CLIABook III

Improve antenatal care with ToRCH tests

Follow Mindray on Social Media

Join LabClub, a global online community

for lab professionals.
www.mindray.com
APP Store
labclub.mindray.com P/N: ENG-CLIABook III-210285X16P-20221021
©2022 Shenzhen Mindray Bio-Medical Electronics Co.,Ltd. All rights reserved.
Content
ToRCH Overview and Importance of ToRCH Tests 01

Toxoplasmosis and Pregnancy 03

Clinical Application of CMV Detection in Various Departments 05

Rubella and Pregnancy 07

Mindray Launches High-Sensitivity and High-Specificity ToRCH Panel 09

Mindray CLIA Test Menu 12

References 12
 Chapter 1

The exact symptoms vary depending on the specific In general, ToRCH infections are responsible for 2% to 3% of
underlying infection, but TORCH infections can share some all congenital disorders, or disorders present at birth. These
non-specific signs and symptoms[2]. infections can cause a variety of complications, including

ToRCH Overview and Jaundice

preterm birth, delayed development of the fetus, physical
malformations, and miscarriages[3].
Cataract
Importance of ToRCH Tests CMV

Rubella

Parvovirus

T. pallidum

VZV
Toxoplasma
HIV

Hepatomegaly * Abbreviation:
T. pallidum: Treponema pallidum
VZV: Varicella zoster virus
CMV: Cytomegalovirus
HIV: Human immunodeficiency virus
Purpura
The ToRCH syndrome is an infection of a developing fetus or newborn that can occur in utero, during delivery, or after birth,
which is caused by any group of infectious agents[1].

Other diseases, Due to the severe consequences of ToRCH infections, it is important to take ToRCH serological tests from pre-pregnancy to
Toxoplasmosis including HIV after birth to protect the fetus against ToRCH infections.
syphilis and hepatitis

ToRCH Pre-pregnancy

Detection for ToRCH infection should be

Early stage Neonate

Suspected neonates must be tested by PCR

available to all the women who are pregnant or or serologicaltestes and should take physical
planning a pregnancy. A non-pregnantwoman examination to check if there are clinical
Herpes simplex virus Rubella who has been diagnosed with an acute ToRCH
infection should be counsel to before
manifestationsofinfection.
(HSV) (German measles)
attemptingto become pregnant.

A majority of ToRCH tests are routinely conducted in early pregnancy.

Cytomegalovirus (CMV)
01 02
 Chapter 2

Besides pregnant women and infants, AIDS patients and organ The most common manifestations of congenital toxoplasmosis
transplant recipients are also vulnerable to Toxoplasma gondii. include chorioretinitis, hydrocephalus, and intracranial
calcifications. Some babies with congenital toxoplasmosis may
Population at risk exhibit multiple purple-blue marks in the skin.

Toxoplasmosis
Organ transplant AIDS
recipients patients

and Pregnancy
Chorioretinitis Hydrocephalus

Congenital
toxoplasmosis

Pregnant
Infants Intracranial Purple-blue
women
calcifications marks
Toxoplasma gondii is a protozoan parasite that infects most species of warm-blooded animals, including humans, and causes
toxoplasmosis.

Toxoplasmosis usually occurs after eating undercooked contaminated meat, exposure to infected cat feces, or mother-to-child
According to CDC (Centers for Disease Control and Prevention), the detection of Toxoplasma-specific antibodies is a primary
transmission during pregnancy[4].
diagnostic method to determine infection with Toxoplasma. Newborn infants suspected of congenital toxoplasmosis should be tested
by both IgM- and IgA-capture EIA. Also, this detection is recommended for immunocompromised patients, such as AIDS patients[5].

Acute infection Chronic infection

Ab levels
lgG

lgM

Mother-to-child transmission Contact with cat feces Consumption of undercooked meat

0 1 2 3 4 5 6 7 8 9 10 11 12 0
Time(months)
Serological changes of Toxoplasma infection[6]

03 04
 Chapter 3

Primary CMV infection in pregnant women will cause about

30% intrauterine infection and 60% to 80% of their infected
Value of CMV Tests in Infection Department
neonates will develop sequelae. In contrast, pregnant women
In the infection department, patients are often seen to
with secondary CMV infection have only a 0.2% -2% risk of
have an unexplained fever. All of them need to take
causing intrauterine infection. This is why it is important to
Clinical Application of identify primary CMV infection as early as possible.
CMV tests to rule out infection factors. Both IgG/IgM
and DNA need to be detected due to the urgency,

CMV Detection in
According to CDC, serological tests that detect CMV antibodies especially for HIV patients.
(IgM and IgG) are widely available in commercial laboratories.
Usually, every HIV patient should be tested for CMV

Various Departments
IgM positive results in combination with low IgG avidity results
every three months, regardless of whether they are
are considered reliable evidence for primary infection[7].
outpatients or inpatients.
lgM
lgG

Antibody titres
Acute Past
Infection Infection

Time
lgG positive lgG positive lgG positive
lgM positive lgM negative/positive IgM positive
Low Avidity High Avidity High Avidity
Serological changes of CMV infection[8]
Cytomegalovirus (CMV) is a common virus that is usually A pregnant woman can pass CMV to her fetus following
harmless and transmitted through sexual contact or contact infection by CMV for the first time, reinfection with a
with blood and other body fluids of an infected person, or different CMV strain, or reactivation of a previous infection CMV testing can not only be used in Obstetrics and
from transplanted organs. The virus can also spread from an during pregnancy. Neonatology, it can also be applied in some special Value of CMV Tests in Transplantation Department
infected mother to the growing fetus through the placenta. departments since primary CMV infection is generally Before operation, both the donor and recipient need
CMV causes infection & asymptomatic in healthy adults but can cause severe and to take CMV serological tests to improve the
defects in the fetus even fatal diseases in immunocompromised individuals prognosis after transplantation.
and transplant recipients. Since the numbers of both HIV
After operation, the recipient needs to take CMV
and transplantation patients are increasing, there has been
Primary infection serological tests periodically since CMV infection can
Saliva a growing demand for CMV tests in infection and
01 Infected by CMV
for the first time transplantation departments. Respiratory and
be troublesome to transplant patients.

Urine and Sexual dermatology departments may also prescribe CMV tests
feces contact for patients with allergic symptoms.

CMV Infection Dermatology

Primary infection
Department Department
Another new
02 strain of CMV
Blood Transplanted
transfusions organs CMV
Detection
Secondary infection
Reactivation of
03 an old infection
Respiratory droplets Vertical transmission Transplantation Respiratory
(coughing or sneezing) (trans-placental or breast milk) Department Department

05 06
 Chapter 4

Neonates born with congenital rubella syndrome usually have a tetrad of symptoms: hearing loss or deafness, eye abnormalities,
dermal extramedullary hematopoiesis and congenital heart disease.

Eye Sensorineural
Abnormalities Hearing Loss
Rubella and
Pregnancy

Dermal
Congenital Extramedullary
Heart Disease Hematopoiesis

Rubella, also known as “German Measles‘’, is caused by the rubella virus and it can be transmitted to a pregnant woman via Congenital Rubella Syndrome (CRS), which can occur when a woman is infected with rubella during pregnancy, can lead to a variety
respiratory droplets. Most children from 12 to 15 months of age get the MMR vaccine against measles, mumps, and rubella. of possible birth defects. According to CDC, CRS cases can be diagnosed in newborns and infants through rubella IgM detection.
Suspected cases should be tested as close to birth as possible and again at 1 month of age if the initial IgM test result is negative[9].
Rubella virus can be transmitted to a pregnant woman via respiratory droplets. Another route for Rubella to spread is from a
pregnant woman to her unborn child, through the placenta. This causes congenital rubella syndrome in the fetus.
Virus detectable in nasopharynx
Virus detectable in blood

Rash
Rubella infection routes

lgG

Relative levels
lgM

Transmitted via respiratory droplets Pregnant female Placenta Unborn child

-2 -1 0 1 2 3 4 5 6 7 8 9 10 11
Weeks after onset of rash

Infection Rash onset

Serological changes of Rubella infection[10]

07 08
 Chapter 5

Advanced formulas and reaction models units and the latest standardized traceability. Toxo IgG
contains specific IgG and features DT test standardization.

Mindray Launches High-Sensitivity At the formulation level, Mindray R&D experts investigated
the interference mechanism and classified the
CMV IgG adopts the first international standard and features
long-term stability. RV IgG comes with a cutoff value of 10

and High-Specificity ToRCH Panel interference into four different types to help enhance the
anti-interference capacity.
IU/mL as recommended by WHO.

Analyte Capture Ag/Ab

WHO International Standard
Interfering/cross
Labeled detector
Anti Rubella Immunoglobulin,
reacting system
RV IgG Human NIBSC code: RUBI-1-94
Heterophilic Blocker
antibody WHO recommendation:
Cutoff=10 IU/ml

WHO International Standard

Anti-Toxoplasma IgG,
Human NIBSC code: 01/600
Toxo lgG
Containing specific lgG
DT test standardisation
Better interoperability
Hundreds of commercial and uniquely designed blockers
were studied and applied to minimize each type of
Mindray has recently launched the ToRCH Panel, a result of requirements. To improve the sensitivity and specificity, interference. For instance, Mindray R&D team designed a
our ongoing commitment to innovation. With this panel, we Mindray experts spent a considerable amount of time capture method for the IgM assay to minimize the WHO 1st International Standard
provide high-quality assays to meet different clinical needs. thoroughly studying the parameters using a DOE approach. interference of IgG and RF (Rheumatoid Factor). for detection of IgG antibodies to
With a robust design, the boundary of each parameter was Cytomegalovirus (anti-CMV IgG)
determined to ensure the reproducibility of the process. Code number 136616/17
High sensitivity and specificity
CMV IgG The first international standard
Magnetic beads ALP coupling long-term stability
coating process process Better interoperability
To achieve high sensitivity and specificity, Mindray has
Magnetic beads ALP design
been working consistently to improve the raw materials,
processes, formulas, and reaction models. High quality Raw material characteristic Raw material characteristic
materials are fundamental to ensure high sensitivity and Particle size ALP source
Chemical group Coupling systems
specificity of CLIA assays. To cater to different projects and
process requirements, Mindray invested a lot of resources Seroconversion sensitivity[12]
in the design and development of immunodominant
Coating parameters Labeling parameters lgM model lgG model
proteins and immunodominant epitopes. Thanks to the improved raw materials, processes, formulas,
More than 20 parameters More than 30 parameters reaction models, and standardized traceability, Mindray
DOE (Design of DOE design
Experiment) design Purification ToRCH reagents deliver excellent seroconversion sensitivity.
Efficient processes
Mindray ToRCH has a good detection rate for both samples
Traceability of IgG for reliable medical that are positive in multiple systems and true positive
Mature, stable and innovative technology is another Reliability
determination samples such as seroconversion panels. The combined
guarantee of satisfactory performance. For the coating and examination by Mindray ToRCH IgG and IgM can accurately
Optimal median value
labeling processes, Mindray R&D team selected the Excellent tolerance
The above three quantitative kits of Mindray ToRCH panel reveal previous infections and promptly detect ToRCH
particles and ALPs that can best meet the assay are fabricated with materials with international standard infections that failed to be ruled out previously.
09 10
 Chapter 5

Toxo IgG
ASI Toxoplasma Gondi Seroconversion Panel
Toxo IgM
ASI Toxoplasma Gondi Seroconversion Panel
RV IgG
SCP-RUB-002
Mindray CLIA Test Menu
Mindray’s CLIA test penal so far has 79 high-performance reagents which are developed to work with Mindray's CL series
Positive
lgG Conc.

lgG Conc.
conversion on chemiluminescence immunoassay analyzers. By combining the strength of HyTest, a global leading provider of antibodies and

COI
Positive Positive
Day 15
conversion on conversion on antigens acquired by Mindray, our test menu will reach more than 100 assays in the near future. Mindray uses liquid,
Day 28 Day 19
ready-to-use reagents which come in two packages, 50 tests and 100 tests, to suit customers with different requirements.
0 20 40 60 80 100 120 140 0 20 40 60 80 100 120 140 0 5 10 15 20 25 30 35 40 45
Days Days Days

RV IgM CMV IgG CMV IgM

Thyroid Fertility Bone Metabolic ToRCH
SCP-RUB-002 SCP-CMV-007 SCP-CMV-007

lgG Conc. Positive

Positive conversion on Infectious Disease Tumor marker Cardiac Adrenal Function
COI

COI
Positive
conversion on Day 27
conversion on HIV Combo CEA CK-MB DHEA-S
Day 39 AFP Myoglobin Cortisol
Day 19 HBsAg
FT3 Anti-HBs Total β-HCG CA125 Intact PTH Troponin I Toxo IgG* ACTH
0 5 10 15 20 25 30 35 40 45 0 20 40 60 80 100 0 20 40 60 80 100 FT4 HBeAg FSH CA15-3 Calcitonin BNP Toxo IgM*
Days Days Days T3 Anti-HBe LH CA19-9 Vitamin D total hs-cTn I* Rubella IgG*
T4 Anti-HBc Prolactin Free PSA NT-proBNP* Rubella IgM*
*The X axis ‘Day’ stands for the days counted from the first day when the patient’s serum was collected, and doesn’t indicate any diagnosis or contact tracing information Total PSA
TSH Anti-HCV** Estradiol CMV IgG*
Anti-Tg Anti-TP (Syphilis) Estriol NSE CMV IgM*
Anti-TPO HAV IgM* TESTO CYFRA 21-1 HSV-1/2 IgG*
Tg PROG CA72-4 HSV-1/2 IgM*
rT3 AMH PG I HSV-1 IgG*
Excellent clinical performance Flexible blood collection and transportation TRAb* Free testosterone* PG II
SCCA
HSV-2 IgG*
17-OH PROG*
SHBG* HE4
ProGRP
CA50
To demonstrate the sensitivity and specificity of the Mindray ToRCH kits support diverse sample types with less CA242
PIVKA-II*
Mindray ToRCH kits, Mindray conducted tests in over five quality controls and sample volumes, which ensures great AFP-L3%*
Hp IgG*
clinical sites both in and outside China. ease and convenience during clinical detection. G-17*
By bringing the clinical benefits of ToRCH Panel into play S100*

Performance Items China sites[13] and addressing the key requirements for the reagents,
Diabetes Anemia Inflammation Liver Fibrosis
Mindray has solved the ToRCH detection challenges facing
Toxo lgG /
clinical laboratories and made Mindray ToRCH assays
COVID-19 Growth Hormone Hypertension DS’ Screening
Sensitivity RVIgG 97.63%-100.0%(total 2223) accessible in clinical application.
SARS-COV-2 IgG GH* Renin PAPP-A*
SARS-COV-2 IgM IGF-1* Aldosterone Free β-HCG*
CMV IgG 98.45%-99.77%(total 2772) Support diverse sample types SARS-COV-2S- Insulin Ferritin Procalcitonin Laminin
RBD IgG C-peptide Vitamin B12 IL-6* Hyaluronic Acid
SARS-COV-2 Folate sCD14-ST* PIIINP
Toxo lgG 97.59%-98.60%(total 2459) 3 types of serum collection tubes: no additive tube,
Neutralizing RBC Folate Collagen IV
Antibody
Pro-coagulation tube, gel and clot activator tube *: Under development
Specificity RV IgG 94.62%-99.00%(total 193) **: Non-CE
4 types of plasma collection tubes: EDTA, Sodium
Heparin, Lithium Heparin and Sodium Citrate
CMV IgG /

Toxo IgM 97.45%-98.42%(total 4224) References

Multiple quality controls [1] https://my.clevelandclinic.org/health/diseases/23322-torch-syndrome
Specificity RV IgM 97.37%-99.71%(total 3558) [2] https://my.clevelandclinic.org/health/diseases/23322-torch-syndrome
Only 3 control products are required for the whole [3] http://what-when-how.com/medical-microbiology-and-infection/congenital-and-perinatal-infections-systemic-infection/

CMV IgM 96.63%-98.47%(total 4011) panel: 1 negative control for all 6 assays, 1 positive [4] https://www.mayoclinic.org/diseases-conditions/ toxoplasmosis/symptoms-causes/syc-20356249
control for the 3 IgG assays, and 1 positive control for [5] https://www.cdc.gov/dpdx/toxoplasmosis/index.html
the 3 IgM assays. [6] Teimouri, A. , et al. "Role of Toxoplasma gondii IgG avidity testing in discriminating between acute and chronic toxoplasmosis in pregnancy." Journal of Clinical Microbiology (2020).
Although the positive rate varies among different [7] https://www.cdc.gov/cmv/clinical/lab-tests.html
countries and regions, Mindray ToRCH kits have exhibited [8] P Rice. "Cytomegalovirus (CMV) in pregnancy." (2008).

great specificity for Toxo IgG and ToRCH IgM and excellent Low sample volume [9] https://www.cdc.gov/rubella/lab/serology.html
[10] Emeritus Prof JE Banatvala FRCPath , DWG Brown FRCPath. "Rubella." The Lancet, Volume 363, Issue 9415, 3 April 2004, Pages 1127-1137
sensitivity for RV IgG and CMV IgG. In addition, given the Only 53 μL of sample volume is required for the 6 assays [11] Mindray ToRCH IFU
wide coverage of the clinical tests, there are no significant combined, which is friendly to newborns and infants. [12] Mindray internal evaluation
differences between the Chinese and international sites. [13] Mindray external evaluation

11 12