SARS-Cov2 Neutralizing Antibody Rapid Test

• Customization: Available
• Type: Detection Card
• Syringe: None
• Model NO.: HCOV018N
• Breathing Pattern: None
• Animal Anesthesia Machine Control Method: None
• Assay Time: 5-10 Minutes
• Delivery Time: 3~5days After Get Payment
• Payment: T/T, Western Union, Paypal
• Customized: Accpet
• Transport Package: Carton
• Specification: 10Tests/Kit
• Trademark: PETX
• Origin: Hangzhou
• HS Code: 38220010
• Production Capacity: 5000000PCS/Year

Product Description

INTENDED USE
The SARS-CoV2 Neutralizing Antibody Rapid Test is a rapid chromatographic immunoassay for the qualitative or quantitative detection of neutralizing antibodies to SARS-CoV2 in whole blood, serum, or plasma.

MATERIALS

For serum or plasma (quantitative)
Materials Provided

1. Foil pouches, with test cassettes
2. Calibrator card
3. Assay Buffer
4. Instruction for use

Materials Required But Not Provided

1. Micropipette and tips
2. Timer

For fingerpick whole blood (semi-quantitative or qualitative)
Materials Provided

1. Foil pouches, with test cassettes
2. Calibrator card
3. Assay buffer
4. Blood Lancet for Single Use
5. Iodine swab
6. Instruction for use

Materials Required But Not Provided

1. Mocropipette and tips (for semi-quantitative only)
2. Timer

TEST PROCEDURE

Allow the test device, specimen, buffer, and/or controls to equilibrate to room temperature (15-30°C) prior to testing.

1. Bring the pouch to room temperature before opening. Remove the test device from the sealed pouch and use it as soon as possible.
2. Place the test device on a clean and horizontal surface.                                                                                                                                       A.For Serum or Plasma Specimens (quantitative):

Use a pipette to collect the serum or plasma. Use the pipette to transfer 25mL of the specimen into the specimen well (S) of the test device, then add exactly 75mL of buffer into the specimen well and start the timer.

1. For Fingerpick Whole Blood Specimens (semi-quantitative):

B.To use a micropipette: Hold the pipette vertically onto the puncture site, suck the whole blood directly and place 50 µL into the specimen well (S) of the test device, then add exactly 50 µL of buffer into the specimen well and start the timer. See illustration below.

C.For Fingerpick Whole Blood Specimens (qualitative):

To use a capillary dropper: Hold the dropper vertically onto the puncture site, and transfer 5 drops of whole blood (approximately 50 µL) into the specimen well (S) of the test device, then add 1 drop of buffer (approximately 45-50 µL) and start the timer. See illustration below.

3.Wait for the colored line(s) to appear. Read results at 10 minutes. Do not interpret the result after 15 minutes.
INTERPRETATION OF RESULTS

• Positive (+): Only C line appears, or T line is equal to C line or weaker than C line. It indicates that there are SARS-CoV2 neutralizing antibodies in the specimen.
• Negative (-): Both the T line and C line appear, when the intensity of T line is stronger than C line. It indicates that there is no SARS-CoV2 neutralizing antibodies in the specimen, or else the titer of SARS-CoV2 neutralizing antibodies are of very low level.
• Invalid: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test. If the problem persists, discontinue using the test kit immediately and contact your local distributor.

Sense of quantitative and qualitative result.

	Qualitative (compare the intensity of T line with the C line)	Reference value (Quantitative)
Negative	The line T is darker than that of line C	Nab < 100ng/ml
Low titer (grey zone)	The line T is equal to or slightly lighter than line C	100ng/ml ≤ Nab ≤ 300ng/ml
Middle titer	The line T is apparently lighter than line C	300ng/ml < Nab ≤2000ng/ml
High titer	The line T is very light or colorless	Nab >= 2000ng/ml

PERFORMANCE CHARACTERIST
1. Relative Sensitivity, Specificity and Accuracy
The SARS-CoV2 Neutralizing Antibody Rapid Test has been evaluated with specimens obtained from a population of positive and negative specimen. Results were confirmed by a commercial SARS-CoV2 Neutralization Antibody Detection Kit (ELISA kit, cutoff 30% signal inhibition).

Method		A commercial SARS-CoV2 Neutralization Antibody Detection Kit (ELISA kit)		Total Results
SARS-CoV2 Neutralizing Antibody Rapid Test (COVID19 Ab)	Results	Positive	Negative
	Positive	32	0	32
	Negative	1	167	168
Total Result		33	167	200

Relative Sensitivity: 96.97%(95%CI:83.35%~99.99%)  
Relative Specificity: 100.00%(95%CI:97.29%~100.00%)
Accuracy: 99.50%(95%CI:96.94%~99.99%)

2.Detection of Limit

Cutoff:200ng/ml
Detection range:100~8000ng/ml

3.Calibration Curves

1. 4.Cross-Reactivity

Cross-reactivity of the SARS-CoV2 Neutralizing Antibody Rapid Test was evaluated using serum or plasma specimen which contain antibodies to the pathogens listed below. No false positive or false negative was found with the following.

COVID19 N-protein IgG/IgM	HCoV-HKU1 IgG
HCoV-NL63 IgG	Influenza A IgM/IgG
HCoV-229E IgG	Influenza B IgM/IgG

1. 5.Interfering Substances

The following substances were spiked into the unvaccinated healthy people's negative serum specimen, to observe the false positive effects. None false positive was observed in the studies.
α-IFN                                              0.2mg/mL
β-IFN                                              0.2mg/mL
Histamine                                       5μg/mL
Human anti-mouse antibody1mg/mL
Human IgG                                    5mg/mL
Human IgM                                    0.5mg/mL
Human serum albumin 10mg/mL
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