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.
| Type | Description | Product name / item |
|---|---|---|
| Blood count testing | Assessment of full 3-part CBC (complete blood count) even in remote areas or regions with minimal infrastructure | 3-part diff systems HumaCount 30TS and HumaCount 80TS in combination with solar charge and rechargeable battery HumaPower (accessories) |
| Blood count testing | Assessment of full 5-part CBC (complete blood count) with capillary or venous blood | HumaCount 5D |
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.
| Type | Description | Product name / item |
|---|---|---|
| Assessment of glucose plasma levels | Even in remote areas or regions with minimal infrastructure |
|
| 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.
| Type | Description | Product name / item |
|---|---|---|
| Clot assessment | For determination of prothrombin time (PT) by investigation of the extrinsic pathway |
|
| Clot assessment | For determination of the activated partial thromboplastin time (aPTT) by investigation of the intrinsic pathway | Hemostat aPTT-EL |
| Clot assessment | For determination of the thrombin time (TT) for the basic screening profile | Hemostat Thrombin Time |
| Clot assessment | For determination of fibrin clot formation (Clauss Method) to identify fibrinogen defects | Hemostat Fibrinogen |
| Turbidimetric assay | For immunologic determination of D-dimer for exclusion of deep vein thrombosis of the leg or pulmonary embolism | Hemostat D-Dimer |
HIV
| Type | Description | Product name / item |
|---|---|---|
| Rapid Screening Test | For HIV-1 and HIV-2 | Hexagon HIV |
| ELISAs |
|
|
Malnutrition
| Type | Description | Product name / item |
|---|---|---|
| Determination of nutritional factors | Assessment 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 infrastructure | 3-part diff systems HumaCount 30TS and HumaCount 80TS in combination with solar charge and rechargeable battery HumaPower (accessories) |
Pneumonia
| Type | Description | Product name / item |
|---|---|---|
| Blood count testing | Assessment of full 3-part CBC (complete blood count) even in remote areas or regions with minimal infrastructure | 3-part diff systems HumaCount 30TS and HumaCount 80TS in combination with solar charge and rechargeable battery HumaPower (accessories) |
| Basic Metabolic Panel |
|
|
| Testing for co-infections | Please refer to HIV and Malaria respectively | |
| Testing for Tuberculosis | Please refer to Tuberculosis |
Pregnancy test: hCG
| Type | Description | Product name / item |
|---|---|---|
| Rapid Screening test | Different Formats |
|
| ELISA | For the quantitative determination of hCG | hCG |
Syphilis
| Type | Description | Product name / item |
|---|---|---|
| Rapid Screening tests |
| Hexagon Syphilis, Syphilis RPR Test, Syphilis TPHA liquid |
| ELISA | For high sensitive antibody detection against Treponema pallidum | Syphilis Screen ELISA |
Tuberculosis (TB)
| Type | Description | Product 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:
|
*excluding China, Japan, South Korea, Taiwan, and Thailand.
