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Torch Rapid Test Combo Whole Blood/Serum/Plasma Sample Rapid Diagnostic Test Kit

Basic Information
Place of Origin: China
Brand Name: Dewei
Certification: ISO
Model Number: TOR-DW102
Minimum Order Quantity: 3000 units
Price: Negotiable
Packaging Details: 25test/box
Delivery Time: in 20 days
Payment Terms: L/C, T/T, Western Union
Supply Ability: 500,000pcs/day
Detail Information
Sample: Whole Blood/Serum/Plasma Type: Cassette
Certificate: ISO, CE Origin: China
Shelf Life: 24 Months Usage: Professional Use
Highlight:

Whole Blood Rapid Test Kit

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Plasma Rapid Test Kit

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Serum Rapid Test Kit


Product Description

Torch Rapid Test Combo Whole Blood/Serum/Plasma Sample Rapid Diagnostic Test Kit

For professional use only.
For in vitro diagnostic use only.
 

【INTENDED USE】

Torch rapid test combo is a rapid qualitative lateral flow test designed for the qualitative detection of the IgG antibodies to thefollowing viruses: Toxoplasma gondii (Toxoplasmosis)(TOXO), Cytomegalovirus(CMV), Rubella Virus (RV), Herpes Simplex Virus Type 1 (HSV-1) and Herpes Simplex Virus Type 2 (HSV-2) in human whole blood, serum or plasma.

 

 

 

【INTRODUCTION】
The acronym TORCH was introduced in 1971 by Nahmias et al. to highlight a group of viral diseases which affect thefoetus and newborn, namely Toxoplasma gondi, rubella virus, cytomegalovirus (CMV), and herpes simplex virus (HSV)These diseases often lead to a similar clinical picture which include one or more of the following clinical signs: ow birthweight, prematurity, purpura, jaundice, anemia , microcephaly, hydrocephaly, cerebral calcification, chorioretinitis, cataracts.microphthalmia and pneumonitis. TORCH screening is now widely requested by clinicians investigating infants andpregnant women for congenital, perinatal and neonatal infections.
Toxoplasmosis (TOXO) is a systemic disease,caused by the protozoa Toxoplasma gondi. Infection inImmuno-compromised patients and in the developing fetus can lead to serious consequences. Opportunistic toxoplasmosisinfection or reactivation of a subclimical infection in Immuno-compromised patients may cause encephalitis, pneumonitisand myocarditis. In the congenitally infected fetus the infection may spread to the central nervous system. Abortion andstillbirth may occur when infection takes place during the first trimester of pregnancy, and irreversible neurological damagesin case of infection during the second or third trimester.
Cytomegalovirus(CMV) infection is mainly asymptomatic. But primary infection during early pregnancy may also leadto congenital abnormalities in the fetus, and infection in immuno-deficient patients is the most common infectious cause ofmortality. Screening for IgG antibodies to CMV is useful to establish previous exposure to CMV.Determination of the CMVIgG antibody level at weekly or biweekly intervals also enables diagnosis of acute infection through the demonstration of a significant rise in antibody titer.
Rubella(also called German measles or 3-day measles) is a disease caused by the rubella virus. Although rubella canstrike people of all ages, it poses the greatest danger to unborn babies.Congenital rubella syndrome(CRS) occurs when therubella vinus attacks a developing fetus. Up to 85% of infants infected during the first trimester will be bom with birthdefects,including deafness, blindness, heart defects, and mental retardation. Miscarriages are also common. Growthretardation and diabetes mellitus have also been associated with late complications of congenital nubella. Screening for IgG antibodies to rubella vinus is a useful tool for diagnosis of the disease, and for determination of the immune status. Serialdetermination of the rubella IgG antibody level in the infant, therefore, will assist in the differentiation between congenitalrubella (plateau level) or neonatal rubella (increase in titer).
Herpes Simplex Virus Type 1 (HSV-1) and Herpes Simplex Virus Type 2 (HSV-2) are similar.Both types can recur andspread even when no symptoms are present. HSV-1 is the cause of most orofacial herpes and HSV encephalitis; HSV-2 is theprimary cause of initial and recurrent genital herpes and neonatal HSV.The presence of HSV-1 IgG antibody or HSV-2antibody in serum is an indication of previous exposure. A significant increase in HSV-1 or HSV-2 IgG antibody is anindication of reactivation of the respective Herpes Simplex Virus current or recent infection.

 

 

【PRINCIPLE】
The TORCH IgG/IgM Antibodies Combo Test is a rapid chromatographic immunoassay for the qualitative detection of antibodies (IgG and IgM) to Toxo, Rubella, CMV, and HSV1/2 in Serum or Plasma. Each test consists of: 1) a burgundy colored conjugate pad containing TORCH recombinant envelope antigens conjugated with Colloid gold (TORCH conjugates) and rabbit IgG-gold conjugates,2) a nitrocellulose membrane strip containing two test bands (IgM and IgG bands) and a control band (C band). The IgM band is pre-coated with the antibody for the detection of IgM anti-TORCH, IgG band is coated with antibody for the detection of IgG anti-TORCH, and the C band is pre-coated with goat anti rabbit IgG. When an adequate volume of test specimen is dispensed into the sample well of the test cassette, the specimen migrates by capillary action across the cassette. IgG anti-TORCH, if present in the specimen, will bind to the TORCH conjugates. The immunocomplex is then captured by the reagent pre-coated on the IgG band, forming a burgundy colored IgG band, indicating a TORCH IgG positive test result and suggesting a recent or repeat infection. IgM anti-TORCH if present in the specimen will bind to the TORCH conjugates. The immunocomplex is then captured by the reagent coated on the IgM band, forming a burgundy colored IgM band, indicating a TORCH IgM positive test result and suggesting a fresh infection. Absence of any T bands (IgM and IgG) suggests a negative result. The test contains an internal control (C band) which should exhibit a burgundy colored band of the immunocomplex of goat anti rabbit IgG/rabbit IgG-gold conjugate regardless of the color development on any of the T bands. Otherwise, the test result is invalid and the specimen must be retested with another test cassette.

 

 

 

【CONTENTS
• Rapid Test.
• Buffer
• Disposable pipettes
• Instruction for use.
 
 
 
PRECAUTIONS
• Do not use after expiration date indicated on the package. Do not use the test if its foil pouch is damaged. Do not reuse tests.
• This kit contains products of animal origin. Certified knowledge of the origin and/or sanitary state of the animals does not totally guarantee the absence of transmissible pathogenic agents. It is therefore, recommended that these products be treated as potentially infectious, and handled observing the usual safety precautions (do not ingest or inhale).
• Avoid cross-contamination of specimens by using a new specimen collection container for each specimen obtained.
• Read the entire procedure carefully prior to performing any tests.
• Do not eat, drink or smoke in the area where the specimens and kits are handled. Handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout the procedure and follow the standard procedures for proper disposal of specimens. Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed.
• Buffered Saline contains sodium azide which may react with lead or copper plumbing to form potentially explosive metal azides. When disposing of buffered saline or extracted samples, always flush with copious quantities of water to prevent azide build up.
• Do not interchange or mix reagents from different lots.
• Humidity and temperature can adversely affect results.
• The used testing materials should be discarded in accordance with local, state and/or federal regulations.
 
 

 

【STORAGE AND STABILITY】
• The kit should be stored at 2-30°C until the expiry date printed on the sealed pouch.
• The test must remain in the sealed pouch until use.
• Keep away from direct sunlight, moisture and heat.
Do not freeze.
• Care should be taken to protect the components of the kit from contamination. Do not use if there is evidence of microbial contamination or precipitation. Biological contamination of dispensing equipment, containers or reagents can lead to false results.
 
 

 

【SAMPLE COLLECTION】
• The Torch Test is intended for use with human whole blood, serum or plasma specimens only.
• Only clear, non-hemolyzed specimens are recommended for use with this test. Serum or plasma should be separated as soon as possible to avoid hemolysis.
• Perform testing immediately after specimen collection. Do not leave specimens at room temperature for prolonged periods. Serum and plasma specimens may be stored at 2-8°C for up to 3 days. For long term storage, specimens should be kept below -20°C.
• Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed and mixed well prior to testing. Avoid repeated freezing and thawing of specimens.
• If specimens are to be shipped, pack them in compliance with all applicable regulations for transportation of etiological agents.
• Icteric, lipemic, hemolysed, heat treated and contaminated sera may cause erroneous results.
 

 

 

【OPERATION
Bring tests, specimens, buffer and/or controls to room temperature (15- 30°C) before use.
1. Remove the test from its sealed pouch, and place it on a clean, level surface. Label the cassette with patient or control identification. For best results, the assay should be performed within one hour.
Using the provided disposable pipette, transfer 1 drop of whole blood, serum or plasma specimen to each specimen well (S) of the cassette, then add 1 drop of buffer and start the timer.
Avoid trapping air bubbles in the specimen well (S), and do not add any solution to the result window.
As the test begins to work, color will migrate across the membrane.
2. Wait for the colored band(s) to appear. The result should be read within 10-15 minutes.

 

 

 
【INTERPRETATION OF RESULTS】
There are five result windows altogether, which indicates the testing result of TOXO, RV, CMV, HSV-I and HSV-II respectively. After applying samples, either one line or two lines will appear in each result window. The interpretation of the result is as follow:
Positive (+) :
IgG Positive: Both IgG test region (IgG) and control region appear color line.
IgM Positive: Both IgM test region (IgM) and control region appear color line.
IgG/IgM Positive: Both test region (IgG and IgM) and control region appear color line.
Negative (-) :
Only one color line appears on the control region (C).
Invalid:
No visible line at all, or there is a visible line only in the test region and not in the control region. Repeat with a new test kit.
 
 
 

For further operation or performance details, please refer to final instruction manual.

 

 

 

 

Contact Details
Bonnie He

Phone Number : +8613030247038

WhatsApp : +8615267039708