中和抗体-自测试

Jiangsu Medomics Medical Technology Co., Ltd., founded in October 2017, is located at Biotech and Pharmaceutical Valley of the National Jiangbei New Area, Nanjing, Jiangsu Province. It is an international high-tech enterprise driven by innovation in the area of medical devices R&D, production and sales. Medomics focuses on diagnosis of microorganisms, tumors and some rare diseases, mainly engaged in the research and development, production and sales of in vitro diagnostic reagents and automatic instruments.

VNT

Sample
Time of testing
Laboratory level
Operation

blood / serum / plasma
5 days
BSL-3
High requirement

Rapid Test

Sample
Time of testing
Laboratory level
Operation

blood / serum / plasma
15min
BSL-2
basic

VNT

Sample
Time of testing
Laboratory level
Operation

blood / serum / plasma
5 days
BSL-3
High requirement

Rapid Test

Sample
Time of testing
Laboratory level
Operation

blood / serum / plasma
15min
BSL-2
basic

COVID-19 Case Timeline

New method by Medomics

New method by Medomics

Clinical Evaluation Report And Certification

Clinical Evaluation Report And Certification

FOR IN VITRO DIAGNOSTIC USE ONLY.
FOR SELF-TESTING.
PLEASE READ INSTRUCTIONS CAREFULLY
BEFORE YOU PERFORM THE TEST.

FOR IN VITRO DIAGNOSTIC USE ONLY.

FOR IN VITRO DIAGNOSTIC USE ONLY.

KIT CONTENTS

KIT CONTENTS

Test Cassette
(individually in a foil
pouch with desiccant)

Alcohol Pads

Individual
Bufer Solution

Disposable
Lancet

Capillary Tube

Instructions For Use
(IFU)

Bio-Safety Bag

Preparation

Preparation

Wash and dry hands.

Carefully read IFU.

Check the expiry

date on the foil pouch.

Anterior Nasal Secretion Test Procedure

Anterior Nasal Secretion Test Procedure

Massage the fnger to be tested.

Wipe fnger with alcohol pad.

Rotate the protective cap out，Remove it from the lancet.

Then place end of lancet on the test site and push the lancet down of the fnger.

Hold the capillary tube and dip it into the fngertip blood sample, keep the capillary tube horizontal, do not cover the air hole. The capillary tube would absorb blood sample until the sample flled the whole tube to the scale line.

Cover the air hole with fngers,squeeze the gasbag to inject the blood into thesample well on test cassette.

Open the foil pouch, then lay the
test cassette on a clean fat surface

Twist to open the Individual bufer solution and add 4 drops of diluent into sample well.

Rotate the protective cap out，Remove it from the lancet.

Result observed after
20mins is invalid

Massage the fnger to be tested.

Wipe fnger with alcohol pad.

Rotate the protective cap out，Remove it from the lancet.

Then place end of lancet on the test site and push the lancet down of the fnger.

Hold the capillary tube and dip it into the fngertip blood sample, keep the capillary tube horizontal, do not cover the air hole. The capillary tube would absorb blood sample until the sample flled the whole tube to the scale line.

Cover the air hole with fngers,squeeze the gasbag to inject the blood into thesample well on test cassette.

Open the foil pouch, then lay the
test cassette on a clean fat surface

Twist to open the Individual bufer solution and add 4 drops of diluent into sample well.

Rotate the protective cap out，Remove it from the lancet.

Result observed after
20mins is invalid

DISPLAY OF THE RESULT / EXPECTED VALUE

DISPLAY OF THE RESULT / EXPECTED VALUE

“C”：Quality Control Line “T”：Detection Line “S”：Sample Well

“C”：Quality Control Line

• Positive result: If both thequality control C line and the detection T line appear, it means that the SARS-CoV-2 neutralizing antibody has been detected, and the result is positive for neutraliz-ing antibody.

“T”：Detection Line

• Negative result: If only the quality control C line appears and the detec-tion T line does not show color, it means that the SARS-CoV-2 neutraliz-ing antibody has not been detected and the result is negative.

“S”：Sample Well

• Invalid result: If the quality control Cline cannot be observed, the result is invalid regardless of whether there is a detection line display, and the test should be repeated.

• Positive result: If both thequality control C line and the detection T line appear, it means that the SARS-CoV-2 neutralizing antibody has been detected, and the result is positive for neutraliz-ing antibody.

• Negative result: If only the quality control C line appears and the detec-tion T line does not show color, it means that the SARS-CoV-2 neutraliz-ing antibody has not been detected and the result is negative.

• Invalid result: If the quality control Cline cannot be observed, the result is invalid regardless of whether there is a detection line display, and the test should be repeated.

EN

ES

2

SARS-COV-2 Neutralizing antibody Test Kit(LFIA)

SARS-CoV-2 & Influenza A/B Antigen Combo Rapid Test Kit (LFIA)

SARS-CoV-2 Antigen Test Kit (LFIA)