% (2/2)




20 μg/mL K9243-


100% (2/2)

100% (2/2)

50 μg/mL K9243-


100% (2/2)

100% (2/2)




50 μg/mL K9243-


100% (2/2)

100% (2/2)

100 μg/mL K9243-


100% (2/2)

100% (2/2)

Day 3

B


0 K9243-

DC -/- -/- -/-

100% (2/2)

100% (2/2)




20 μg/mL K9243-


100% (2/2)

100% (2/2)

50 μg/mL K9243-


100% (2/2)

100% (2/2)




50 μg/mL K9243-


100% (2/2)

100% (2/2)

100 μg/mL K9243-


100% (2/2)

100% (2/2)

Matrix Equivalency:

COVID-19 humanized nucleocapsid (N) IgM and IgG antibodies were spiked in increasing concentrations in K2-EDTA, sodium heparin, sodium citrate venous whole blood vs. K2-EDTA, sodium heparin, sodium citrate plasma vs. serum vs. Minivette® K3E, Micro Collector (no anticoagulant), and End-to-End Capillary K2E venous whole blood from 5 normal individuals with replicated results read by two blinded, independent viewers demonstrating matrix equivalency.

Sample ID: N29, N31, N15, N58, N14

Matrix

Spiked IgM or IgG

Concentration

Result (IgM/IgG)

Expected Result

(IgM/IgG)

Result Agreement

COVID-19 Humanized N IgM Antibody Spiked in Normal Sample COVID-19 Humanized N IgM Antibody Spiked in Normal Sample


0 μg/mL

-/-

-/-

100% (10/10)

K2-EDTA Venous Plasma

-/- 100%

(10/10)

Sodium Heparin Venous Whole Blood

-/- 100%

(10/10)

Sodium Heparin Venous Plasma

-/- 100%

(10/10)

Sodium Citrate Venous Whole Blood

-/- 100%

(10/10)

Sodium Citrate Venous Plasma

-/- 100%

(10/10)

Venous Serum

-/- 100%

(10/10)


-/- 100%

(10/10)

Micro Collector Venous Whole Blood

-/- 100%

(10/10)

End-to-End

Capillary K2E

Venous Whole Blood

-/- 100%

(10/10)


20 μg/mL

low+/-

+/-

100% (10/10)


low+/- 100%

(10/10)


low+/- 100%

(10/10)


low+/- 100%

(10/10)


low+/- 100%

(10/10)


low+/- 100%

(10/10)

Venous Serum

low+/- 100%

(10/10)


low+/- +/- 100%

(10/10)

6 PP-PLM-A-080 v1.0


low+/- 100%

(10/10)

End-to-End

Capillary K2E

Venous Whole Blood

low+/- 100%

(10/10)


50 μg/mL

moderate+/-

+/-

100% (10/10)


moderate+/- 100%

(10/10)


moderate+/- 100%

(10/10)


moderate+/- 100%

(10/10)


moderate+/- 100%

(10/10)


moderate+/- 100%

(10/10)

Venous Serum

moderate+/- 100%

(10/10)


moderate+/- 100%

(10/10)


moderate+/- 100%

(10/10)

End-to-End

Capillary Venous Whole Blood

moderate+/- 100%

(10/10)

COVID-19 Humanized N IgG Antibody Spiked in Normal Sample


0 μg/mL

-/-

-/-

100% (10/10)


-/- 100%

(10/10)


-/- 100%

(10/10)


-/- 100%

(10/10)


-/- 100%

(10/10)


-/- 100%

(10/10)

Venous Serum

-/- 100%

(10/10)


-/- 100%

(10/10)


-/- 100%

(10/10)

End-to-End


-/- 100%

(10/10)


50 μg/mL

-/ low+

-/+

100% (10/10)


-/ low+ 100%

(10/10)


-/ low+ 100%

(10/10)


-/ low+ 100%

(10/10)


-/ low+ 100%

(10/10)


-/ low+ 100%

(10/10)

Venous Serum

-/ low+ 100%

(10/10)

Minivette® K3E

Venous Whole Blood

-/ low+ 100%

(10/10)


-/ low+ 100%

(10/10)

End-to-End


-/ low+ 100%

(10/10)


100 μg/mL

-/ moderate+

-/+

100% (10/10)


-/ moderate+ 100%

(10/10)


-/ moderate+ 100%

(10/10)


-/ moderate+ 100%

(10/10)


-/ moderate+ 100%

(10/10)


-/ moderate+ 100%

(10/10)

Venous Serum

-/ moderate+ 100%

(10/10) Minivette® K3E Venous Whole Blood

-/ moderate+ 100%

(10/10)


-/ moderate+ 100%

(10/10)

End-to-End


-/ moderate+ 100%

(10/10)

SYMBOLS

Do not reuse Do not use if package

is damaged

Temperature limit:

15°C - 30°C

Consult instruction for use

Manufacturer

Catalog number

Lot number Use by date Date of manufacture

ADVERSE EVENTS

Reporting Adverse Events, including problems with test performance or results, to Abnova by submitting the online Adverse Events Form.

(http://www.abnova.com/support/AdverseEvents.asp)

REFERENCES

1. Centers for Disease Control and Prevention. About COVID-19. https://www.cdc.gov/coronavirus/2019-ncov/cdcresponse/about-COVID-19.html

2. Jacofsky et al. Understanding Antibody Testing for COVID-19. J

Arthroplasty. 2020 Jul; 35(7): S74–S81.

Abnova (Taiwan) Corporation Neihu Plant 9th Fl., No.112 & No.114, Jhouzih St., Neihu District, Taipei City , Taiwan, R.O.C.

mdi Europa GmbH Langenhagener St. 71, D-30855 Langenhagen, Germany

http://www.abnova.com/support/AdverseEvents.asp

https://www.cdc.gov/coronavirus/2019-ncov/cdcresponse/about-COVID-19.html

https://www.cdc.gov/coronavirus/2019-ncov/cdcresponse/about-COVID-19.html

covid-19 human igm igg rapid test€¦ · testing strips (20) colloidal gold-labeled covid-19...

Documents