National Malaria Indicator Survey€¦ · Web viewStandard Operating Procedures (SOP) for malaria...

Ministry of HealthLusaka, Zambia

National Malaria Test and Treat Campaign November 2011,

Zambia

Standard operating manual for malaria Rapid Diagnostic Training

(RDT) testing and treatment

CONTENTS

Standard Operating Procedures (SOP) for malaria parasite testing during field work for the Test and Treat Campaign 2011....................3

Selecting participants..................................................................................3General precautions when taking blood......................................................4HemoCue general instructions....................................................................5

ICT MAL PF general instructions..........................................................5Intended Use................................................................................................5Summary.....................................................................................................5Principle......................................................................................................5Precautions..................................................................................................6Storage and Stability...................................................................................6Specimen collection and Preparation..........................................................6Materials......................................................................................................6Directions for use........................................................................................7Interpretation of results...............................................................................7Quality Control............................................................................................8Limitation....................................................................................................8How to do the RDT test.............................................................................10DOs...........................................................................................................10DON’Ts.....................................................................................................10

Blood slide general instructions.................Error! Bookmark not defined.Introduction................................................Error! Bookmark not defined.Materials required......................................Error! Bookmark not defined.Taking blood samples................................Error! Bookmark not defined.Making blood films and labeling...............Error! Bookmark not defined.Common errors in blood film preparationsError! Bookmark not defined.Dried blood spots.......................................Error! Bookmark not defined.Staining of blood films..............................................................................12

Summary of steps in collecting blood films and doing anaemia, RDT tests and slides in the field......................................................................12Treatment of positive cases....................................................................13

Anaemia.....................................................Error! Bookmark not defined.Malaria......................................................................................................13

Disposing of hazardous waste................................................................17Avoiding problems arising in the field..................................................18

Problems of haemoglobin testing in the field..........Error! Bookmark not defined.

Problems of parasitemia testing in the field..............................................18

Blood testing and treatment standard operating manual

Standard Operating Procedures (SOP) for malaria parasite testing during field work for the Test and Treat Campaign 2011

IntroductionOne testing procedureis being used to collect information on the presence of malaria parasites during the Test and Treat Campaign 2011 in Zambia . This is:

Malaria parasite testing using ICT MAL PF Rapid Diagnostic Tests (RDTs)

The procedures below are the Standard Operating Procedures (SOP), including the materials and methods that will be used for conducting this three test in household interviews during field work.

In addition, the treatment procedures for responding to positive test results are presented.

It is important that these SOPs be followed explicitly to promote standardized testing methods and to ensure good quality, consistent results for each test across all field teams.

Selecting participants1. We will test individuals of all ages in all households for malaria.

2. Consent must be obtained before the survey questioning and malaria parasite testing can begin. Every person whose blood is taken must have a check mark indicating that they have agreed to the blood tests.

Zambia Test and Treat Campaign 2011 of 22


General precautions when taking bloodPersonnel responsible for collecting blood for haemoglobin measurement must take precautions to prevent parenteral, skin, and mucous-membrane exposures to blood-borne infections, such as hepatitis B, or human immunodeficiency virus (HIV). Under general precautions the following rules should be followed to ensure protection from acquiring blood-borne infections.

(1) Wear new gloves for each patient. Gloves help to prevent skin and mucous-membrane exposure to blood. Gloves should be worn during blood collection and haemoglobin measurement until all specimens and materials are disposed of. Gloves must be disposed of as biohazardous wastes (see below under Disposal of Biohazardous Wastes). Gloves must never be reused!

(2) Avoid penetrating injuries. Although gloves can prevent blood contamination of intact and non-intact skin surfaces, they cannot prevent penetrating injuries caused by the instruments used for finger or heel pricks. Generally, self-retractable lancets are recommended to reduce the risk of penetrating injuries. If other devices are employed for testing, care should be taken to develop procedures to prevent such injuries. Whatever the type of lancet, it should not be used for purposes other than a single finger or heel prick to collect blood for the malaria and anaemia testing. The lancets should not be broken or destroyed for curiosity or other purposes.Immediately after pricking the patient, the lancet should be placed in a sharp disposal puncture-resistant container for further disposal without first putting it on the table or the test area surfece. Use a new lancet for each patient. (3) If an accident occurs, any skin surfaces or mucous membranes that become contaminated with blood should be immediately and thoroughly washed and the accident should be reported to the supervisor.PEP procedures should apply when ever there is a self prick with a used a needle or lacent .

(4) Eating, drinking, applying cosmetics, and handling contact lenses may distract the procedure and are not permitted during blood collection and haemoglobin measurement.

(5) Properly dispose of all biohazardous materials. All materials coming in contact with blood must be placed in biohazardous waste containers after use and disposed of according to the survey organization’s policy on infectious waste disposal (see below under Disposal of Biohazardous Wastes).

(6) The biohazardous waste containers should be labeled “biohazard.” Take precaution when storing and transporting the waste



containers during the fieldwork, and follow established procedures to ensure proper disposal of all waste products (see below under Disposal of Biohazardous Wastes).



ICT MAL PF general instructions

Intended UseThe Malaria P.f. Rapid Test Device (Whole Blood) is a rapid chromatographic immunoassay for the qualitative detection of circulating Plasmodium falciparum in whole blood.

SummaryMalaria is caused by a protozoan which invades human red blood cells. Malaria is one the world's most prevalent diseases. According to the WHO, the worldwide prevalence of the disease is estimated to be 300-500 million cases and over 1 million deaths each year. Most of these victims are infants and young children. Over half of the world's population lives in malarious areas. Microscopic analysis of appropriately stained thick and thin blood smears has been the standard diagnostic technique for identifying malaria infections for more than a century. The technique is capable of accurate and reliable diagnosis when performed by skilled microscopists using defined protocols. The skill of the microscopist and use of proven and defined procedures, frequently present the greatest obstacles to fully achieving the potential accuracy of microscopic diagnosis. Although there is a logistical burden associated with performing a time-intensive, labor-intensive, and equipment-intensive procedure such as diagnostic microscopy, it is the training required to establish and sustain competent performance of microscopy that poses the greatest difficulty in employing this diagnostic technology especially at the lower levels of health care provision.

The Malaria P.f. Rapid Test Device (Whole Blood) is a rapid test to qualitatively detect the presence of the P.f. antigen. The test utilizes colloid gold conjugate to selectively detect P.f. antigen in whole blood.

PrincipleThe Malaria P.f. Rapid Test Device (Whole Blood) is a qualitative, membrane based immunoassay for the detection of P.f. antigen in whole blood. The membrane is pre-coated with P.f. antibody. During testing, the whole blood specimen reacts with the dye conjugate, which has been pre-coated in the test strip. The mixture then migrates upwards on the membrane by capillary action and reacts with the P.f. antibody on the membrane on the test line. If the specimen contains P.f. antigen, a red line will appear in the test region. The absence of a red line in the test region indicates that the specimen does not contain any P.f. antigen. A red line will always appear in the control region, indicating that the proper volume of specimen was added and membrane wicking occurred.



Precautions For professional in vitro diagnostic use only. Do not use after

expiration date. For whole blood specimen use only. Do not use other specimens. Do not eat, drink or smoke in the area where the specimens or kits

are handled. Handle all specimens as if they contain infectious agents. Observe

established precautions against microbiological hazards throughout all procedures and follow the standard procedures for proper disposal of specimens.

Wear protective clothing such as laboratory coats and disposable gloves.

Humidity and temperature can adversely affect results.

Storage and StabilityStore as packaged in the sealed pouch at 2-37°C. The test device is stable through the expiration date printed on the sealed pouch. The test device must remain in the sealed pouch until use. DO NOT FREEZE . Do not use beyond the expiration date.

Specimen collection and Preparation The Malaria P.f. Rapid Test Device (Whole Blood) can be performed

using whole blood. To collect Finger stick Whole Blood specimens:

o Wash the patient’s hand with soap and warm water or clean with an alcohol swab. Allow to dry.

o Massage the hand without touching the puncture site by rubbing down the hand towards the fingertip of the middle or ring finger.

o Puncture the skin with a sterile lancet. Wipe away the first sign of blood.

o Gently rub the hand from wrist to palm to finger to form a rounded drop of blood over the puncture site.

o Add the Finger stick Whole Blood specimen to the test device by using a sucking bulb:

Lightly squeeze the sucking bulb and gently suck the blood until filled to the first mark (approximately 5 microlitres). Avoid air bubbles.

Then squeeze the bulb to dispense the whole blood to the specimen well (small round well) of the test device.

Whole blood specimens should be used at once after collection for optimum performance.

Materials



Individually packaged cassettes (Test devices) Buffer (reagent) Disposable sucking bulb Package insert Sterile lancet Sterile alcohol swab

Directions for useAllow the test device, specimen, buffer, and/or controls to equilibrate to room temperature (15-37°C) prior to testing.

1. Remove the test device from the foil pouch and use it as soon as possible. Best results will be obtained if the assay is performed within one hour.

2. Place the test device on a clean and level surface. 3. For Finger stick Whole Blood specimen: Fill the sucking bulb to the

first mark and transfer approximately 5 microlitres of fingerstick whole blood specimen to the specimen well of the test device by touch-blotting.

4. Add 5 drops of buffer, and then start the timer. See illustration below.

5. Allow the reaction to proceed for 15 minutes6. The result should be read at 15 minutes. Do not interpret the result

after 20 minutes. 7. NB. clear positive results can read before 15 minutes.

Interpretation of resultsPOSITIVE:* Two distinct Pink lines appear. One line (the control) should be in the control region (near the letter C) and another line (the test) should be in the test region (near the letter T).

*NOTE: The intensity of the pink color in the test line region (near letter T) will vary depending on the concentration of P.f. present in the specimen. Therefore, any shade of pink in the test region (near letter T) should be considered positive.



NEGATIVE: One Pink line appears in the control region (near the letter C). No apparent red or pink line appears in the test region (near the letter T).

INVALID: Control line fails to appear. Or only the test line shows without the test line. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test device.

Quality ControlInternal procedural controls are included in the test. A Pink line appearing in the control region (near letter C) is an internal positive procedural control. It confirms sufficient specimen volume and correct procedural technique.

Control standards are not supplied with this kit; however, it is recommended that positive and negative controls be tested as a good laboratory practice to confirm the test procedure and to verify proper test performance.

Limitation1. The Malaria P.f. Rapid Test Device (Whole Blood) is for in vitro

diagnostic use only. This test should be used for the detection of P.f. antigen in whole blood specimens only. Neither the quantitative value nor the rate of increase in P.f. antigen concentration can be determined by this qualitative test.

2. The Malaria P.f. Rapid Test Device (Whole Blood) will only indicate the presence of P.f. antigen the specimen and should not be used as the sole criteria for the diagnosis of malaria infection.



3. As with all diagnostic tests, all results must be interpreted together with other clinical information available to the physician.

4. If the test result is negative and clinical symptoms persist, additional testing using other clinical methods is recommended. A negative result does not at any time preclude the possibility of malaria infection.



How to do the RDT test- Sit or lie the person down- Check the expire date on the pouch- Open the test pouch: check that the desiccant is not wet and still

shakes; if not discard- Write the name , date and ID number (given by the PDA) onto the

cassette with the fine-tip marker or pencil.- Suck the sample to the first mark of the sucking bulb from the drop of

blood on slide done for the HemoCue analyze by lightly squeezing the sucking bulb

- Take 5 microlitres of blood using the sucking bulb provided, then touch blot on sample well (small round well).

- Hold the buffer bottle vertically upside down over buffer well (large round well) and let out exactly 5 drops

- Write time onto the cassette with the fine-tip marker or pencil.- Wait for 15 minutes before reading the test results- Make sure the control line shows (a pink line near letter C)- Then look at the test window: a positive test shows a pink line in the

test area( pink line near letter T). - A faint pink line also indicates a positive result.- Record the result in the PDA

DOs- Follow instructions carefully in performing the test- Store as packaged in the sealed pouch at 4-37°C DO NOT FREEZE- Label specimens as per MIS 2010 instructions(name, date and ID

number)- Handle all specimens as potentially infectious- Follow standard bio-safety guidelines of MIS 2010 for handling and

disposal of potentially infective material- Read the results at the end of 15 minutes. - However, if the background of the test window has not cleared within

this time, add 1-2 drops of buffer and wait for another 15 minutes before reading the results

- Clear Positive results can be read even before 15 minutes.Note: not negative results.

- Wear protective clothing such as disposable gloves when specimens are collected & processed

DON’Ts- Do not re-use the test device or lancet- Do not use the test device after the expiration date- Do not open the kit more than 5 minutes before doing the test as the

test is very sensitive to humidity. The test device must remain in the sealed pouch until just before use

- Do not mix reagents from different lots



- Do not eat, drink or smoke in the area where the specimens and kits are handled

- Do not use if pouch or devices are damaged or if any lines are visible on the device before contact with the specimen

- Do not use clotted blood for the test- Do not read the test before 15 minutes- Do not miss ‘faint positives’



Summary of steps in collecting blood films and doing anaemia, RDT tests and slides in the field

Open one pouch of RDT and label it with the PDA generated ID number,name of the patient and date

Remove one filter paper and label it clearly Clean the 4th finger tip with an alcohol swab Prick the finger using sterile lancet. Dispose of lancet in sharps

biohazard container(Do not re use a lancet) Take sample using sucking bulb for RDT (be fast to avoid blood

clotting on the slide before sampling).- Touch Blot the blood sample into sample well of the test device.

- Add 5 drops of buffer into the buffer well and indicate the time as shown on the test device.

Using the same sucking bulb, fill it with blood to the second mark and then squeeze it on one of the squares on the filter paper and repeat this on the other two squares on alternate positions.

Read the RDT result after 15 minutes. Record result in PDA. Give the necessary treatment(s) if applicable. Dispose of all materials in the right biohazard container. Pack and carry all the equipment for the next home Fix all the thin smears with methanol for the day The following morning individually pack all the well labelled air dried

filter papers individually in a medicine bag with a desiccant and zip it.



Treatment of positive cases Anyone who is seriously ill and/or needs further management will be referred to the nearest health facility. Transport will be provided in case of emergency.

MalariaPeople with a positive RDT result will be treated with Coartem®, except for pregnant women, who will be treated with quinine and children weighing less than 5 kgs who will be treated with Fansidar.



Artemether-Lumefantrine (Coartem®)

Tablet containing 20 mg Artemether plus 120 mg Lumefantrine in a fixed dose combination.

Weight(kg)

Age(Years)

Number of tablets per dose

Twice daily for 3 days Day 1 Day 2 Day 3First contact

8 hours later

Morning Evening Morning Evening

5 – 14 3 months – 2 years

1 1 1 1 1 1

15 – 24

3 – 7 years

2 2 2 2 2 2

25 – 34

8 – 10 years

3 3 3 3 3 3

35+ >10 Years

4 4 4 4 4 4

Side effects

The following adverse effects have been reported: dizziness and fatigue, anorexia, nausea, vomiting, abdominal pain, palpitations, myalgia, sleep disorders, arthralgia, headache and rash.

Contra-indications

- Malaria prophylaxis either alone or in combination.- Persons with a previous history of reaction after using the drug- Pregnant women, mothers with infants less than three months of age and infants less than five kg- Persons with severe malaria.

Note: Appropriate storage and use of Artemether-Lumefantrine

Artemether-Lumefantrine (Coartem®) has a short shelf life of two years only. It is a highly hygroscopic chemical compound; moisture and temperatures of 30°C and above severely affect its efficacy. To prevent this, therefore, the drugs should be stored at temperatures below 30°C and should not be removed from the blister if they are not going to be used immediately.



Artemether-Lumefantrine (Coartem®) is packaged as shown below.

Quinine

Quinine 8 mg base/kg 3 times daily for 7 days

Weight(kg)

Age years) Oral (tablets)Dosage to be given daily

200 mg salt 300 mg salt 4 – 6 2 – 4 Months 1/4 -

6 – 10 4 – 12 months 1/3 ¼ 10 – 12 1 – 2 years 1/2 1/3 12 – 14 2 – 3 years 3/4 ½ 14 – 19 3 – 5 years 3/4 ½ 20 – 24 5 – 7 years 1 ¾ 25 – 35 8 – 10 years 1 1/2 1 36 – 50 11 – 13 years 2 1 ½ 50+ 14+ 3 2

Fever Management in children aged five years and below

Classification and Treatment of the Child’s Fever



(Child Aged 2 Months to 5 Years)

Signs Classification Treatment

▪ Fever (by history or temperature 37.5c C or above)

MALARIA • Treat with sulfadoxine-pyrimethamine (SP).• If the child has already been appropriately treated with SP during this episode of fever, treat with oral quinine.• Do tepid sponging• Give one dose of paracetamol for fever of 38.5o C or above (see Table 4.14)• Advise the caretaker when to return immediately• Ask the caretaker to return in 2 days if fever persists • If fever is present every day for 7 days, refer for further assessment

▪ •

* Fever of 37.5c C does not require treatment with paracetamol; in this age group you should give paracetamol only when the child’s temperature reaches 38.5o C.



Disposing of hazardous waste Any material coming in contact with blood or serum (lancets, alcohol swabs, gauzes, and gloves) is considered to be biohazardous, i.e., hazardous to other human subjects. Safe disposal of such materials is very important to prevent the transmission and spread of various blood-borne diseases, such as Hepatitis B and HIV, among survey personnel and within the study community. Biohazardous wastes have to be collected in a special container during the parasitemia and anaemia testing, securely stored and transported, and safely disposed of at the end of each day of fieldwork at the near by health facility.

Materials and Supplies

The following items are required in the field for disposal of biohazardous materials after parasitemia testing:

Four percent sodium hypochlorite solution1

Matches or lighter Ziplock-type polyethylene bags Sharps container labelled "Biohazard" (for example, a wide-mouth

plastic jar).

Procedures for Field Disposal of Biohazardous Wastes

At the end of each blood collection , parasitemia and anaemia measurement, all materials used during the testing like gloves, alcohol swabs, sharps, microcuvettes, pipettes, wrappers, desiccants and gauze pads have to be placed in waste bins container (a wide-mouth plastic jar) and kept there until the end of the working day. NB. It is advisable to have two waste bins. One for sharps, microcuvettes and pipettes. The second one for all the other survey waste. The waste bins should be taken to the nearest health facility where they will be incinerated.

1 Four percent hypochlorite solution could be purchased as a commercially available product. It could also be prepared in the field by substituting a hypochlorite powder using water. The liquid solutions (sodium hypochlorite solution and kerosene) should be stored in leakproof and airtight containers



Avoiding problems arising in the field

Problems of parasitemia testing in the field1. "Milking" the finger. Excessive massaging or squeezing of the finger or foot will cause tissue juice to mix with and dilute the blood. This will result in erroneous test results, particularly in yielding low levels of parasitemia concentration in the blood. Instead, the tester should employ only mild pressure by using the thumb and the second and third fingers to make a "pad" at the puncture site. This will make the connective tissue underlying the skin more porous and allow the capillary blood to flow easily after the incision.

2. Mixing alcohol with the blood. Alcohol, which is used to clean the puncture site, can mix with the blood and cause errors in the parasitemia reading. Any residual alcohol will cause haemolysis and specimen dilution, as well as excessive platelet clumping, red blood cell aggregation, and sedimentation at the skin-puncture site.It will also fix the thick blood smears, which will make it difficult to reading the smears. To avoid this problem, the finger or heel must be allowed to air dry completely before being punctured.

3. Shallow puncture. A deep puncture should be made for better blood flow and to have a representative concentration of red blood cells.

4. Using the first or second drop of blood. Only the third or fourth drop of blood should be used for parasitemia testing. This ensures the free flow of blood and allows for the collection of blood with a representative concentration of red blood cells.

5. Obstructing blood flow. It is important to hold the finger properly to allow for the accumulation of blood in the puncture-site area. Holding the finger too tightly can obstruct the blood flow to the finger.

6. Not labeling the slide or the RDT. As the blood smear will be taken to another location to do the microscopy examination, it is critical that the glass slide is properly labeled so that the result can match with the child (or mother) when recorded. Similarly, the RDT result which may be read 10-15 minutes later must be properly labeled so that there is no mistake in linking the result to the child tested. Also both the used RDTs and slides will be required for quality control hence proper labeling is essential.

7. Improperly stored RDTs should not be used for testing. RDTs may have specific storage requirements and should not be used if these storage requirements were not followed. The cassettes must remain un opened until just before use to avoid exposure to moisture, which may destroy the reagents or alter the properties of the test.



8.Application of too much blood, when more than enough blood is applied the test area does clear fast and the reading of the results especially the faint positive results can easily be missed.


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