Hemoglobin Test Kit

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It is the most severe complication occurring of iron deficiency. Although preventable, but in its severe forms can prove life impairing and fatal. Mostly observed in pregnant women in developing countries, the no. of the cases is staggering high. Apart from general primary healthcare, the accurate evaluation of hemoglobin level can prove a crucial step, aiming to reduce the number of subjects affected.

Detection and management

Keeping track of hemoglobin levels has long been considered rudimentary in routine health checks. Hemoglobin level in blood as an indicator of anemia traditionally relies on the performance of well-equipped clinical laboratories. There are elementary methods of course, but are considerably pricy and need industry-grade chemical reagents along with a decent degree of technical skill and yet are inaccessible to peripheral health clinics. Especially in rural areas where anemia is common and appropriate prevention and treatment strategies shall be efficiently implemented, a parallel method is required to screen for anemia economically. The less sophisticated the device, the more conveniently one can respond. 

Solution

The concept that the color of a drop of blood could reliably indicate anemia emerged in the late 1900s. The blood had to be matched against predetermined hues of red, revealing if the subject was anemic along with the severity of it. Due to the lack of modern printing technology, there was a high chance that estimation could prove inaccurate. 

But with advanced tech, it is possible now to perfect the method through which the color accurately matches the shades of hemoglobin at different concentrations on the hemoglobin scale. Also, considering the cost implications of the management and the magnitude of the impact on socioeconomic stature of developing nations, crucial restrictive measures as screening the anemic patient using HBCS Kit are need to be undertaken swiftly.

How To Use

The Hemoglobin Color Scale contains a small card with six hues of red representing hemoglobin levels at 4, 6, 8, 10, 12 & 14 g/dl respectively. 

The device is simple to use:

• place a drop of blood on the test strip provided and wait about 30 seconds.

immediately match the color of the blood spot against one of the hues on the scale making it convenient enough to be used by most untrained hands showing whether the patient exhibits symptoms of anemia and if he/she does, then the severity of anemia in clinical terms. The color scale cannot identify minor changes in hemoglobin levels while the treatment but can aid in the management of a suspected patient. 

Field Validation

Since the year 1995, when early series of studies were performed by WHO, extensive testing and field trials had been carried out. A comparison was done in recent studies in Africa which clearly demonstrated that the scale proved to be far superior in terms of accuracy in detecting both mild and severe forms of anemia. Significantly, even the best results from the clinical examination could not match the lowest levels of performance. 

Sensitivity and specificity of the Scale to screen for anemia

For severe anemia, the scale shows a sensitivity of 95% and a specificity of 99.6%. To distinguish normal Hb levels from mild anemia, the sensitivity and specificity are 98% and 86% respectively, results that are well above the reliability of any clinical measurement.

Using a photometer (HemoCue) as a reference, the Scale was compared with the copper sulfate specific gravity method. The scale was accurate to 98% in distinguishing among 2,800 volunteer blood donors those with normal Hb from those rejected because of anemia. The Scale was more reliable than copper sulfate, the tests giving 2.4% and 5.4% false readings respectively. Moreover, copper sulfate presents a potential environmental hazard in the disposal of used solutions. 

Training

Most results were accurate to within 1-1.5 g/dl. in a validation study. Further, analysing the discrepancies in the results of the original study, it was observed that there were multiple reasons such as 

1. .Lack of training and thus incorrect technique, 

e.g., not waiting for 30 seconds, 

2. .Reading in low light conditions 
3. .Not having an adequately sized drop of blood.

which in turn resulted in causing inaccuracy in the final analysis. 

It has been observed that a half-hour training session was sufficient for healthcare professionals to estimate haemoglobin to within 1g/dl, and determine levels of anaemia with more accuracy effectively compared to orthodox clinical diagnosis. The importance of safe blood collection must be part of the training and the Starter Kit. 

The Kit Contents:

• booklet of 6 shades of red.
• instructions for use; dispenser of 200 especially absorbent test strips in a handy box.
• 4 spare dispensers (800 tests). Available in English, French and other languages as required.

Important:

• instructions for use must be followed.
• use only approved test strips provided (refill dispensers available). 

Quality Assurance

Quality is assured by the WHO collaborating centre for the validation of the printing and accuracy of the colour shades and the test strips.

How much is it?

The Starter Kit with approved test strips for 1,000 tests costs about US$ 66, which turns out to be cheaper than copper sulphate and considerably less than a laboratory test.