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Diagnostic Kit

Specimens

- Respiratory Specimen
(Sputum, Nasopharyngeal swab, Oropharyngeal swab)

Analytes - COVID-19

Compatible instruments

- Applied Biosystems 7500/7500FAST
- CFX96 (Bio-Rad)

Store at -20℃ or below.
96 test/Kit

Made in Korea

COVID-19 RT-PCR KIT

HS Code 3822.00-2019

MOQ 500 kits

96tests/kit, 160kits/carton (15,360tests/carton)
Payment Term : Advanced Payment (according to volume, may be discussed)
Shipment Term : Ex-Works, Korea

SARS-like coronavirus (SARS-CoV-2) Real-Time RT-PCR Kit

COVID-19 Real-Time RT-PCR Kit is the One-Step Reverse Transcription Real-Time PCR Kit designed to detect Novel Corona virus (COVID-19) qualitatively through Reverse Transcription reaction and Real-Time Polymerase Chain Reaction.

Features

* About 120 minutes detection for COIVD-19 in a single tube
* Reverse Transcription reaction and Real-Time Polymerase Chain Reaction
* Easy-to-use(One-Tube) and interpretation
* Reliable result by Internal / Positive / Negative Control
* CE-IVD

Working Process

1

2

3

Read-time PCR
COVID-19 Plus
RT-PCR Kit
Cat NO. IFMR-45

Amplification

4

Sugentech-SGTi-flex-COVID-19-lgM&lgG

SGTi-flex COVID-19 IgM / IgG

Sugentech

WHY must IgM & IgG test

  • COVID-19, speedy and sustainable community spread even without identifying exactly who and how to spread.
  • COVID-19, onset of disease without or with very mere symptom but still highly infective and this can be extended up to 1 month.
  • So, COVID-19 the RT-PCR searching for genetic material of virus from patient’s nasal of oral swab could show very limited sensitivity (even less than 30% for the previous corona case*) and huge drawback.
Kinetics-of-Seroconversion-for-lgM-and-lgG

HOW great IgM & IgG test

  • Every COVID-19 patients without exception 100% generates very specific antibody against corona virus, SARS-CoV-2.
  • COVID-19 virus specific IgM the first antibody, detected before 1 week of onset and IgG follows. If both analyzed, strong and sustainable diagnosis capability can be secured.

Strength of Sugentech SGTi-flex COVID-19 IgM/IgG

Outstanding performance

TOTAL RT-PCR
Pos Neg
SGTi-flex
COVID-19
IgM/IgG
Pos 47 4
Neg 3 96
Total  50 100
Accuracy Kappa
95.3% 0.90
 
Total Enroll 150 Sensitivity Specificity
94% 96%

Reference

  • Kinetics of Severe Acute Respiratory Syndrome (SARS)Coronavirus-Specific Antibodies in 271 Laboratory-Confirmed Cases of SARSCLINICAL AND DIAGNOSTIC LABORATORY IMMUNOLOGY, July 2004
  • Clinical progression and viral load in a community outbreak of coronavirus-associated SARS pneumonia: a prospective study. THE LANCET • Vol 361 • May 24, 2003
  • Antibody responses in COVID-19 patients, preprint in the progress of review https://doi.org/10.1101/2020.03.02.20030189
  • WHO guideline in the MERS
  • https://www.cdc.gov/coronavirus/2019-ncov/about/testing.html

Good Usability

Test procedure for COVID-19 IgM/IgG

1. Collecting of Sample

For test, 10 µl of whole blood, plasma or serum is used.
Collect the blood sample obtained by venipuncture into blood collection tube
or use fingertip blood.

2. Adding of Sample

Add the collected serum/plasma/whole blood to the sample well of the test
cassette.

3. Dropping of Sample buffer

Add 3 drops (~90μl) of sample into the sample well of the test cassette.

4. Reading Test result

Read test result at 10~15 minutes.

reading-test-result

Read after 10 mins.

Do not read after 30 mins.

Interpretation of Test Result

IgM Positive

IgG Positive

IgM/ IgG Positive

Negative

Invalid & Retest required

  1. The test is for qualitative detection of anti-COVID-19 antibody in human whole blood, serum or plasma and does not indicate the quantity of the antibodies.
  2. The test is for in vitro diagnostic use only.
  3. As in case of all diagnostic tests, a definitive clinical diagnosis should not be based on the result of a single but should rather be made after test all the clinical findings have been evaluated.

COVID-19 Easy Test HAV IgG/IgM

HS Code 3822.00-2019

Clinical Laboratory Application

(Diagnostic Kit)

One step kit for the qualitative and differential detection of IgG and IgM antibodies to 2019 Novel Corona virus in human whole blood, serum or plasma.

COVID-19 IgG/IgM Rapid Test Kit (Whole Blood/Serum/Plasma) is a solid phase immunochromatographic assay for the rapid, qualitative and differential detection of IgG and IgM antibodies to 2019 Novel Coronavirusi in human whole blood, serum or plasma.

This test provides only a preliminary test result. Therefore, any reactive specimen with the COVID-19 IgG/IgM Rapid Test kit (Whole Blood/Se-rum/Plasma) must be confirmed with alternative testing method(s) and clinical findings.

Performance characteristics

Product Name Sensitivity Specificity Detection limit
Easy Test HAV IgG/IgM IgG 85.1%
IgM 100%
IgG 93.1%
IgM 98.3%
IgG 4.26 s/CO
IgM 0.94 s/CO

Order infomation

Cat No. Description Specimen Type Package Shelf life
AM2525-K Asan Easy Test HAV IgG/IgM S/P Device 1Tx25/Kit 24M

Performance characteristics

Add 10㎕ of specimen

2drops of assay solution

15min

Reading

igg-igm-positive
IgG Positive
IgM Positive
igg-positive-igm-negative
IgG Positive
IgM Negative
igg-nagative-igm-positive
IgG Negative
IgM Positive
negative
Negative