The Chagas Ab Combo Rapid Test is a lateral flow chromatographic
immunoassay for the qualitative detection of IgG anti-Trypanosoma cruzi (T. cruzi) in human serum, plasma or whole blood. It is intended to be used
as a screening test and as an aid in the diagnosis of infection
with T. cruzi. Any reactive specimen with the Chagas Ab Combo Rapid Test must be
confirmed with alternative testing method(s) and clinical findings.
Product details
Description
Delivery
Within 48 hours
Packaging Specifications
25 tests/box
Country Of Origin
China
Manufacturer
24months
Preservation method
2℃-30℃
Specimen
urine
Assification
class1
Type
Reply Test
REAGENTS AND MATERIALS PROVIDED
1.Each kit contains 30 test devices, each sealed in a foil pouch
with three items inside:
a. One cassette device.
b. One plastic dropper.
c. One desiccant.
2.Sample diluent (1 bottle, 5 mL)
3.One package insert (instruction for use).
ASSAY PROCEDURE
Step 1: Bring the specimen and test components to room temperature
if refrigerated or frozen. Mix the specimen well prior to assay
once thawed.
Step 2: When ready to test, open the pouch at the notch and remove
device. Place the test device on a clean, flat surface.
Step 3: Be sure to label the device with specimen’s ID number.
Step 4: For whole blood test
- Dispense 1 drop (about 40-50 µL) of the whole blood specimen into
the sample well
- Then add 1 drop (about 35 -50 µL) of Sample Diluent immediately
Storage
Store as packaged in the sealed pouch at 4-30°C, avoid hot and
sunshine, dry place, valid for 24 months.
DO NOT FREEZE. Some protective measures should be taken in hot
summer and cold winter to avoid high temperature or freeze-thaw.
Biovantion Inc is independent from international department of
Bioneovan Co., Ltd., which established in 2 0 0 5, is an in vitro
diagnostic reagents manufacturer engaged in the research,
development, production, and focus on clinical testing for
infectious diseases, such as Hepatitis virus, Noro virus, Parvo
virus test kits, our products include rapid test cassette and Elisa
kits.
All our products have been registered in National Medical Products
Administration of China, in year 2020 we get Certificate of ISO
13485:2016 – QUALITY MANAGEMENT SYSTEMS FOR MEDICAL DEVICES from
SGS. More importantly, we have awarded the registration certificate
from National Medical Products Administration for Diagnostic Kit
for IgM Antibody to COVID-19 and IgG antibody to COVID-19 during
the outbreak in China, and also we developed COVID-19 Antigen test
; Neutralizing Antibody Test, these products selling well all
overthe world
