Maternal and (Neonatal) Child Health

Antenatal care

Solutions for the diagnostic assessment according to WHO recommendations on antenatal care (WHO 2016)

HIV and syphilis: In high-prevalence settings, provider-initiated testing and counselling (PITC) for HIV should be considered a routine component of the package of care for pregnant women in all antenatal care settings. In low-prevalence settings, PITC can be considered for pregnant women in antenatal care settings as a key component of the effort to eliminate mother-to-child transmission of HIV, and to integrate HIV testing with syphilis, viral or other key tests, as relevant to the setting, and to strengthen the underlying maternal and child health systems.

Tuberculosis (TB): In settings where the TB prevalence in the general population is 100/100 000 or higher, systematic screening for active TB should be considered for pregnant women as part of antenatal care.

The listed items are CE-marked and comply with the strict requirements of the European IVD directive. Exceptions are clearly flagged.

Anemia

Full blood count testing is the recommended method for diagnosing anemia in pregnancy. In settings where full blood count testing is not available, on-site hemoglobin testing with a hemoglobinometer is recommended over the use of the hemoglobin color scale.

TypeDescriptionProduct name / item
Detection and Screening 
  • With cyanid-free recognized Hb reference method (Alkaline Hematin Detergent)
  • In remote areas, at the point-of-care (POC) or in the laboratory
HumaMeter HbPlus
Blood count testingAssessment of full 3-part CBC (complete blood count) even in remote areas or regions with minimal infrastructure3-part diff systems HumaCount 30TS and HumaCount 80TS in combination with solar charge and rechargeable battery HumaPower (accessories)
Blood count testingAssessment of full 5-part CBC (complete blood count) with capillary or venous blood HumaCount 5D

Blood grouping

TypeDescriptionProduct name / item
Immunohematology reagents
  • For ABO & Rh (Rhesus) factor testing
  • Suitable for patient and donor screening in blood banks

Gestational diabetes mellitus

Hyperglycemia first detected at any time during pregnancy should be classified as either gestational diabetes mellitus (GDM) or diabetes mellitus in pregnancy, according to WHO criteria.

TypeDescriptionProduct name / item
Assessment of glucose plasma levelsEven in remote areas or regions with minimal infrastructure
  • Glucose (GOD method or Hexokinase method)
  • Clinical chemistry analyzer HumaLyzer 4000 in combination with solar charge and rechargeable battery HumaPower (accessories)
Measurement and monitoring of blood glucose level In remote areas, at the point-of-care or in the laboratory

Hemostasis

Routine panel of screening parameters for diagnostic assessment of blood disorders related to coagulation and fibrinolysis. These assays are being performed to determine the risk of exceeded bleeding (like childbirth or surgery) as well as to determine levels after heart attack.

TypeDescriptionProduct name / item
Clot assessmentFor determination of prothrombin time (PT) by investigation of the extrinsic pathway
Clot assessmentFor determination of the activated partial thromboplastin time (aPTT) by investigation of the intrinsic pathwayHemostat aPTT-EL
Clot assessmentFor determination of the thrombin time (TT) for the basic screening profileHemostat Thrombin Time
Clot assessmentFor determination of fibrin clot formation (Clauss Method) to identify fibrinogen defectsHemostat Fibrinogen
Turbidimetric assayFor immunologic determination of D-dimer for exclusion of deep vein thrombosis of the leg or pulmonary embolismHemostat D-Dimer

HIV

TypeDescriptionProduct name / item
Rapid Screening Test For HIV-1 and HIV-2Hexagon HIV 
ELISAs 
  • For high sensitive antibody detection as well as state of the art 4th generation antigen and antibody detection.
  • For diagnostic and screening purposes.

Malnutrition

TypeDescriptionProduct name / item
Determination of nutritional factorsAssessment of a broad panel of nutrional factors even in remote areas or regions with minimal infrastructure
Blood count testing Assessment of full 3-part CBC (complete blood count) even in remote areas or regions with minimal infrastructure3-part diff systems HumaCount 30TS and HumaCount 80TS in combination with solar charge and rechargeable battery HumaPower (accessories)

Pneumonia

TypeDescriptionProduct name / item
Blood count testing Assessment of full 3-part CBC (complete blood count) even in remote areas or regions with minimal infrastructure3-part diff systems HumaCount 30TS and HumaCount 80TS in combination with solar charge and rechargeable battery HumaPower (accessories)
Basic Metabolic Panel
  • even in remote areas or regions with minimal infrastructure
  • Glucose (GOD method or Hexokinase method)
  • Calcium
  • Enzymatic electrolytes
  • Blood urea nitrogen
  • Creatinine (enzyme)
  • Clinical chemistry analyzer HumaLyzer 4000 in combination with solar charge and rechargeable battery HumaPower (accessories)
Testing for co-infectionsPlease refer to HIV and Malaria respectively
Testing for TuberculosisPlease refer to Tuberculosis

Pregnancy test: hCG

TypeDescriptionProduct name / item
Rapid Screening testDifferent Formats
ELISAFor the quantitative determination of hCGhCG

Syphilis

TypeDescriptionProduct name / item
Rapid Screening tests
  • Various formats: immunochromatographic, RPR and TPHA
Hexagon Syphilis, Syphilis RPR Test, Syphilis TPHA liquid
ELISAFor high sensitive antibody detection against Treponema pallidumSyphilis Screen ELISA

Tuberculosis (TB)

TypeDescriptionProduct name / item
Molecular detection by isothermal amplification  For remote laboratories and regions with poor infrastructure to replace smear microscopy. From level I to level IV labs.Closed system of reagents and instruments:
  • LoopampTM MTBC Detection Kit (exclusively* distributed by HUMAN)
  • LoopampTM PURE DNA Extraction Kit (exclusively* distributed by HUMAN)
  • HumaLoop T
  • HumaTurb system 

*excluding China, Japan, South Korea, Taiwan, and Thailand.